Medical Updates @ SBAmin.com

Oral Rivaroxaban completes Phase III

2007-07-08T23:55:00.000-04:00

In a race to replace warfarin and smoothen management issues of thromboembolic disorders by avoiding need for stringent therapeutic monitoring, newer oral anticoagulants are making their debut in the market soon. Rivaroxaban (BAY 59-7939) along with two newly developed molecules, Apixaban and Dabigatran etexilate are oral form of anticoagulant agents with a convenient fixed once or twice daily dose regime. ¹ Compare to Warfarin, these drugs do not require coagulation monitoring as being highly specific direct inhibitor of Factor Xa (Rivaroxaban, Apixaban) and Factor IIa (aka, Direct thrombin inhibitor - Dabigatran etexilate). Dabigatran is about to launch in market with completed phase 3 trial in orthopedics and currently running trials in stroke prevention ⁴.

Phase 3 trial, RECORD3 (REgulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) data from 2531 patients, lead by Michael R. Lassen, MD announced today at the XXI International Society on Thrombosis and Haemostasis (ISTH) Congress showed once-daily rivaroxaban (Xarelto®) achieved superior efficacy in the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement surgery in a head-to-head comparison with enoxaparin, the current standard of care therapy [49% relative risk reduction (RRR) (p<0.001)]. ² Importantly, rivaroxaban also demonstrated a similarly low rate of major bleeding compared to enoxaparin (0.6% and 0.5%, respectively). Considering potential hepatotoxiciy of direct thrombin inhibitors (i.e.: withdrawal of the direct thrombin inhibitor ximelagatran shortly after it reached the market ³), complete saftey profile of rivaroxaban is due till ongoing RECORD3 trial ends by 2007 end. To date, rivaroxaban is the most studied oral direct factor Xa inhibitor in development. More than 15,000 patients have been evaluated in the completed phase II programs and enrolled thus far in the phase III programs. More than 40,000 patients are expected to be evaluated in total. ⁴

Rivaroxaban is being jointly developed by Bayer HealthCare AG and Johnson & Johnson Pharmaceutical Research &amp;amp; Development (J&JPRD), L.L.C.

References:
1. Rivaroxaban Looks Promising in DVT - Medscape Heartwire
2. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery - Pressnote at Bayer Inc. | ISTH 2007 website
3. AstraZeneca Decides to Withdraw Exanta™ (melagatran / ximelagatran)
4. Currently active clinical trials from ClinicalTrials.gov

Oral Eltrombopag - A possible answer to Platelet Transfusions

2007-06-17T00:29:00.000-04:00

A newer oral form of therapy is expected soon in market for patients of chronic ITP and possibly for other patients suffering from symptomatic thrombcytopenia. Eltrombopag (Promacta ® - GSK pharma) is an investigational agent (SB 497115) of a new drug class, thrombopoeitin receptor (TPO-R) agonist which in turn showed significant increase in megakaryocyte proliferation and differentiation and thereby, raising platelet count with oral dosage of 50-75 mg/day for six-weeks and producing less frequent chances of bleeding. This was concluded from phase III trials, involving 114 patients from worldwide having platelet count less than 30000/cmm. Being a non-peptide, small molecule, drug has less immunogenic potential, compare to platelet antibody issue with platelet transfusions. Till date, no serious side effects have been reported in controlled trials and drug is in phase III trial for further safety checkup. Though drug showed impressive results in chronic ITP non-responders from conventional treatments (steroids, immunotherapy), it is currently not being evaluated in other causes of thrombocytopenia, especially in drug-induced thrombocytopenic cases.

Image courtesy: 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)

References:

1. Press Release at GSK | Medical News Today 12 June 2007

2. Ongoing clinical trials:

RAISE (RAndomized placebo controlled ITP Study with Eltrombopag)
REPEAT (Repeat ExPosure to Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura)
EXTEND (Eltrombopag Extended Dosing Study) and four others at clinicaltrials.gov

3. Original article presented presented at the 12th congress of the European Hematology Association (EHA) in Vienna, Austria

Bussel, J., Provan A., Shamsi T et al. Eltrombopag Raises Platelet Count and Reduces Bleeding compared with Placebo during Short-term Treatment in Chronic Idiopathic Thrombocytopenic Purpura: A Phase III Study. Presented 9th June 2007, 12th Congress of the European Hematology Association, Vienna, Austria

Related articles and Recent Study Outcomes:

Rosiglitazone update and Clinical Practice Guidelines: Type 2 DM

2007-06-06T00:26:00.000-04:00

FDA has released ¹ MedWatch alert for Avandia (rosiglitazone) in management of DM, concerning about risk of ischemic cardiovascular events which might be linked with the drug use. Alert is based on pooled analysis of 42 clinical trials. However, there is no definite evidence so far showing Avandia as a cause of such cardiac events.

Joslin Diabetes Center (JDC) has released (Jan 2007) updated clinical practice guidelines on adult with diabetes and pharmacological management of type 2 DM in non-pregnant adults. These evidence based guidelines contain essential points in managing diabetic patients with a systematic approach for an optimal blood glucose control and preventing diabetic complications. Guidelines are available in text layout at NGC and also in easy-to-follow algorithms at JDC's website ².

References:

1. FDA MedWatch: 21 May 2007 Avandia (rosiglitazone)

2. Guidelines may show update after actual posting date:

Clinical guideline for adults with diabetes: NGC | JDC (PDF)
Clinical guideline for pharmacological management of type 2 diabetes: NGC | JDC (PDF)

oropharyngeal cancer and oral sex

2007-05-13T04:07:00.000-04:00

Security is mostly a superstition. It does not exist in nature,....
(Helen Keller)

The quote seems true even in a personal life! Oropharyngeal cancer showed strong association with high-risk sexual behaviors, people having more than 5 oral-sex partners during lifetime and especially among partners having HPV-16 and other serotypes positive status, results recently published in NEJM. A Case-control study involving newly diagnosed oropharyngeal cancer and 200 control patients without cancer to evaluate associations between HPV infection and oropharyngeal cancer.

The degree of association increased with the number of vaginal-sex and oral-sex partners. Since this is a single study with fairly ok sample size, cause-and-effect association can not be established; but there is a strong correlation between oropharyngeal cancer and oral HPV infection, apart from use of alcohol and tobacco as an independent risk factors. Apart from oro-genital sex, even mouth-to-mouth direct contact may be linked to increase risk of acquiring oral HPV infection and subsequently oropharyngeal cancer.

Authors suggest public health implication of this study by expecting rise in oropharyngeal cancer cases because of increase oral sex practices behavior among adoloscents. Recently launched HPV vaccine (Gardasil, Merck Inc.), now under US national immunization schedule for girls between 11 to 12 years (extended 9-26 years age) can be a rational approach to prevent oral HPV infection and decreasing cancer risk in boys too. However, more clinical studies are demanded before arriving at conclusion to implement HPV vaccination among boys.

Reference:
1. D'Souza G et al. | Case–Control Study of Human Papillomavirus and Oropharyngeal Cancer | N Engl J Med 2007(10 May);356:1944-1956 (free access)
2. Oral Sex Can Add to HPV Cancer Risk | Time magazine
--

Helen Keller says to dare and face the outright danger. However, there are few exceptions prudent followers should know about. Play safe:-)

Cumulative Updates: Stroke Guideline | New Anti-Platelet drug in Phase 3

2007-04-25T02:14:00.001-04:00

Here are cumulative updates (shortlist) happened in recent two weeks. I am unable to post frequent regular updates because of tight schedule and limited internet connectivity. Alternately, use feed station for keeping eye on medical news.

1. Updated guidelines for treatment of acute ischemic stroke:
By American Heart Association/American Stroke Association (Apr 19, 2007, ahead of print issue of Stroke)

Major Recommendations/Changes since 2003 guidelines

Intravenous tPA is still recommended as the key treatment of stroke in patients presenting within 3 hours of the onset of stroke symptoms
Time is the key, activation of emergency medical services ASAP is the topmost priority
Upcoming role of intra-arterial tPA in patients with inaccessible intravenous line
Comaprision of benefits Vs risks using Mechanical Embolus Removal in Cerebral Embolism (MERCI) retriever (FDA approved) or tPA.
CT scan still remains preferred modality with only primary intetion to exclude hemorrhage event and plan for tPA treatment
MRI is acceptable alternative provided quick access is available

..... guidelines truncated

Refer Medscape article (link) or Stoke journal (May 2007 issue) for complete guidelines.

2. Newer Anti-platelet drug in Phase 3 clinical trial:
Newer class of oral anti-platelet drug (platelet PAR-1 receptor blocker) named TRA-SCH 530348 (Schering-Plough Inc.). In fact, it blocks the platelet PAR-1 receptor to which thrombin binds, thus inhibiting thrombin-induced activation of platelets, and is therefore classified as a thrombin-receptor antagonist (TRA). Recently reported phase 2 trial showed fewer ischemic events without increasing bleeding when added to standard antiplatelet therapy with aspirin and clopidogrel in patients undergoing PCI. Researchers from Duke and TIMI group have now planned two major phase 3 trials which will be accessing effect of this novel agent compare to placebo without adjuvant standard anti-platelet regime. Two groups of patients will include one for the treatment of acute coronary syndrome (ACS) patients (more than 10000 patients), and one for secondary-prevention in patients who have had a prior MI or stroke or who have existing peripheral arterial disease.
.....update truncated

Original press release at http://www.schering-plough.com/schering_plough/news/release.jsp?releaseID=987054
Courtesy: Medscape

Declining Breast Cancer & HRT effect

2007-04-19T11:18:00.003-04:00

Hormone Replacement Therapy (HRT) is again in the news, once again with possible causal association for developing breast cancer. Statistical analysis performed by M.D.Anderson's team revealed strong association (but no cause-to-effect relationship) between declining breast cancer cases and parallel decline in use of HRT in post-menopausal women since mid-2002. The decline occurred primarily in women age 50-69, the researchers find, and was predominantly seen in estrogen-receptor(ER)-positive cancer. Ravdin and Berry strongly stress, however, that their study is not suggesting that all women stop their use of HRT. "This study is not saying that an individual woman will reduce her absolute risk of developing breast cancer by 15 percent by immediately discontinuing use of HRT," Berry says.

Read brief report at EurekAlert! 18 Apr 2007
Original article: Ravdin PM et al. | The Decrease in Breast-Cancer Incidence in 2003 in the United States | N Engl J Med 2007(Apr 19);356:1670-1674

Inhaled Insulin (Exubera) - Falling Star

2007-04-19T11:18:00.001-04:00

Inhaled Insulin (Exubera) was brought in market in early-2006 and since then, it's being criticized for its added efficacy and long-term safety profile over standard subcutaneous insulin regime. Recently, National Institute for Health and Clinical Excellence (NICE, UK Government) has published guideline on use of inhaled insulin for the treatment of type 1 and 2 diabetes. Authors of guideline group do not recommend inhaled insulin for the routine treatment of diabetes.

Also, inhaled insulin should be used as an alternative option in only those subgroup of diabetic patients in whom other treatment modalities are ineffective or intolerable and interestingly, in patients suffering from specific phobia of "blood injection injury type" who are not willing to take standard subcutaneous insulin injections. Several other studies also recommend data collection for evaluating long-term safety profile of inhaled insulin and it's effect on lung functions.

Reference:
1. NICE guideline (Dec 2006): Inhaled insulin for the treatment of diabetes (types 1 and 2)
2. Exubera | Pfizer Inc.
3. FDA approval of Exubera
--

Vasopressin Antagonist in Acute Heart Failure - Mixed Results | EVEREST trial (ACC.07)

2007-03-30T14:49:00.000-04:00

American College of Cardiology's 56th annual scientific session (ACC.07) Update | March 26, 2007:

Vasopressin V2 receptor antagonist tolvaptan¹ is again showing mixed results with efficacy limited only to short-term benefits in fluid overload status. Previously, tolvaptan was found to be effective in patients with euvolemic or hypervolemic hyponatremia in increasing serum sodium concentrations at day 4 and day 30; with recurrence of hyponatremia was noted in a week after discontinuation of tolvaptan on day 30.² Now, EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure Trial) outcome presented at ACC.07 ³ suggested tolvaptan moderate efficacy only in short-term cure of acute decompensated hear failure (ADHF) without difference in all-cause mortality or the composite of CV death or heart failure hospitalization compared with placebo at long-term follow-up; suggesting that early, in-hospital therapy with tolvaptan is beneficial but longer therapy may be unnecessary. Explaining study results, Dr Marvin A Konstam said, tolvaptan can "facilitate fluid management" and alleviate symptoms in this population " with a well-defined and acceptable long-term safety profile." ⁴ This might because of drug action in decreased body weight, reduction in edema, and subsequent improvement in patient assessed dyspnea. The results of the present study are similar to those observed in the ACTIV in CHF trial⁵, which also showed improvements in acute heart failure symptoms but no difference in clinical endpoints with chronic therapy.

Reference:
1. Tolvaptan (OPC-41061) - In process of New Drug Application | Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is developing tolvaptan for the treatment of congestive heart failure, hyponatremia and polycystic kidney disease.
2. Previous article on SBAmin.com | N Engl J Med 2006;355:2099-2112 | ClinicalTrials.gov numbers, NCT00072683 [SALT-1]and NCT00201994 [SALT-2]
3. ACC.07 EVEREST trial link
4. EVEREST: "Modest" Gains, No Apparent Harm From Vasopressin Antagonist in Acute Heart Failure | Heartwire (WebMD) article
5. ACTIV in CHF | ACC.07 link
--

Ranolazine (Ranexa) has no role in Acute Coronary Syndrome (ACS) cases

2007-03-29T12:10:00.000-04:00

Hello All!
I am lagging behind updating this blog with several important clinical trial updates¹ recently presented at American College of Cardiology's 56th annual scientific session (ACC.07) and Innovation in Intervention: i2 Summit 2007 (see reference for official outline links)
--
ACC.07 update (March 27, 2007): Ranolazine (Ranexa) has no role in Acute Coronary Syndrome (ACS) cases | MERLIN TIMI-36 results
Ranolazine (Ranexa)² is a new class of anti-anginal drug, approved by FDA³ in January 2006 for the treatment of chronic angina patients who have failed to other forms of angina treatments (long-acting nitrates, calcium channel blockers and beta blockers). This indication was based on initial clinical trials, namely ERICA⁴ (Efficacy of Ranolazine in Chronic Angina) and CARISA⁴ (Combination Assessment of Ranolazine In Stable Angina) involving more than 1300 patients. Studies found prolong QT interval as a adverse reaction which might lead to proarrythmic effects and hence, drug is restricted for use in chronic angina patients as a second-line option.

The new trial named, MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes)⁴ was started in May 2006 which was a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of Ranexa during acute and long-term treatment in approximately 6,500 patients with non-ST elevation ACS treated with standard therapy. The primary efficacy endpoint in MERLIN TIMI-36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study was also evaluating the safety of long-term treatment with Ranexa compared to placebo.⁵ Results of MERLIN TIMI-36 were presented at ACC.07 which showed no role of Ranolazine in management of patient with ACS and also it has not disease-modifying effects in stable angina patients. However, trial showed no adverse effects of drug in terms of arrhythmia and increase mortality because of its prolong QT interval side-effect and suggested that it might have antiarrhytmic effects.

Effect of Ranolazine in preventing recurrent angia is supported by all major clinical trials. It is a unique agent that, unlike other classes of anti-anginal therapy, does not significantly reduce heart rate or blood pressure. As MERLIN study has shown better safety profile of Ranolazine, it is likely that Ranolazine will gain one more indication as a first-line therapy in stable angina patients in coming years.⁶ Precise mechanism of action of Ranolazine is unclear but it is believed to be a selective inhibitor of the late sodium current relative to peak sodium channel current, and via this mechanism, it may decrease sodium-dependent intracellular calcium overload during ischemia and reperfusion.⁷

Reference:
1. ACC.07 | i2 Summit 2007 : Official Text and Multimedia Resources | MERLIN TIMI-36 outline
2. Ranolazine (Ranexa)^® prescribing information from CV Therapeutics
3. FDA approval of Ranolazine: January 31, 2006
4. Clinical trial summary from ACC: CARISA | ERICA | MERLIN TIMI-36 (May require ACC account access)
5. CV Therapeutics article, dated 9 July 2006 - medicalnewstoday.com
6. MERLIN: No Role for Ranolazine in ACS but First-Line Indication in Stable Angina Now Likely - Heartwire (WebMD) news
7. Hale SL, Kloner RA | Ranolazine, an inhibitor of the late sodium channel current, reduces postischemic myocardial dysfunction in the rabbit | J Cardiovasc Pharmacol Ther. 2006 Dec;11(4):249-55 | PMID: 17220471
--

Patch: Pfizer stopped phase 3 trial of potential HDL raising drug

2007-03-26T12:44:00.000-04:00

This is a patch to an update posted earlier 03 Dec 2006.

Today NEJM has published (available free at this time) early release articles¹ to coincide with presentations at a meeting of the American College of Cardiology². These articles elaborate possible mechanisms of adverse effects of CETP inhibitor torceptrapib (Pfizer Inc.) because of which Pfizer has terminated phase III clinical trials³ of promising HDL lowering agent drug.

Reference:
1. Articles available free for the time being at NEJM homepage. These articles will be in print format in March 29 and April 19, 2007 issue of NEJM.
2. American College of Cardiology 56th annual scientific session in New Orleans & 2nd Annual Innovation in Intervention | ACC.07 and i2 Summit 2007
3. Terminated clinical trials: Investigation of Lipid Level Management to Understand Its Impact in Atherosclerotic Events (ILLUMINATE) (ClinicalTrails.gov search: Torcetrapib/Atorvastatin) | Investigation of Lipid Level Management Using Coronary Ultrasound to Assess Reduction of Atherosclerosis by CETP Inhibition and HDL Elevation (ILLUSTRATE) trial (NCT00134173)
--
Original post - 03 Dec 2006:

On December 2, 2006, FDA was notified that Pfizer will suspend a large, Phase 3 trial evaluating the investigational cardiovascular therapy torceptrapib/atorvastatin (T/A) due to an increased rate of mortality (death) in patients receiving the combination compared to those receiving atorvastatin alone...excerpt from FDA News

Torceptrapib was a potent inhibitor of cholesteryl ester transfer protein (CETP). Read Effects of an Inhibitor of Cholesteryl Ester Transfer Protein on HDL Cholesterol NEJM 350:1505-1515 (2004)
--

Creatine for Parkinson's Disease - Phase III trial

2007-03-23T13:12:00.000-04:00

The National Institute of Neurological Disorders and Stroke (NINDS), NIH institute yesterday¹ launched double-blind, placebo-controlled, phase III study to learn if the nutritional supplement creatine can slow the progression of Parkinson's disease (PD). Currently there is no treatment that has been shown to slow the progression of PD. It is one of the largest PD clinical trials to date, enrolling 1720 people with early-stage PD at 51 medical centers in the United States and Canada. Till date, creatine is not an approved therapeutic agent for PD or any other condition. Earlier studies² suggest its ability to improve exercise performance possibly by improving mitochondrial function and potential neuroprotection by antioxidant property. Creatine - a widely used dietary supplement has been investigated as a possible therapeutic approach for the treatment of muscular, neurological, neuromuscular diseases and neuroprotective effects.³ Participation in this study lasts a minimum of 5 years and includes at least 9 follow-up clinic visits and at least 3 telephone calls.

Reference:
1. NET-PD LS-1 Creatine in Parkinson’s Disease | NCT00449865
2. PubMed search using keywords: creatine parkinson
3. Creatine and treatment of muscular diseases | Wikipedia.org

Estriol pills for Multiple Sclerosis

2007-03-23T12:21:00.000-04:00

UCLA researchers have begun phase II/III multi-center clinical trial¹ of Estriol treatment for Relapsing Remitting Multiple Sclerosis (RRMS). Multiple sclerosis (MS) relapses are known to be significantly decreased during pregnancy as described in earlier clinical studies. This proposal will establish whether oral treatment with estriol, the major estrogen of pregnancy, induces a decrease in relapses in relapsing remitting multiple sclerosis (RRMS) subjects when used in combination with injectable Copaxone (glatiramer acetate)². Previously, in a pilot study, it has been demonstrated that treatment of RRMS subjects with oral estriol for six months resulted in a significant reduction (approximately 80%) in gadolinium enhancing lesions on serial brain MRIs³ and caused a favorable shift in immune responses⁴. Current study is an add-on study aiming to extend these previous findings by treating longer and focusing on clinical outcomes. The combination of Copaxone injection plus estriol pill (8 mg per day) will be compared to Copaxone injection plus placebo pill in a double blind trial. The duration of treatment will be two years and the primary outcome measure will be relapse rate. Treatment with estriol is believed to be a neuroprotective against new MS attacks as well as to reduce severity of inflammatory reaction seen with MS. Trial is expected to be completed by July 2011 and team expect to come up with promising results which would be helpful to cut down existing expensive MS treatment with cheaper hormone pills. Recently University of Calgary team shown protective effect of hormone prolactin in preventing demyelinating episodes in animal studies.

Courtesy: EurekAlert! 22-Mar-2007

Reference:
1. A Combination Trial of Copaxone Plus Estriol in RRMS (Estriol in MS) | NCT00451204
2. Copaxone prescribing information | PDF
3. Annals of Neurology, 2002; 52:421-428
4. Journal of Immunology, 2003; 171:6267-6274

Eculizumab (Soliris) for paroxysmal nocturnal hemoglobinuria (PNH)

2007-03-21T18:44:00.001-04:00

FDA recently (March 19) approved Eculizumab - a humanized monoclonal antibody with long-acting C5 terminal complement inhibitor property. It is a new class in immunotherapy selectively blocking terminal complement activation - one of the main component of innate immune system. Patients with PNH are hypersensitive to complement mediated intravascular hemolysis as their RBCs lacks complement-regulating surface proteins, i.e. decay-accelerating factor (DAF) or CD55, homologous restriction factor (HRF) or C8 binding protein, and membrane inhibitor of reactive lysis (MIRL) or CD59. However, Soliris helps only in preventing complement mediated hemolysis and decreasing need for excess blood transfusions but it does not alter the course of PNH as well as potential risks of thrombosis and aplastic anemia associated with PNH. A boxed warning showing risk for serious meningococcal infection and need for meningococcal vaccination is affixed following results of clinical trials.

Reference:
1. FDA Okays Eculizumab (Soliris) for Paroxysmal Nocturnal Hemoglobinuria - MedPage Today
2. Hilmen P et al. | Effect of Eculizumab on Hemolysis and Transfusion Requirements in Patients with Paroxysmal Nocturnal Hemoglobinuria | N Engl J Med 2004;350:552-559
3. eMedicine.com article on PNH
--

Don't kiss, focus on chest

2007-03-19T18:45:00.001-04:00

I mean title for cardiopulmonary resuscitation (CPR) !

Chest compressions alone are more life saving than combined chest compressions with mouth-to-mouth rescue breathing in adults having cardiac arrest - based on results from a large scale study in Japan involving 4000 cases of cardiac arrest outside hospital in presence of bystanders. This is because patients in whom heart has just stopped working can have adequate oxygen saturation in flowing blood to support brain and other vital organs functions until heart recovers and restart pumping oxygenated blood. Hence, rather spending time on rescue breathing from those precious early life-saving minutes, it is prudent to deliver continuous effective chest compressions in anticipation of restarting heart pump and preventing ischemic brain damage.

However, this conclusion was based from a single study data involving patients having failing heart and it is important to note that rescue breathing can be a vital task when it comes to respiratory component in cardiac arrest. i.e. narcotic and drug over-dosage, drowning and others. There have been no change in CPR guidelines so far from American Red Cross and American Heart Association (AHA).

Reference:
1. 'Kiss of life' increases risk after heart attack - NewScientist News 16 March 2007
2. American Red Cross - Video showing current CPR technique
3. Cooper et al. | Cardiopulmonary Resuscitation: History, Current Practice, and Future Direction | Circulation 2006;114:2839-2849
--

FDA MedWatch: Erythropoiesis Stimulating Agents & Interferon Gamma 1-b

2007-03-19T12:28:00.000-04:00

Erythropoiesis Stimulating Agents
FDA MedWatch has issued black box warning for use of Erythropoiesis Stimulating Agents (ESAs) namely, darbepoetin (Aranesp) and epoetin alfa (Epogen and Procrit)

Studies showed aggressive use of ESAs to correct hemoglobin 12 g/dl or more is associated with increase risk of thrombotic events and stimulate progression of some cancers. (DAHANCA 10, CREATE, CHOIR and other studies)

in raising hemoglobin to 12 g/dl or higher in cancer patients which is associated with higher chance of serious and life-threatening side effects or death. Revision took place after results of four clinical trials evaluating an unapproved dosing regimen, a patient population for which ESAs are not approved, or a new unapproved ESA. Patients treated with Aranesp had a higher death rate and no reduction in the need for transfusions compared to those treated with placebo. The findings in the Aranesp study may apply to other ESAs. Additionally, the findings show that treating anemic cancer patients not currently on chemotherapy with an ESA may offer no benefit and may cause serious harm.

Current recommendation for all indicated patients are:

To start the lowest possible dose of ESAs.
Checking hemoglobin twice a week for two to six weeks after any dosage change to ensure that hemoglobin has stabilized in response to the dose change.
Withhold the dose of the ESAs if the hemoglobin increase reaches 12 g/dL or more or rises by 1g/dL in any two-week period.

[FDA Source]

Interferon Gamma 1-b
FDA has not approved Interferon Gamma 1-b (Actimmune) for the treatment of idiopathic pulmonary fibrosis (IPF) based on early termination of the INSPIRE clinical study of Actimmune for IPF because of an interim analysis showed that patients with IPF who received Actimmune did not benefit compare to placebo.

[FDA source]

Oral Amphotericin B - Bypassing Renal toxicity

2007-03-05T13:43:00.000-05:00

Researchers at the University of British Columbia (Canada) discovered new drug delivery system for Amphotericin B (AmB), bypassing notable renal toxicity associated with currently available intravenous AmB formulation. Newer oral preparation containing lipid-based AmB targets specifically fungal cells while inhibiting drug's interaction with kidney cells - thereby avoiding lethal toxicity and increasing efficacy. This can be a boon for thousands of patients suffering from dreaded fungal infections associated with HIV/AIDS and other immuno compromised diseases by providing more effective, less toxic and cheaper alternative to intravenous AmB. A clinical study of the drug delivery system, involving 50-100 patients, is planned for later this year. Study led by Wasan KM will be presented today at a meeting sponsored by the American Association of Pharmaceutical Scientists in Washington, D.C. Findings will be published in July 2007 in Drug Development and Industrial Pharmacy.

Use of Liposomal AmB (AmBisome®) is associated with raised serum creatinine level in 18% to 40%; hematuria in 14% of cases and acute renal failure and/or toxic renal nephropathy in 2% to 10% of cases. However, incidence of decreased renal function and infusion-related events are lower than rates observed with conventional amphotericin B deoxycholate (Amphocin®, Fungizone®).²

Reference:
1. EurekAlert! 5-March-2007
2. Drug information by Merck Inc. - Liposomal AmB
3. AmBisome monograph
--

Clinical Practice Alert: For Entecavir and Vancomycin use

2007-03-01T00:19:00.000-05:00

Clinical Practice Alert:

1. Entecavir (Baraclude ^TM) in patients suffering from both - Chronic Hepatitis B and HIV infection:
Hopkins researchers proved deleterious effect of Entecavir in patients suffering from HBV / HIV co-infection using both laboratory and clinical tests. Entecavir - A selective HBV polymerase inhibitor is indicated for chronic active HBV and being widely used since arrival in March 2005. As there have been cases showing decrease viral load of HIV with use of entecavir in such co-infected patients, current practice widely favors use of entecavir in treating HBV in HIV/HBV patients not simultaneously receiving highly active antiretroviral therapy (HAART) in anticipation of decreasing HIV load. However, Hopkins study cautions clinicians not to use entecavir in HIV/HBV patients they revealed mutation in HIV (M184V type) which nurtures HIV resistance to more widely used Lamivudine (3TC) and related Nucleoside reverse transcriptase inhibitors (NRTIs) which might be needed for HIV therapy in later phase for those patients. At present, there is no box warning for use of entecavir in HIV/HBV co-infected patients. On 24-Feb-2007, FDA included entecavir in MedWatch [Excerpt: Current treatment guidelines recommend Baraclude as an option for treatment of HBV in the HIV/HBV co-infected adult patient who does not qualify for HAART. Healthcare professionals are advised that when considering therapy with Baraclude in an HIV/HBV co-infected patient not receiving HAART, the risk of developing HIV resistance cannot be excluded based on current information]
Reference:
1. EurekAlert! 28-Feb-2007
2. Conference on Retroviruses and Opportunistic Infections (CROI) 2007
3. Baraclude: official website | mechanism of action

2. Vancomycin dependant immune thrombocytopenia:
A study from the Medical College of Wisconsin, published today in NEJM reports development of vancomycin-dependant antiplatelet antibody and subsequent thrombocytopenia with significant bleeding. Study found 29 patients developing such antibodies and 3 of which had fatal bleeding outcome. Vancomycin, commonly used for MRSA is out in clinical practice for 25 years and therefore, this new finding reflects possibility of rarest side-effect and/or other unknown etiology of such antibody development despite study documented exclusion of other causes of thrombocytopenia. Authors recommend to actively watch for decreasing platelet counts / asking hematology consultation if justified and to discontinue/substitute vancomycin for few days to expect improvement in platlet counts.
Reference:
1. Aster et al. | Vancomycin-Induced Immune Thrombocytopenia | N Engl J Med 2007;356:904-910

Fulvestrant for Advanced ER positive Breast Cancer

2007-02-26T20:30:00.000-05:00

Fulvestrant (Faslodex®) - a competitive estrogen-receptor antagonist is relatively new class of endocrine treatment option in treatment of advanced breast cancer, besides commonly prescribed Tamoxifen (SERM - see reference) and Anastrozole (ARIMIDEX® - selective non-steroidal aromatase inhibitor). Approved in 2002 for use in post-menopausal estrogen receptor (ER) positive female with advanced metastatic breast cancer after failure of anti-estrogen therapy (i.e. tamoxifen), earlier studies (see Reference) clearly shown fulvestrant is as effective as anastrozole.

Recently published (Oct 2006)

Clinical implications:

Investigate role of Fulvestrant as a first-line adjuvant endocrine therapy for metastatic breast cancer
To study role of fulvestrant in delaying initiation of chemotherapy and associated side effects in endocrine resistant breast tumors

results of phase II Swiss Group for Clinical Cancer Research Trial (SAKK 21/00) stated significant clinical benefit in 30 % cases who had progressed despite prior aromatase inhibitor (AI) treatment. This benefit with fulvestrant was noted irrespective of response to an AI. Study concluded fulvestrant as a safe, well tolerated and effective therapy advanced metastatic breast cancer in post-menopausal patients with failure of anti-estrogen therapy and/or resistant to AI treatment.

Reference:
1. Journal Watch | Fulvestrant for Aromatase-Inhibitor–Resistant Breast Cancer
2. Fulvestrant clinical trials | PubMed PMID: 12177099, 15937908, 17030543
3. Prescription Information: Faslodex® | ARIMIDEX®
4. Selective estrogen receptor modulator (SERM) - Wikipedia article
--

Old is Gold | Circumcision in HIV prevention

2007-02-24T01:15:00.000-05:00

In a long running debate of questionable efficacy of adult male circumcision in preventing HIV infection, series of articles (including two recent study trials) published today in the Lancet showed more than 50 % relative reduction of HIV infection in circumcised adult heterosexual males and importantly without change in sexual behavior of studied population. NIH led trials conducted in Uganda and Kenya over duration of more than 24 months were stopped early as interim analysis showed significant benefit of circumcision. This would soon lead to integrate adult male circumcision as a new approach combined with other HIV prevention strategies

Till date more than 30 cross-sectional studies have found the prevalence of HIV to be significantly higher in uncircumcised men than in those who are circumcised and 14 prospective studies all show a protective effect, ranging from 48% to 88%. Current conclusion is primarily drawn from results of three major randomized control studies involving nearly 10000 adult males performed in South Africa, Uganda and Kenya by different researchers.

Pathophysiology and possible mechanism of HIV prevention by circumcision:

The protective effect of circumcision against HIV infection is thought to derive in part from postsurgical development of a barrier layer of keratinised squamous epithelial cells that limit viral entry to underlying HIV target cells (Langerhans’ cells, CD4+ T cells and macrophages). Without circumcision, inner mucosal surface of the human foreskin, when exposed upon erection, has nine times higher density of HIV target cells (and even more when person has recent history of sexually transmittable disease) than does cervical tissue and thereby increasing chance of acquring infection from vaginal cavity.
Other less satisfactory mechanisms among uncircumcised males include poor hygiene, greater incidence of ulcerative sexually transmitted infections and susceptibility of the foreskin to abrasions.

Obstacles in HIV prevention:

All three trials are stopped early may overestimate efficacy when compared with subsequent studies, and therefore demanding long-term post-circumcision trial surveillance is essential to determine the overall effectiveness of circumcision in populations with varying HIV prevalence.

When? Whether neonate circumcision would be effective strategy or not will at least take a generation to show any benefit if present and on the other side, performing adult male circumcision has its own challenges. i.e.: Complexity and safety of procedure, readiness for voluntary circumcision considering religious and cultural practices, public awareness and expenses related to current heath care system, especially in resource poor set-up.

At present, it is not sure whether or not male circumcision has any benefit in HIV prevention in female partners. Logically by creating herd of circumcised males, females risk of getting infection can be minimized.

Efficacy of circumcision in areas where male-to-male HIV transmission is greater than heterosexual transfer; importantly greater risk to recipient of anal intercourse.

Rising debate of male circumcision is mutilation, or whether it is justified for health, religious, and cultural reasons.

Upcoming global strategies:
The best way in halting HIV juggernaut is a multi-modality approach involving more than one existing preventive methods in co-operation with public, government and social agencies to create awareness and self-implication of central theme: Safe Sexual Practice

Courtesy and Ref.:

Lancet 24 Feb 2007 | Volume 369 Number: 9562

Editorial | Newer approaches to HIV prevention | Lancet 2007;369:615

Comment | Male circumcision to cut HIV risk in the general population | Lancet 2007;369:617-620

Bailey et al. | Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial | Lancet 2007;369:643-656

Gray et al. | Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial | Lancet 2007;369:657-666

Sawires et al. | Male circumcision and HIV/AIDS: challenges and opportunities | Lancet 2007; 369:708-713

Multiple Sclerosis (MS) linked with Prolactin

2007-02-21T00:28:00.000-05:00

For the first time, researchers from University of Calgary have found scientific basis of MS remission in pregnancy. Animal study involving pregnant mice showed increased level of Prolactin hormone during pregnancy promotes myelin production and thereby protect against demyelinating episodes. Although it is debatable whether prolactin has any potential for MS therapy, scientists expect to conduct clinical trials in coming years.

Ref.:
1. EurekAlert! Feb 20, 2007 post
2. Journal of Neuroscience Feb 21, 2007 issue

Recent update in MS:

FDA Approves Resumed Marketing of Natalizumab (Tysabri) Under a Special Distribution Program - FDA news June 5, 2006

European guidelines on the management of valvular heart disease (VHD)

2007-02-16T21:01:00.000-05:00

The European Society of Cardiology has issued (Jan 26, 2007) its first ever European guidelines on the management of valvular heart disease (VHD). Recommendations are based on EuroHeart Survey data and differ very little from those published by ACC/AHA (USA) recommendations last year. European experts are emphasizing on

Risk stratification among elderly patients to properly guide for surgical interventions,
Use of stress testing to select ideal candidates for intervention among rising pool of asymptomatic cases which are detected because of increase use of echocardiography and
Integrative approach involving patient and other medical disciplines rather single echo-based strategy for disease intervention

Guideline highlights are summarized here (For CME credit, visit links given in Ref.)

Ref.:
1. News source: Hearwire ©2007 Medscape Feb 15, 2007 (get CME here)
2. Guideline availability: Eur Heart J. 2007;28:230-268
3. ACC/AHA 2006 Guidelines for Management of Patients with Valvular Heart Disease - Executive Summary: Guidelines.gov (html), ACC and AHA websites (pdf)

Pulsed Corticosteroids Provide No Further Advantage in Kawasaki Disease

2007-02-15T13:05:00.001-05:00

Clinical trial performed by Harvard physicians showed no significant benefit of corticosteroids in controlling vasculitis associated with Kawasaki disease and long-term coronary complication. Randomized clinical trial revealed patients in the methylprednisolone group did have a shorter initial period of hospitalization (p=0.05) and, at week 1, a lower erythrocyte sedimentation rate (p=0.02), but the two groups had similar numbers of days spent in the hospital, numbers of days of fever, rates of re-treatment with immune globulin, and numbers of adverse events.
"Our data do not provide support for the addition of a single dose of pulsed intravenous methylprednisolone to conventional therapy in the routine primary treatment of Kawasaki disease" - Newburger's statement to HeartWire (Medscape Inc).

Kawasaki disease, an acute idiopathic self-limiting vasculitis that occurs in childhood is most common in Japan, although it affects children of all ethnic backgrounds. About 4000 cases of Kawasaki disease occur in the US each year, and the incidence is on the rise; In fact, it has replaced acute rheumatic fever as the leading cause of acquired heart disease in children in the US and Japan. Coronary artery aneurysms develop in 15% to 25% of untreated children and can lead, over time, to ischemic heart disease. American Heart Association advise long-term follow-up to monitor for coronary involvement in all cases of Kawasaki disease. Intravenous immune globulin therapy plus aspirin has been shown to blunt the acute inflammation and reduce the risk of coronary artery damage, with routine treatment cutting the rate of coronary artery aneurysms detectable on echo to around 5%.

Ref.:
1. Medscape News Feb 15, 2007
2. Newburger et al., Randomized Trial of Pulsed Corticosteroid Therapy for Primary Treatment of Kawasaki Disease - N Engl J Med 2007;356:663-675

Drug-eluting Coronary Stents: Conflicting Evidences and Rising Concerns

2007-02-13T16:51:00.000-05:00

NEJM has published early release articles on safety and efficacy of drug-eluting coronary stents. Majority of articles shows meta-analysis of clinical trials and pivotal studies performed by researchers worldwide using commonly available drug-eluting stents - Cypher (sirolimus-eluting) and/or the Taxus(paclitaxel-eluting). Early release is intended as editors believe the recent concern that the implantation of drug-eluting stents, as compared with bare-metal stents, may be associated with a small increased risk of late stent thrombosis.

Excerpt from NEJM articles:

Significant increase in the rate of stent thrombosis with drug-eluting stents in the period following the initial 12 months post-implantation (defined as late stent thrombosis)
No significant differences in the stent thrombosis rate between drug-eluting and bare-metal stents.
Significant increase in mortality for diabetics who received Cypher (sirolimus-eluting) stents.
No difference between death or myocardial infarction rates for patients who received Cypher stents versus bare-metal stents.
Significant increase in three-year mortality for patients who received drug-eluting stents versus patients treated with bare metal stents.

Although above findings are conflicting with previous pivotal studies and importantly NEJM conclusions are drawn from meta-analysis of often same data by different authors, researchers agreed drug-eluting stents almost eliminate the problem of restenosis and significantly reduce the need for revascularization compared with bare-metal stents.

One of the priority action as suggested by Samin Sharma, M.D., director of the cardiac catheterization laboratory at Mount Sinai Heart Institute in New York is to consider use of anti-platelet agent Clopidogrel (Plavix) first before taking patient for balloon angioplasty, concurrent use of Clopidogrel for intial three years may be helpful preventing late-onset thrombosis of drug-eluting stents.

Alhtough FDA advisers in last December agreed that drug-eluting stents are both safe and effective when used in stable patients with single-vessel disease, it remains uncertain about long-term safety and efficacy of such stents.

Ref.:
1. N Engl J Med: Early Release Articles (Published online on Feb 12, 2007,ahead of print publication date: march 8, 2007 issue)
2. MedPageToday.com report: Drug-eluting Coronary Stents-A Wealth of Data and Little Agreement

Updated - Recommended immunization schedules for children and adolescents: United States, 2007

2007-02-12T14:35:00.000-05:00

American Academy of Pediatrics Committee on Infectious Diseases and Centers for Disease Control and Prevention have updated Recommended immunization schedules for children and adolescents:The changes to the previous childhood and adolescent immunization schedule, published January 2006, are as follows:

* The new rotavirus vaccine (Rota) is recommended in a 3-dose schedule at ages 2, 4, and 6 months. The first dose should be administered at ages 6 weeks through 12 weeks. With subsequent doses administered at 4 to 10 week intervals. Rotavirus vaccination should not be initiated for infants aged >12 weeks and should not be administered after age 32 weeks.
* The influenza vaccine is now recommended for all children aged 6 to 59 months.
* Varicella vaccine recommendations are updated. The first dose should be administered at age 12 to 15 months, and a newly recommended second dose should be administered at age 4 to 6 years.
* The new human papillomavirus vaccine (HPV) is recommended in a 3-dose schedule with the second and third doses administered 2 and 6 months after the first dose. Routine vaccination with HPV is recommended for females aged 11 to 12 years; the vaccination series can be started in females as young as age 9 years; and a catch-up vaccination is recommended for females aged 13 to 26 years who have not been vaccinated previously or who have not completed the full vaccine series.
* The main change to the format of the schedule is the division of the recommendation into two schedules: one schedule for persons aged 0 to 6 years and another for persons aged 7 to 18 years. Special populations are represented with purple bars; the 11 to 12 years assessment is emphasized with bold, capitalized fonts in the title of that column. Rota, HPV, and varicella vaccines are incorporated in the catch-up immunization schedule.

Updated guidelines and convenient tables are provided at CDC website (link). Tables reproduced here for information of health care professionals only.

Ref.:
1. Guidelines.gov ID:10393
2. Human papillomavirus vaccine (HPV) - Gardasil Prescription Information from Merck Inc.
3. FDA Safety Alert on Menactra (Meningococcal Conjugate Vaccine A, C, Y, and W135 from Sanofi Pasteur Inc.): Reports of Guillain Barre Syndrome (GBS) associated with vaccine use.

Click images to enlarge:

#end

Revised Guideline for Venous Thromboembolism Management

2007-02-11T23:36:00.000-05:00

American College of Physicians and the American Academy of Family Physicians published clinical practice guideline for management of Venous Thromboembolism on 29 January 2007 which appeared in February 6, 2007 issue of Annals of Internal Medicine. Free full text is available at link given at the end of post. Major recommendations are as follows:

Low-molecular-weight heparin (LMWH) rather than unfractionated heparin should be used whenever possible for the initial inpatient treatment of deep venous thrombosis (DVT). Either unfractionated heparin or LMWH is appropriate for the initial treatment of pulmonary embolism.
Outpatient treatment of DVT, and possibly pulmonary embolism, with LMWH is safe and cost-effective for carefully selected patients and should be considered if the required support services are in place.
Compression stockings should be used routinely to prevent postthrombotic syndrome, beginning within 1 month of diagnosis of proximal DVT and continuing for a minimum of 1 year after diagnosis.
There is insufficient evidence to make specific recommendations for types of anticoagulation management of VTE in pregnant women.
Anticoagulation should be maintained for 3 to 6 months for VTE secondary to transient risk factors and for more than 12 months for recurrent VTE. While the appropriate duration of anticoagulation for idiopathic or recurrent VTE is not definitively known, there is evidence of substantial benefit for extended-duration therapy.
LMWH is safe and efficacious for the long-term treatment of VTE in selected patients (and may be preferable for patients with cancer).

Ref.:
Management of Venous Thromboembolism: A Clinical Practice Guideline from the American College of Physicians and the American Academy of Family Physicians, Snow, Qaseem et al., Annals 2007;146:204-210

Developing Reasoning Skills among medical residents

2007-02-10T18:03:00.001-05:00

Clinical reasoning skills is one of the important parameter in resident learning and evaluation. More medical schools are now changing their curriculum strategies to clinical 'case/problem solving' than relying on cramming theoretical aspects of medicine. Recently published editorial article in NEJM focuses on developing and testing such interactive reasoning skills for better performance in academic hospitals. Read more at N Engl J Med 2007;355:2251-2252

Lung Cancer in Non-Smoker Females

2007-02-09T21:26:00.001-05:00

Rising number of lung cancer cases in female sex is an alarming public health issue. Apart from more and more females are smoking every day- a proven risk factor of lung cancer; Stanford researchers have recently come up with new findings showing rising number of lung cancer even in non-smoker females.

Wakelee, Chang et al. team pooled data of new lung cancer cases from population of more than 1 million between ages of 40 to 79 in USA and Sweden.

Team suggest further studies to check for confounder bias because of secondhand smoke exposure and/or other environment pollutants effects which could explain part of the gender difference.

They found that for women, the lung cancer incidence rate in never-smokers ranged from 14.4 to 20.8 cases per 100,000 person-years. In men, it ranged from 4.8 to 13.7 incidents. More alarming is incidence of lung cancer in women are near equal to that of female cervical and thyroid cancer cases (15.4 and 17.3 cases per 100,000 person-years, respectively). Team suggest further studies to check for confounder bias because of secondhand smoke exposure and/or other environment pollutants effects which could explain part of the gender difference. If such bias are excluded, this data will be useful to understand molecular mechanism behind non-smoking related lung cancer and thereby, developing molecular based cancer therapies.
Ref.:
Wakelle et al., Lung Cancer Incidence in Never Smokers, JCO 2007;25:472-478

Articles of Interest: PAP and PCOS

2007-02-07T22:24:00.001-05:00

Pulmonary Alveolar Proteinosis (PAP)

A rare lung disease characterized by periodic acid-Schiff (PAS) positive floccular material accumulation in the alveoli which is derived from surfactant phospholipids and protein components. PAP can be idiopathic or secondary to lung infections, inhalation of mineral dusts and insecticides; and immune dysfunction associated with hematologic malignancies and AIDS. Congenital PAP is observed in neonates deficient in surfactant-associated protein B (SP-B). Recently, GM-CSF dysfunction and thereby, resultant macrophage dysfunction is postulated as a key mechanism in pathogenesis. Disease usually occurs in Male sex with 20-50 years of age with gradual onset of dyspnea and dry cough. Approximately 25-30 % remain asymptomatic with positive Chest X-ray. Flexible bronchoscopy with bronchoalveolar lavage (BAL) with PAS staining remains the standard for diagnosis. HRCT and Transbronchial biopsies may aid further in diagnosis. Prognosis varies depending on co-existing illness and PAP progression and lung function. Mechanical removal of the lipoproteinaceous material by whole-lung lavage remain mainstay for management. GM-CSF role in treating PAP is currently investigated. Lung transplantation should be considered with congenital PAP and in adult patients with end-stage interstitial fibrosis and cor pulmonale.
Ref.:
1. eMedicine article on PAP
2. N Engl J Med 2007; 356:567-579
--

Polycystic Ovary Syndrome

Recently published study in NEJM shows conventional anti-estrogenic therapy (Clomiphene) is superior to Metformin - targeting insulin resistance which is one of the mechanism of hormonal imbalance in PCOS. Read study article and editorial view at following links.
1. Legro RS et al., Clomiphene, Metformin, or Both for Infertility in the Polycystic Ovary Syndrome N Engl J Med 2007; 356:551-566
2. Guzick, D. S., Treating the Polycystic Ovary Syndrome the Old-Fashioned Way. N Engl J Med 2007; 356: 622-624
--

Updated Guideline for first UTI in children 12 years of age or less

2007-02-06T14:53:00.000-05:00

By Cincinnati Children's Hospital Medical Center
Nov 23, 2006

Guideline provides information on prompt diagnosis based on clinical features, urine analysis and appropriate management and follow-up of presumptive and definite case of UTI in children 12 years of age or less.
Guideline Highlights

See complete Evidence Based Guideline for details and supporting evidences.

Urinary Tract Infection (UTI)

Include: Twelve years of age or less with a first time presumed or definite episode of UTI
Exclude: Known immunodeficiencies, major genitourinary anomalies, sepsis with shock or meningitis, ICU need, ventilator care, and severe comorbid conditions
Goal: To help practitioners promptly diagnose UTI and to initiate appropriate treatment and follow-up evaluation to decrease risk of short and long-term outcomes

Recommendations
1. A dipstick/urinalysis and urine culture on a specimen collected by age appropriate method (SPA, catheterization, midstream clean catch) is recommended for all children presenting with clinical findings consistent with UTI.
2. If dipstick/urinalysis results are abnormal, empirical antibiotic therapy for presumed UTI is recommended.
3. Admit if: under 30 days of age, IV fluids or IV antibiotic therapy are required, high risk clinically or by laboratory data, or clinician or family is uncomfortable managing in an outpatient setting.
4. Reliable urine cultures results are the following:
SPA > 1,000 cfu/mL
Catheterized specimen > 10,000 cfu/mL
High quality midstream clean catch specimen > 100,000 cfu/mL.
5. If urine culture is positive, antibiotic therapy for 7-14 days is recommended, followed by prophylactic antibiotics until results of imaging studies are available.
6. Assess clinical response and C&S results within 48-72 hours and adjust antibiotic or other care, if appropriate.
7. Imaging recommendation for all boys, girls <> 3 yrs and all girls > 7 yrs: consider observation without imaging for first time UTI. If UTI recurs, US and cystogram recommended.
9. Renal cortical scan recommended only if identification of acute pyelonephritis or renal scarring will change management.
10. After first UTI, recommend families and clinicians maintain a high index of suspicion for recurrent UTI, and to obtain a dipstick/urinalysis and/or culture for age-appropriate symptoms of UTI, including unexplained fever.

Copyright © 2006 Cincinnati Children's Hospital Medical Center; all rights reserved.

Ref.:
1. National Guideline Clearinghouse™ (NGC) ID:10163
2. Cincinnati Children's Hospital Medical Center web page on UTI guidelines (PDF copies available)

Levetiracetam for monotherapy in epilepsy patients

2007-02-05T22:22:00.000-05:00

Europe based researchers Brodie et al. provided class 1 evidence of efficacy of levetiracetam (Keppra®, UCB Inc) as a monotherapy to control epilepsy in patients who don't respond to or can't tolerate existing treatments, according to a study published in the February 6, 2007 issue of Neurology®.
Study involved nearly 600 adults who had at least two seizures in the previous year to the drug levetiracetam or to controlled-release carbamazepine. Compare to carbamazepine, levetiracetam found to be well-tolerated, safe and easy-to-use drug (minimal drug interactions, less protein bounding and no cytochrome P450 isoenzymes dependent metabolism). Levetiracetam is currently approved as an adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy; and in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
[Ref.:NEUROLOGY 2007;68:402-408 Keppra® official website]

Talk less, Listen more

2007-01-31T19:36:00.001-05:00

Being proactive in communication skills is increasingly becoming of importance for intensive care unit (ICU) physicians who deal with end-stage diseased patients to minimize ICU-related post-traumatic stress disorder (PTSD) among families of the patient. As physician divert his/her plan from definitive treatment to palliation, effective system of communication is essential for balancing patient/family's perception, expectations to reality and prognosis.

Following are several recommendations from the editorial article published in NEJM 356:513-515 (Feb 1, 2007):
1. Implementing proactive communication system: A five-part system, known by the mnemonic VALUE, includes the following elements: Valuing and appreciatingwhat the family members communicate, Acknowledging their emotionsby using reflective summary statements, Listening to family members, Understanding who the patient is as a person by askingopen-ended questions and listening carefully to the responses,and Eliciting questions from the family more effectively than by simply asking, "Any questions?"
2. A key skill is listeningmore and talking less.
3. Formal bereavement meetings improves well-being and decrease PTSD, anxiety and depression among family members. ( Lautrette et al.)
4. Spending an average of 30 minutes (or 10 minuteslonger than typical practice) with the patient's family membersleads to a significant improvement in their well-being in themonths after their loss. (Lautrette et al.)
5. Multidisciplinary communication system including bereavement conferences should be arranged in accordance with ethics and palliative care consultations.
--

Word of caution for IMG trend in USA

2007-01-30T01:05:00.001-05:00

Recruiting more International Medical Graduates (IMGs) in near future may not be beneficial if goal of US health care is to raise number of practicing general internists - A study published on 29-Jan-2007 in the journal of general internal medicine (J Gen Intern Med. 2006;21(10):1045-1049) concluded.

A prospective cohort study with pooled data from two hundred and four categorical residents from two university-based residency programs analyzed factors involved in choosing general internist as a primary profession or to advance further in internal medicine sub-specialty. Researchers measured sociodemographic and personality attributes influencing career decision. Conclusion is alarming for IMGs as it states recruitment of IMGs may not increase the supply of General Internists. If increasing generalist manpower is a goal, residencies should consider weighing applicants' personal attributes during the selection process. On the other side,demand for primary care physicians boomed to 55% and 46% for general internists in just one year (3/2005-3/2006) - according to Hawkins & Associates, a physicians recruiting firm ( CBS News) This gap will widen in coming years unless personal career interests of applicants are balanced against health care need of population.
[ Read free full text at Medscape]
--

New Guidelines for Asymptomatic Carotid Artery Screening

2007-01-27T16:43:00.001-05:00

Jan 26, 2007

The American Society of Neuroimaging and Society of Vascular and Interventional Neurology recently published guidelines for screening for asymptomatic extracranial carotid artery disease. Recommendations are based on data from general and high-risk populations as well as results from various interventional studies. i.e.: NASCET (North American Symptomatic Carotid Endarterectomy Trial), ACAS (Asymptomatic Carotid Atherosclerosis Study), and SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy).

According to the current recommendations, doppler ultrasound is the preferred method of screening for extracranial carotid disease and the prevalence of asymptomatic carotid artery stenosis ranges between 2% and 18% among the general population. Asymptomatic carotid stenosis frequently warrants surgical treatment — among patients with a surgical risk less than 3% and a life expectancy of at least 5 years, carotid endarterectomy may be considered for lesions in which stenosis exceeds 60%. Endarterectomy may also be considered for patients with an operative risk between 3% and 5% if carotid stenosis is equal to or greater than 75% bilaterally. Patients who should be screened for carotid stenosis include patients older than 65 years with significant cardiovascular risk factors undergoing coronary artery bypass grafting, patients with symptomatic peripheral vascular disease, patients who received radiation therapy for head and neck cancer, and patients with a history of retinal ischemic events.

Guideline however does not cover choice of imaging modalities. Most of the evidence on patient selection in the literature is based on Doppler ultrasound. Hence, future updates may be required other noninvasive modalities including magnetic resonance angiography (MRA) or computed tomographic angiography (CTA) replace Doppler ultrasound.

[Source: J Neuroimaging. 2007;17:19-47 ; Medscape News]

MRI is better than non contrast CT scan in Acute Ischemic Stroke assessment

2007-01-27T16:04:00.001-05:00

NIH study shows immediate non-contrast MRI is about five times more sensitive than and twice as accurate as immediate non-contrast CT for diagnosing ischemic stroke. Also, Non-contrast CT and MRI were equally effective in the diagnosis of acute intracranial hemorrhage. Currently, non-contrast CT has been the standard in emergency stroke treatment, primarily to exclude hemorrhagic stroke, which cannot be treated with clot-busting therapies in a initial critical period of three hours. Authors predicts MRI to become the preferred imaging technique for diagnosing patients with acute stroke in near future.

Study performed by physicians at the National Institute of Neurological Disorders and Stroke (NINDS) published in Jan 27, 2007 issue of the Lancet. The study included 356 consecutive patients with suspected stroke arriving at the NIH Stroke Center at Suburban Hospital in Bethesda, MD. Results of the study show standard MRI is superior to standard CT in detecting acute stroke and particularly acute ischemic stroke. The four readers were unanimous in their agreement on the presence or absence of acute stroke in 80 percent of patients using MRI compared to 58 percent using non-contrast CT. No significant difference using the two technologies was seen in the diagnosis of acute intracranial hemorrhage, which is consistent with previous findings. Authors also suggested initial clinical assessment of stroke patient as key element and warranted further study to know feasibility of contrast enhanced CT scan as a rapid and affordable method.
[Lancet 369: Jan 27, 2007]

Moral conflicts: Ashley X case

2007-01-24T18:23:00.001-05:00

Ongoing conflicts between supporters and critics in a recently published (Arch Pediatr Adolesc Med. 2006;160:1013-1017) case report of Ashley X who is suffering from Static encephalopathy with marked global developmental deficits made me think of NEJM's article " can we prevent cerebral palsy?" publishes in year 2003. Unfortunately, there has been practically no success in either preventing or treating static encephalopathy/cerebral palsy. As seen in Ashley's case, current approach targets modalities to improve quality of life of patients by means of multi-disciplinary interventions which also includes controversial surgical and hormonal based palliation.
--

Beyond examinations !-)

2007-01-24T17:45:00.001-05:00

Assessment in Medical Education: Free full text article on clinical assessment of students and physicians
N Engl J Med. 356:387-396 (2007)
--

Newer biomarkers for CHD in clinical practice

2007-01-24T17:24:00.001-05:00

C-Reactive Protein (CRP), B-type natriuretic peptide (BNP) and N-terminal fragment of its prohormone (NT-proBNP) have been proposed for risk stratification in coronary heart disease (CHD). Recently, study published in Archives of the Internal Medicine compared efficacy of these markers for predicting future CHD events in patients with established CHD. Rothenbacher et al. showed NT-proBNP measurement is a better risk stratification tool than CRP measurement among patients with established CHD. Unlike CRP level, NT-proBNP measurement is associated with a greater increase in risk per unit increment in biomarker levels, as well as a larger increment in the area under the receiver operating characteristic curve (AUROC). These findings are consistent with those from several recent studies, including an analysis from the Heart Outcomes Prevention Evaluation (HOPE) trial in which NT-proBNP was compared with multiple novel inflammatory markers, including CRP. Authors concluded following with emphasis on "To Do" things before single risk stratification test (NT-proBNP levels) can be established in the routine clinical practice for patients with established CHD.

Threshold and serial values of NT-proBNP need to be defined for decision making (i.e.:Lipid Management)
Better understanding of temporal changes between test value and disease activity is needed so that the optimal frequency of measurement can be determined.
Determine what the end users (clinicians and patients) should do differently on the basis of an elevated NT-proBNP level in patients without heart failure.

Until these criteria are met, measurement of BNP or NT-proBNP for risk stratification in patients with or at risk for CHD should be performed selectively rather than routinely.
[Original source: Arch Intern Med. 166:2428-2430 (2006)]
--

Stomach banding surgery effective for adolescents: NYU Study

2007-01-23T14:37:00.001-05:00

Laparoscopic adjustable gastric banding (LAGB) aka Lap band surgery appears to be an effective procedure to combat obesity in adolescents, according to a new study conducted at NYU Medical Center. It is the first study to evaluate the lap band in patients under the age of 17, and it revealed that patients on average lost about 50% of their excess weight by one year after surgery. Currently, the lap band device is only approved by the Food and Drug Administration for use in adults. [J Pediatr Surg. 42:137-142 (Jan 2007)]

NYU Medical Center is one of three sites currently approved by the FDA to study the efficacy of the gastric band in adolescent patients.

Lap band surgery was performed on 53 morbidly obese adolescents between the ages of 13 and 17, according to the study. Most of the patients were girls. People are considered morbidly obese when their body mass index is at 40 or above, usually about 100 pounds overweight.

Conclusion of the study showed: Laparoscopic adjustable gastric banding is not only a safe operation for morbidly obese pediatric patients, but also represents an effective treatment strategy with a %EWL (excess weight loss) of approximately 50% at both 1 year and 18 months of follow-up. Because of the minimal morbidity and complete absence of mortality of the LAGB, it is the optimal surgical option for pediatric patients with morbid obesity.

New guidelines for assessing lymphoma treatment

2007-01-23T14:21:00.001-05:00

The new guidelines developed by the International Harmonization Project (IHP) build on criteria for treatment response assessment of non-Hodgkin's lymphoma published in 1999 by an international working group (IWG) of clinicians, radiologists and pathologists. Although the IWG criteria have been widely adopted by clinicians and regulatory agencies and used to approve several treatments, recent advances, including increased use of positron emission tomography (PET) scans and immunohistochemistry in lymphoma response assessment, prompted the IHP to substantially revise the criteria. The recommendations appeared online in the Jan. 22 online issue of the Journal of Clinical Oncology [ Journal of Clinical Oncology, 10.1200/JCO.2006.09.2403].

Excerpt from revised guidelines:

Integration of PET represents a major change in the guidelines. Co-author Juweid: These revised criteria for response assessment of lymphoma are unique in that they are the first for any cancer type to formally integrate functional imaging with PET into the more conventional response assessment using clinical, laboratory and radiological measures.
"Many patients with either diffuse large B-cell lymphoma (DLBCL), which is the most common subtype of lymphoma, or Hodgkin's disease, who were previously considered in partial response to treatment based on the conventional assessment, will now be considered in complete response if their PET scan is negative. Such patients can be safely observed and are expected to have an excellent outcome," Juweid said.
For two potentially curable types of lymphoma, DLBCL and Hodgkin's disease, the guidelines recommend that PET always be used to assess post-treatment response. PET also is strongly recommended prior to treatment to determine extent of disease for these lymphomas.
The guidelines also address when a scan should be performed and recommend that PET obtained for response assessment at therapy conclusion be done preferably six to eight weeks after completion of chemotherapy and eight to twelve weeks after radiation. Timing is important because inflammation, which is present in the early weeks following treatment of the tumor, can cause false positive PET scans.

--
[News Source: EurekAlert! Jan 23, 2007]

Gonorrhea - linked to bladder cancer

2007-01-10T03:08:00.000-05:00

In a first ever prospective study of its type, Harvard researchers showed significant association between gonorrhea and increased risk of bladder cancer in male. Researchers are now focusing on whether the organism itself is a causal factor or associated symptoms could be the triggering event.
http://www.nature.com/bjc/index.html [BBC News]
--

Incretin Mimetics in Type 2 DM

2006-12-10T15:22:00.000-05:00

Gosh! Lots of updates in MedWorld and I am completely unaware of new class of OHA which was approved in early 2005. Incretin (Glucagon-like peptide-1 GLP-1) Mimetics are new type of OHA which act by enhancing glucose-dependent insulin secretion in presence of hyperglycemia, inhibit glucagon secretion in hyperglycemic state and delay gastric emptying. Of importance, they do not enhance insulin secretion or suppress glucagon during hypoglycemia. FDA approved Exenatide ( Byetta ) in April 2005 as a combination therapy for patients of type 2 DM who have not achieved adequate control with metformin or sulfonylurea type 2 DM management. It is available in subcutaneous injectable form. Exenatide is eliminated mainly by kidneys and therefore, cation is advised in end-stage renal disease. Common side effects are hypoglycemia (increased risk when taken with sulfinylurea) and gastrointestinal upset. Few other agents ( Liraglutide, CJC-1131, ZP-10 and Albugon) are in clinical trial under same category.

Another subset of Incretin Mimetics is Dipeptidyl Peptidase-IV (DPP-IV) Inhibitors, vildagliptin and sitagliptin (Januvia) are in late-stage clinical development. They work by inhibiting DPP-IV, an enzyme that breaks down GLP-1 and thereby increasing GLP-1 levels. Fasting plasma glucose levels were slightly reduced, and reductions in postprandial glycemic measures were dominating. Advantage of DPP-IV inhibitors class include avaialbility of drug in oral form, minimum GIT adverse effects and minimal risk of weight gain. However, this class metabolize wide variety of peptides ( e.g., peptide YY, neuropeptide Y, growth hormone–releasing hormone, vasoactive intestinal polypeptide) and therefore potentially affect other regulatory systems. CD26, DPP-IV plays an important role in T-cell activation, and the inhibition of DPP-IV is theoretically associated with adverse immunologic reactions. The long-term safety of DPP-IV inhibition are currently evaluated in large trials.

To know more about clinical-pharmacological aspects of Incretin Mimetics,
View Medscape article Incretin Mimetics and Dipeptidyl Peptidase-IV Inhibitors : Potential New Therapies for Type 2 Diabetes Mellitus
Exenatide ( Byetta )

Tolvaptan in Hyponatremia ; Acute MI and Coronary intervention strategies

2006-11-14T13:06:00.000-05:00

Tolvaptan, an orally activevasopressin V₂-receptor antagonist in management of euvolemic or hypervolemic hyponatremia:

Euvolemic (caused by SIADH, Water intoxication syndrome, Responce to heightened emotional or pain stimuli, Hypothyroidism, Corticosteroid deficiency) or Hypervolemic (caused by CHF, Cirrhosis of liver, Nephrosis, Renal failure) hyponatremia is a commonly encountered problem in in-patient settings. Currently, no effective therapy is available to treat such patients (Current Management modalities and adverse events: water deprivation, careful administration of hypertonic saline; pontine and extrapontine myelinolysis are potential hazards if correction occurs too rapidly)

Recently conducted two RCTs suggested efficacy of tolvaptan in patients with euvolemic or hypervolemic hyponatremia in increasing serum sodium concentrations at day4 and day 30. (ClinicalTrials.gov numbers, NCT00072683 [SALT-1]and NCT00201994 [SALT-2].) However, recurrence of hyponatremia was noted in a week after discontinuationof tolvaptan on day 30. Tolvaptan - an orally activevasopressin V₂-receptor antagonist promotes aquaresis - excretion of electrolyte-free water. Read early release article at NEJM November 14, 2006 (10.1056/NEJMoa065181)

Other articles of interest in same issue are related to Acute Myocardial Infarction and Coronary intervention strategies:
Myocardial Infarction and the Open-Artery Hypothesis
Treatment of Coronary In-Stent Restenosis with a Paclitaxel-Coated Balloon Catheter
Treatment of In-Stent Restenosis — Back to the Future?
Reducing the Door-to-Balloon Time for Myocardial Infarction with ST-Segment Elevation
Coronary Intervention for Persistent Occlusion after Myocardial Infarction

Activated protein C (Xigris) in CV Stroke; Eye in Cerebral Malaria

2006-11-06T13:15:00.000-05:00

Eye as a diagnostic tool for Cerebral Malaria:
The eye can provide a very reliable way of diagnosing cerebral malaria, researchers in Malawi have shown. Cerebral malaria is accompanied by changes in the retina, the light-sensitive tissue at the back of the eye. These changes, known as malarial retinopathy, include white, opaque patches, whitening of the infected blood vessels, bleeding into the retina and swelling of the optic nerve. The first two of these signs are unique to severe malaria, and not seen in any other disease. [EurekAlert! link]

Tonsils and Streptococcal Infection:
Children with recurrent strep throat whose tonsils have not been removed are over three times more likely to develop subsequent episodes of strep throat than children who undergo tonsillectomy, according to a Mayo Clinic study published in the Nov. 2 issue of Laryngoscope. [EurekAlert! link]

Activated protein C (APC - Xigris^®): New drug to watch for in CV Stroke
After a decade long of TPA use - only available treatment for CV Stroke, now doctors and scientists at the University of Rochester Medical Center have developed a potential new treatment that can be breakthrough in the next few months, when FDA approved trial of treating 72 patients of CV stroke in four communities around the nation, including Rochester in next few months. Currently, APC is indicated in adults with severe sepsis with high risk of death. APC offers a potential way to temper the side effects of TPA and to increase the treatment "window" beyond three hours. Zlokovic and colleagues have demonstrated that APC protects brain cells that are under siege in multiple ways. In the laboratory, Zlokovic and colleagues have shown that APC counters a great deal of this damage, saving most of the brain cells that otherwise die and reducing the impact of stroke by 70 percent. His team first showed that TPA itself can kill neurons and amplify a stroke, then demonstrated that APC protects brain cells from the toxic effects of TPA and slows down the cascade of signals that causes more brain cells to die. They've also shown that APC helps quell inflammation.....

If you wish to know in detail about this exciting drug tiral, please visit follwing links:

EurekAlert! News (2-Nov-2006): Doctors launch new effort to treat stroke more effectively
Nature Medicine November issue (upcoming)
Activated protein C (Xigris^®)

Caution for boys if you found her hot:-)

2006-10-11T11:26:00.000-04:00

Sometimes we may find such articles in original research article :-)

...."Near ovulation, women dress to impress, and the closer women come to ovulation, the more attention they appear to pay to their appearance," said Martie Haselton, the study's lead author and a UCLA associate professor of communication studies and psychology. "They tend to put on skirts instead of pants, show more skin and generally dress more fashionably." Interestingly, it was found that even total strangers could detect a difference in women's grooming habits when they approached ovulation. Conventional wisdom has long held that humans hide all signs of ovulation, even from themselves and their mates.

Haselton, Bleske-Rechek and three UCLA students tracked 30 college coeds in committed relationships through an entire ovulatory cycle. Using urine tests that are nearly as accurate for determining ovulation as ultrasounds, they ascertained each woman's most fertile period -- about 10 to 15 days after menstruation -- and their least fertile period -- roughly the two weeks following ovulation. The researchers photographed the women twice: once in their fertile (follicular) phase and another time in their non-fertile (luteal) phase. To ensure that only the women's attire, grooming and accessories were taken into account, researchers masked participants' faces in the photographs with black ovals.

Researchers then arranged the photos in pairs on a kind of scientific version of the Web site "Hot or Not." Forty-two judges -- a little more than half of them women -- were asked, "In what photo is the person trying to look more attractive."

Read original news article at EurekAlert!

[This study is avaiable online at Oct. 10 issue of online version of the journal Hormones and Behavior - require subscription]

Newer rmAb in ARMD

2006-10-05T00:44:00.000-04:00

FDA has approved ranibizumab (Lucentis) for the treatment of neovascular age-relatedmacular degeneration. Ranibizumab [and Bevacizumab (Avastin)] are recombinant humanized monoclonal IgG1 antibodies against vascular endothelial growth factor (VEGF) A. The Fab domain of ranibizumab differs from the Fab domain of bevacizumab by six amino acids, five on the heavy chain (four of which are in the binding site) and one on the light chain which increase ranibizumab's affinity and thereby inhibiting power to VEGF A. Read clinical trials in N Engl J Med 2006;355 No.14

calcineurin - possible applications

2006-09-24T07:42:00.000-04:00

A Stanford team study found calcineurin as an important protein for health of beta islets of pancreas. Transplant patients' receiving calcineurin inhibitors (Cyclosporin, Tacrolimus and Pimecrolimus ) as immuno-suppressive therapy have greatly increased risk of developing diabetes which led researchers to investigate calcineurin actions. The researchers said drugs that enhance the activity of calcineurin or NFAT could become a new treatment for type-2 diabetes, in which the beta cells do not produce enough insulin.... [Nature 443, 345-349(21 September 2006), Original BBC link]

Calcineurin - a serine/threonine protein phosphatase (PP3 or PP2B) second messenger system protein is involved in many vital biological processes including dephosphorylation of nuclear factor of activated T cell (NFATc), a transcription factor that can then go into the nucleus and turn on genes involved in IL-2 synthesis for subsequent T-cell activation and differentiation in cytotoxic T-cells and NK cells.....Read more at http://www.unc.edu/~hke/cncyp.html , http://en.wikipedia.org/wiki/Calcineurin

Also to watch out: Calcineurin helps newborns breathe easy: Calcineurin role in fetal lung maturity 21 Sep 2006
--

DREAM trial: ramipril is not effective in treatment of Type 2 DM

2006-09-15T12:29:00.000-04:00

Diabetes Reduction Assesment with Ramipril and Rosiglitazone Medication (DREAM) trial showed ramipril use is not effective for prevention of type 2 DM. However, it does significantly improvement in glycemic control of patients taking ramipril for currently accepted indications (Hypetension, CCF, High risk cardiac events). [Ref. N Engl J Med 10.1056/nejm/e068213 : Among persons with impaired fasting glucose levels or impairedglucose tolerance, the use of ramipril for 3 years does notsignificantly reduce the incidence of diabetes or death but does significantly increase regression to normoglycemia. (ClinicalTrials.govnumber, NCT00095654.)]

NEJM this week

2006-08-31T09:07:00.000-04:00

This week in NEJM: (Aug 31, 2006)

1. Celecoxib and Prevention of Colorectal Adenomatous Polyps

2. RCT of Deep-Brain Stimulation for Parkinson's Disease

3. Medical Progress: Cerebral Aneurysms

4.Becoming a Physician: Primary Care — The Best Job in Medicine?

US top medical graduate medical schools

2006-08-18T13:23:00.000-04:00

Here it is:
US best medical schools and hospitals by U.S. News
Top Medical Schools - Research

Again, my favourite is at 9th!

P.S.: I am unable to update MATCH 2007 related updates at SBAmin.com /usmle because of heavy rains and hardware problems with my PC:-( I suggest Digital Doc blog s for interesting and rich information on match 2007 applicants.
--

Topics to watch for in Clinical Medicine

2006-07-12T18:25:00.000-04:00

1. Transmission of Mycobacterium tuberculosis from Health Care Workers, esp. foreign health workers in US
    NEJM 2006;355:118-121 [ CDC relevant guideline link]

2. Aphthous Ulceration
    NEJM 2006;355:165-172

3. Parkinson's Patients Helped By Neurologists With Expertise In Brain Stimulation Therapy
    Medical News today
Patients with Parkinson's disease who are undergoing a treatment known as deep brain stimulation may benefit from the direct involvement of a neurologist with expertise both in movement disorders and in deep brain stimulation, according to an article posted online today that will appear in the September 2006 print issue of Archives of Neurology.

4. Gaining Weight After Menopause Raises Breast Cancer Risk
    Medical News Today
A woman who gains weight after the menopause raises her risk of developing breast cancer, while a woman who loses weight after the menopause lowers her risk, say researchers from Harvard Medical School and the Harvard School of Public Health, USA. You can read about this study in the Journal of the American Medical Association (JAMA).The researchers monitored 49,514 women for up to 24 years.

And finally, if you are taking naps on call duty, it's OK!
5. Study shows naps improve residents' alertness on call
   American Medical News(AMA member access only)
--
11 July 2006 1820 -0400
CT USA

Inhaled Insulin: Finally it's in market from this July

2006-06-29T18:33:00.000-04:00

Something that I missed to post earlier.

EXUBERA^® (insulin human [rDNA origin]) Inhalation Powder: First of its kind which is approved by FDA for DM management. Check out monograph at http://www.exubera.com/
However, there are some drawbacks of this formulation: bioavailability, glucose control,etc. Check them out via PubMed or I may post after July 1.
--
29 June 2006 1823 -0400
GA
--

Stem becoming stronger

2006-06-20T23:18:00.000-04:00

Watch out for June 26 issue of the Annals of Neurology to know how embryonic stem cells would be the hope for crippling paralysis cure? A Hopkins study performed in rat paralysed (LMN type) with virus infection and subsequent partial recovery with modified embryoinc stem cells placement in spinal cord.....

June 20, 2006 2311 -0400
CT
"Stem cell is the future in medicine,the near future!"
--

ACCP revised guidelines on Cough Diagnosis and Management

2006-06-19T21:57:00.000-04:00

Managing notorious cough: Refer to following link for ACCP revised guidelines on Cough Diagnosis and Management:

An Empiric Integrative Approach to the Management of Cough: ACCP Evidence-based Clinical Practice Guidelines
Original ACCP Supplement
Individual links according to cough etiology are given below under NGC headings

--

---------- Forwarded message ----------
From: NGC < mail@guideline.gov>
Date: Jun 19, 2006 3:21 PM
Subject: NGC Update Service: June 19, 2006

What's New This Week

June 19, 2006

The following new information was posted to the NGC Web site the week of June 19, 2006.

American College of Chest Physicians

An empiric integrative approach to the management of cough: ACCP evidence-based clinical practice guidelines.

Angiotensin-converting enzyme inhibitor-induced cough: ACCP evidence-based clinical practice guidelines.

Chronic cough due to acute bronchitis: ACCP evidence-based clinical practice guidelines.

Chronic cough due to asthma: ACCP evidence-based clinical practice guidelines.

Chronic cough due to bronchiectasis: ACCP evidence-based clinical practice guidelines.

Chronic cough due to chronic bronchitis: ACCP evidence-based clinical practice guidelines.

Chronic cough due to chronic interstitial pulmonary diseases: ACCP evidence-based clinical practice guidelines.

Chronic cough due to gastroesophageal reflux disease: ACCP evidence-based clinical practice guidelines.

Chronic cough due to lung tumors: ACCP evidence-based clinical practice guidelines.

Chronic cough due to nonasthmatic eosinophilic bronchitis: ACCP evidence-based clinical practice guidelines.

Chronic cough due to nonbronchiectatic suppurative airway disease (bronchiolitis): ACCP evidence-based clinical practice guidelines.

Chronic cough due to tuberculosis and other infections: ACCP evidence-based clinical practice guidelines.

Chronic upper airway cough syndrome secondary to rhinosinus diseases (previously referred to as postnasal drip syndrome): ACCP evidence-based clinical practice guidelines.

Cough and aspiration of food and liquids due to oral-pharyngeal dysphagia: ACCP evidence-based clinical practice guidelines.

Cough and the common cold: ACCP evidence-based clinical practice guidelines.

Cough in the immunocompromised host: ACCP evidence-based clinical practice guidelines.

Cough suppressant and pharmacologic protussive therapy: ACCP evidence-based clinical practice guidelines.

Cough: occupational and environmental considerations: ACCP evidence-based clinical practice guidelines.

Guidelines for evaluating chronic cough in pediatrics: ACCP evidence-based clinical practice guidelines.

Habit cough, tic cough, and psychogenic cough in adult and pediatric populations: ACCP evidence-based clinical practice guidelines.

Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines.

Peritoneal dialysis and cough: ACCP evidence-based clinical practice guidelines.

Postinfectious cough: ACCP evidence-based clinical practice guidelines.

Uncommon causes of cough: ACCP evidence-based clinical practice guidelines.

Unexplained (idiopathic) cough: ACCP evidence-based clinical practice guidelines.

PPB case updated - 7 June 2006

2006-06-07T01:53:00.000-04:00

Case report on Pleuro Pulmonary Blastoma is updated. Details are available at www.SBAmin.com/case/ppb.htm

Thanks!

SBA
--

Cervical cancer vaccine: Coming Soon

2006-05-19T14:29:00.000-04:00

A Food and Drug Administration advisory committee voted 13-0 to endorse the safety and effectiveness of Merck and Co.'s GARDASIL(r) (Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine) which is so far tested in more than 27,000 females and males at Whitehouse Station, N.J. hub of Merck Inc. According to Merck, the vaccine could be used in females age 9 to 26, but would work best when given to girls before they begin having sex. Final decision on vaccine approval and vaccination strategy is expected in June 2006.

[Link]

Track relevant updates at:

Cyanide Antidote Regime

2006-04-17T10:18:00.000-04:00

Managing Cyanide Poisoning: Click here to view flyer
--
Image source

Images in Medicine & MedWatch(FDA) Alert

2006-04-13T10:05:00.000-04:00

Pseudoclubbing N Engl J Med 354:15 April 13, 2006
Video instruction Placement of an Arterial Line N Engl J Med 354:15 April 13, 2006
FDA MedWatch Alert ! (11 April, 2006): Increased Incidence of Serious Fungal Infection with Soft Contact Lenses

Leptin in Human Reproduction

2006-04-03T10:20:00.000-04:00

Novel Hormones - LEPTIN IN HUMAN REPRODUCTION, read detailed article here
--

RISUG trial back on the track after 2 yr halt

2006-03-30T11:21:00.000-05:00

HAPPY DOCTORS DAY (MARCH 30)

Male Contraceptive Method:

RISUG (Reversible Inhibition of Sperm Under Guidance): a reversible, nonhormonal contraceptive that provides 10 or more years of protection after a 10-15 minute procedure. Researchers received approval this week to begin enrolling additional study volunteers, after a delay of nearly four years. In the RISUG study, doctors inject a gel into the tube that sperm travel through after they are produced (known as the vas deferens). The gel then disables the sperm as they swim by. In study animals, male fertility returns if the RISUG is flushed out with another injection that dissolves the gel.
In 2002, when enrollment in the Indian study was halted, more than 140 men were already using RISUG. Concern about side effects and insufficiency of safety data caused a temporary suspension of the project. However, expert panels subsequently concluded that the major side effect -- several weeks of non-painful scrotal swelling in about a third of the subjects --was not enough to stop the study.
Currently, RISUG's developers (ICMR, India and affiliated researchers) are arranging a collaboration with US researchers. Lissner says that to gain FDA approval, US researchers will have to begin with animal tests, so studies in North American men would not start for several years.
.....
Abstract from EurekAlert! 30 March 2006 post
--
Other useful links on current research in contraception:
http://www.malecontraceptives.org/methods/risug.php
http://www.mcip.info/
--

Updated clinical guidelines

2006-03-28T11:17:00.000-05:00

Recently Updated Clinical Guidelines at National Guideline Clearinghouse (NGC):

March 27, 2006

1. Anakinra for rheumatoid arthritis

MAJOR RECOMMENDATIONS

On the balance of its clinical benefits and cost effectiveness, anakinra is not recommended for the treatment of rheumatoid arthritis, except in the context of a controlled, long-term clinical study.
Patients currently receiving anakinra for rheumatoid arthritis may suffer loss of well-being if their treatment were discontinued at a time they did not anticipate. Therefore, patients should continue therapy with anakinra until they and their consultant consider it is appropriate to stop.

2. Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis

MAJOR RECOMMENDATIONS

Combination therapy with peginterferon alfa and ribavirin is recommended within its licensed indications for the treatment of people aged 18 years and over with moderate to severe chronic hepatitis C (CHC), defined as histological evidence of significant scarring (fibrosis) and/or significant necrotic inflammation.
People with moderate to severe CHC are suitable for treatment if they have:
People currently being treated with interferon alfa, either as combination therapy or monotherapy, may be switched to the corresponding therapy with peginterferon alfa.
Treatment for the groups identified in the first two recommendations (see above) should be as follows.
People satisfying the conditions in the first two recommendations (see above) but for whom ribavirin is contraindicated or is not tolerated should be treated with peginterferon alfa monotherapy. Regardless of genotype, individuals should be tested for viral load at 12 weeks, and if the viral load has reduced to less than 1% of its level at the start of treatment, treatment should be continued for a total of 48 weeks. If viral load has not fallen to this extent, treatment should stop at 12 weeks.
People for whom liver biopsy poses a substantial risk (such as those with haemophilia, or those who have experienced an adverse event after undergoing a previous liver biopsy), and people with symptoms of extra-hepatic HCV infection sufficient to impair quality of life, may be treated on clinical grounds without prior histological classification.
There is insufficient evidence to recommend combination therapy using peginterferon alfa or interferon alfa in people who:

3. Guidance on the use of liquid-based cytology for cervical screening

4. Myocardial perfusion scintigraphy for the diagnosis and management of angina and myocardial infarction

5. British guideline on the management of asthma. A clinical national guideline This updates a previously published guideline summary.

ALERT! mifepristone & sepsis risk

2006-03-22T10:12:00.000-05:00

FDA MedWatch announced alert on March 17, 2006 for proper prescription and follow up of women who are prescribed mifepristone for medical abortion following two newly reported cases of death from sepsis following medical abortion with mifepristone and misoprostol. FDA urges in particular, physicians and their patients should fully discuss early potential signs and symptoms that may warrant immediate medical evaluation. Previously reported four cases of death from sepsis were because of Clostridium sordellii sepsis.
Currently approved regime for medical abortion by FDA is as follows^#:

The approved Mifeprex regimen for a medical abortion through 49 days' pregnancy is:

Day One: Mifeprex Administration: 3 tablets of 200 mg of Mifeprex orally at once
Day Three: Misoprostol Administration: 2 tablets of 200 mcg of misoprostol orally at once.
Day 14: Post-Treatment: the patient must return to confirm that a complete termination has occurred. If not, surgical termination is recommended to manage medical abortion treatment failures.
The safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intravaginally, has not been established by the FDA.

This post has partial summary from FDA website.
--
#: It is highly recommended and disclaimed hereby to refer to FDA website links on " Mifeprex (mifepristone) Information & Sepsis and Medical abortion update: Public Health Advisory" for up-to-date, complete and authentic information on given blog post. For complete disclosure/disclaimer details, click here.
--
P.S.: NEJM article on Fatal Toxic Shock Syndrome Associated with Clostridium sordellii after Medical Abortion: Four case reports
N Eng J Med 2005;353:2352-2360
--

Hope for Huntington's Disease patients

2006-03-20T12:03:00.000-05:00

FK506 (Tacrolimus): Hope for Huntington's Disease (HD) patients

01 Feb 2006

Researchers are working at Institut Curie and other labs to find out role of Tacrolimus (Immunosupressant) in preventing mutant Huntingtin protein's cumulative toxicity to neurons and thereby giving ray of hope to many patients with currently incurable HD. Read more at....
Title: Inhibition of Calcineurin by FK506 Protects against Polyglutamine-Huntingtin Toxicity through an Increase of Huntingtin Phosphorylation at S421: Abstract of February 1, 2006 issue of The Journal of Neuroscience
--

Online manuals for ACLS providers

2006-03-20T11:13:00.000-05:00

Here are NGC redirected links for ACLS providers to refresh their skills and theory base from AHA journal.

From American Heart Association

Acute coronary syndromes: 2005 International Consensus Conference on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations.

Adult basic life support: 2005 International Consensus Conference on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations.

Advanced life support: 2005 International Consensus Conference on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations.

Defibrillation: 2005 International Consensus Conference on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations.

First aid: 2005 International Consensus Conference on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations.

Managing abnormal blood lipids. A collaborative approach.

Neonatal resuscitation: 2005 International Consensus Conference on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations.

Pediatric basic and advanced life support: 2005 International Consensus Conference on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations.

Stroke: 2005 International Consensus Conference on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations.

--
SBA

Rituximab to be studied for the role in preserving Insulin store in early Type 1 DM

2006-03-16T10:44:00.000-05:00

Rituximab to be studied for the role in preserving Insulin store in early Type 1 DM
16-Mar-2006

Rituximab (Rituxan® and MabThera®) - a monoclonal antibody against CD-20 B Cells will be studied in this April to evalauate its possible role in halting progression auto-immune destruction of beta islets of pancreas seen in early pathogenesis of Type 1 DM. The study will test rituximab in recently diagnosed type 1 diabetes patients who are at least 8 years old and who still have some pancreas function. The patients will receive treatments once a week for four weeks. Two-thirds of the participating patients will receive rituximab, and the rest will receive a placebo. Being an international research trial, Indiana University School of Medicine scientists will begin the study and will enroll 66 patients over two years. The study is funded by TrialNet, a National Institute of Health, federally-funded research initiative.
Original link EurekAlert!
--

sirolimus-eluting stent is superior to vascular brachytherapy in-stent restenosis following bare-metal stent placement

2006-03-12T12:25:00.000-05:00

Study performed at Mayo Clinic, Rochester, Minn. shown sirolimus-eluting stent is superior to vascular brachytherapy in-stent restenosis following bare-metal stent placement. Read early release article at JAMA. 2006;295:1264-1273 [Abstract at EurekAlert!]

--
SBA

Top ten contact dermatitis allergens identified in Mayo Clinic study

2006-03-05T11:44:00.000-05:00

Top ten contact dermatitis allergens identified in Mayo Clinic study

Original Article at EurekAlert!

Research also confirms utility of patch testing to discover allergens and finds patients satisfied with testing, yet they recall only half of their allergens

A new Mayo Clinic study reveals the most common causes of allergic contact dermatitis, a skin inflammation resulting in swollen, reddened and itchy skin due to direct contact with an allergen. Topping the list were:

Nickel (nickel sulfate hexahydrate) -- metal frequently encountered in jewelry and clasps or buttons on clothing
Gold (gold sodium thiosulfate) -- precious metal often found in jewelry
Balsam of Peru (myroxylon pereirae) -- a fragrance used in perfumes and skin lotions, derived from tree resin
Thimerosal -- a mercury compound used in local antiseptics and in vaccines
Neomycin sulfate -- a topical antibiotic common in first aid creams and ointments, also found occasionally in cosmetics, deodorant, soap and pet food
Fragrance mix -- a group of the eight most common fragrance allergens found in foods, cosmetic products, insecticides, antiseptics, soaps, perfumes and dental products
Formaldehyde -- a preservative with multiple uses, e.g., in paper products, paints, medications, household cleaners, cosmetic products and fabric finishes
Cobalt chloride -- metal found in medical products; hair dye; antiperspirant; objects plated in metal such as snaps, buttons or tools; and in cobalt blue pigment
Bacitracin -- a topical antibiotic
Quaternium 15 -- preservative found in cosmetic products such as self-tanners, shampoo, nail polish and sunscreen or in industrial products such as polishes, paints and waxes

Read original and full article at EurekAlert!
--

Pleuro Pulmonary Blastoma (PPB) case updated

2006-02-25T13:23:00.000-05:00

Case report on Pleuro Pulmonary Blastoma is updated. However, access to PPB case is now password protected to avoid pre-mature and partial release of case details untill we finalize the case report and submit it to medical journal. Physicians who are really interested in this case are welcomed to contact SBAmin to share their views and discuss on PPB.

Thanks!

SBA

Feb 25, 2006 2344 +0530

Baroda, India
--
"Nanavaptam avaptavyam varta eva ca karmani" : The God says to Arjuna : Nor I am in want of anything, nor have I need to obtain anything--and yet I am engaged in work. [The Bhagavad Gita - 3.22 @ http://www.asitis.com]

First diagnostic markers for ALS ; Aspirin dose for MI and Stroke?

2006-02-22T13:04:00.000-05:00

First diagnostic indicator for Amytrophic Lateral Sclerosis (ALS) identified

Mount Sinai School of Medicine researchers have identified three proteins that may be first tools for confirming diagnosis of ALS

Published in this month's issue of Neurology.

Researchers from Mount Sinai School of Medicine identified three proteins that are found in significantly lower concentration in the cerebral spinal fluid of patients with ALS than in healthy individuals. These are the first biomarkers for this disease .

"ALS is a very difficult disease to diagnose. To date, there is no one test or procedure to ultimately establish the diagnosis of ALS. It is through a clinical examination and series of diagnostic tests, often ruling out other diseases," website of the ALS Association.

Giulio Pasinetti, MD, PhD, Professor of Psychiatry, Neuroscience, and Geriatrics and Adult Development, Mount Sinai School of Medicine and colleagues compared cerebral spinal fluid from patients diagnosed with ALS, patients with other neurological disorders, and healthy individuals. They found that fluid from patients with ALS had significantly lower concentrations of three proteins than either of the other groups. Evaluating the levels of these three proteins proved 95% accurate for diagnosing ALS.

The researchers found that the changes in concentration of these proteins were evident within 1.5 years of onset of symptoms. With current methods, the average time from onset of symptoms to diagnosis is two years . Testing for these protein concentrations may provide a means of early diagnosis, allowing patients to receive relief from symptoms years earlier...

Original article at EurekAlert!

Aspirin to Prevent Heart Attack and Stroke: What's the Right Dose?

James E. Dalen MD, MPH

Professor Emeritus, University of Arizona, Tucson

Available online 20 February 2006

The American Journal of Medicine
Volume 119, Issue 3 , March 2006, Pages 198-202

Abstract

Despite hundreds of clinical trials, the appropriate dose of aspirin to prevent myocardial infarction (MI) and stroke is uncertain. In the US, the doses most frequently recommended are 80, 160, or 325 mg per day. Because aspirin can cause major bleeding, the appropriate dose is the lowest dose that is effective in preventing both MI and stroke because these two diseases frequently co-exist. Five randomized clinical trials have compared aspirin with placebo or no therapy for the prevention of stroke and MI. These trials varied with regard to the dose of aspirin, the duration of treatment, and, most important, the populations selected for study varied in their baseline risk of stroke and MI. In men, 160 mg/day consistently lowered the risk of MI. In women, doses of 50 mg, 75, and 100 mg/day did not significantly decrease the risk of MI; therefore, the appropriate dose in women must exceed 100 mg/day. The appropriate dose for the primary prevention of stroke in men and women has not been established. Doses of 75 and 100 mg/day have been ineffective in men and women. The appropriate dose must be at least 160 mg/day. The lowest dose to prevent recurrent MI or death in patients with stable coronary artery disease (CAD) is 75 mg/day. In acute MI the lowest dose is 160 mg/day. In patients with a history of stroke or transient ischemic attack (TIA), 50 mg/day has been shown to be effective in men and women. In acute stroke, 160 mg/day is effective in preventing recurrent stroke or death. The risk of major bleeding with 160 mg/day is the same as with 80 mg/day: 1 to 2 cases per 1000 patient years of treatment, and the risk of fatal bleeding is the same with 80 and 160 mg/day. These studies indicate that the most appropriate dose for the primary and secondary prevention of stroke and MI is 160 mg/day.

Fwd: Calcium doens't prevent postmenopausal fractures contrary to popular opinion

2006-02-19T05:11:00.000-05:00

---------- Forwarded message ----------
From: Dr. Maulik Baxi
Date: Feb 19, 2006 12:12 AM
Subject: Calcium doens't prevent postmenopausal fractures contrary to popular opinion
To: SBA

Hi!

Please go through this excellent clinical data, study lasting over 7 years in about 36000 patients gives significant and sufficient data to prove that there is no role of calcium in preventing post-menopausal fractures. On the contrary, it significantly increases incidence of renal calculi.

I think this is sufficient evidence to stop prescribing calcium tablets haphazardly to each and every patient that comes across. Active weight bearing still holds the key and such exercises need to be advised more frequently than calcium as preventive measure.

The article doesn't touch area of fracture healing and more evidence is needed to support or refute if calcium supplements help in expediting fracture healing. Therefore in cases of traumatic fractures calcium supplementation might be needed.

In case of pathological fractures, each and every case merits individualized attention according to underlying pathology.

I seek comments and guidance of my seniors on this issue. Apparently not an issue of life and death but still important in day-to-day clinical practice. I'd be grateful if you could throw some light.

Thank you.
Maulik

********************************************************************************************************************************************************
Read the abstract here. For complete article go to http://content.nejm.org/cgi/content/full/354/7/669

ABSTRACT

Background The efficacy of calcium with vitamin D supplementationfor preventing hip and other fractures in healthy postmenopausalwomen remains equivocal.

Methods We recruited 36,282 postmenopausal women, 50 to 79 yearsof age, who were already enrolled in a Women's Health Initiative(WHI) clinical trial. We randomly assigned participants to receive 1000 mg of elemental calcium as calcium carbonate with 400 IUof vitamin D₃ daily or placebo. Fractures were ascertained foran average follow-up period of 7.0 years. Bone density was measured at three WHI centers.

Results Hip bone density was 1.06 percent higher in the calciumplus vitamin D group than in the placebo group (P<0.01).Intention-to-treat analysis indicated that participants receiving calcium plus vitamin D supplementation had a hazard ratio of0.88 for hip fracture (95 percent confidence interval, 0.72to 1.08), 0.90 for clinical spine fracture (0.74 to 1.10), and0.96 for total fractures (0.91 to 1.02). The risk of renal calculiincreased with calcium plus vitamin D (hazard ratio, 1.17; 95percent confidence interval, 1.02 to 1.34). Censoring data from women when they ceased to adhere to the study medication reducedthe hazard ratio for hip fracture to 0.71 (95 percent confidenceinterval, 0.52 to 0.97). Effects did not vary significantly according to prerandomization serum vitamin D levels.

Conclusions Among healthy postmenopausal women, calcium withvitamin D supplementation resulted in a small but significantimprovement in hip bone density, did not significantly reducehip fracture, and increased the risk of kidney stones. ( ClinicalTrials.govnumber, NCT00000611 [ClinicalTrials.gov] .)
--
Maulik Baxi, MBBS
Baroda, India

+91-982-541-6408
maulik_baxi@rediffmail.com

--
"Nanavaptam avaptavyam varta eva ca karmani" : The God says to Arjuna : Nor I am in want of anything, nor have I need to obtain anything--and yet I am engaged in work. [The Bhagavad Gita - 3.22 @ http://www.asitis.com]

Don't be panic to your stuttering kid

2006-02-16T14:56:00.000-05:00

Parents should not pressurise their child to speak in a slow and clear manner as it will make child feel that he/she may have a problem of stuttering and may affect his/her further developmental progress. Read article of Professor Goetz Schade, who is the head of the Phoniatrics and Paedaudology Section of Bonn's University Clinic. (EurekAlert!)
--

2005-05-13T09:17:00.000-04:00

Visit Blog Center @ SBAmin.com ( http://bloglines.com/public/samblog ) for all medical and other updates..Find out latest journal articles from BMJ, Medscape,etc.
Thanks

SBAmin.com is unplugged till Dec 30 2004

2004-11-20T02:55:00.000-05:00

SBAmin.com will not be updated (Including SamBLOG) till December 30 2004 because of my USMLEÂ Step 1 exam. I may not able to respond to your emails meanwhile. For unavoidable conditions !, contact me on my cell no. 0091 93762 26975. Regret for the same & revisit SBAmin.com after Dec 30 2004.

Dr.Samir B. Amin

Nov 20 2004 Baroda India

Cell : 0091 93762 26975

Attention : My New Cell No. is 0091 93762 26975

2004-10-26T12:33:00.000-04:00

MY CELL NO.(0091 265 3126975) IS CHANGED, NEW NO. IS 0091 93762 26975 (RIM)

Dr.Samir B. Amin Baroda India www.SBAmin.com

Do you Yahoo!?
Yahoo! Mail - You care about security. So do we.

FOR CLASSMATES ONLY : Join Acharya Mihir Batch ( AMJ Batch Online) Group Now !

2004-10-11T15:54:00.000-04:00

Dear Classmates of Mihir J. Acharya Batch (AMJ Batch Online),

To Join the group, click http://groups.yahoo.com/group/amjbatch/join

We will surely miss you all a lot. On the eve of our final day of internship, we would like to invite you ALL to JOIN our online presence at our group website : http://groups.yahoo.com/group/amjbatch which is created to stay connected among batch mates. This online group will keep a record of out details so that in the far future one can access details about individual classmate's information : i.e. : Where are we? In which residency we have joined? How to contact ? etc.

The group details can be accessed by our classmates ONLY

To Join the group, click http://groups.yahoo.com/group/amjbatch/join

Kindly support our humble initiative !

Thanks for co-operation

Moderators,

AMJ Batch Online

Medical College & SSG Hospital, Baroda (Vadodara) , India

Quick Address : www.SBAmin.com/group/amj

__________________________________________________
Do You Yahoo!?
Tired of spam? Yahoo! Mail has the best spam protection around
http://mail.yahoo.com

2004-10-04T05:52:00.000-04:00

Medical Alert

Merck Announces Voluntary Worldwide Withdrawal of VIOXXÂ® - Rofecoxib

Extracts.....

On Sept. 30, 2004, Merck &. Co., Inc. announced a voluntary worldwide withdrawal of VIOXXÂ® (rofecoxib) - a highly selective COX-2 inhibitor.

The company's decision, which is effective immediately, is based on new, three-year data from a prospective, randomized, placebo-controlled clinical trial, the APPROVe (Adenomatous Polyp Prevention on VIOXX) trial. APPROVe - a clinical trial which is being stopped, was a multi-center, randomized, placebo-controlled, double-blind study to determine the effect of 156 weeks (three years) of treatment with VIOXX on the recurrence of neoplastic polyps of the large bowel in patients with a history of colorectal adenoma. The trial enrolled 2,600 patients and compared VIOXX 25 mg to placebo. The trial began enrollment in 2000. In this study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking VIOXX compared to those taking placebo.....

Further information for medical professionals :

1. Press note by Merck Inc.

2. VIOXXÂ® Website

3. PubMedÂ® PMID: 15151474 & Related Articles

4. Merck Inc.

VIOXXÂ® (rofecoxib) is a registered trademark of Merck & Co., Inc.

PubmedÂ® is the registered symbol by U.S. National Library of Medicine (NLM)

POSTED BY SBAmin.com FOR MEDICAL PROFESSIONALS ONLY

Disclosure/Disclaimer details

*END*

Top 10 Medical Schools in USA #

2004-09-22T02:08:00.000-04:00

Top 10 Medical Schools in USA #

1. Harvard University

2. Johns Hopkins University

3. Washington University in St. Louis

4. Duke University

5. University of Pennsylvania

6. University of California San Francisco

7. Columbia U. College of Physicians and Surgeons

8. Stanford University

9. University of Michigan Ann Arbor

10. Yale University

# Disclaimer : Based on personal assumption of Dr. Samir B. Amin
(SBAmin.com). No ideal methodology was performed to rank these schools.
Gradings may differ in reality. I personally advise & disclose not to
make any sort of inference from above ranking.

Original compilation by MP

Dr.Samir B.Amin
September 22 2004 10:45 +0530 Baroda(Ind ia)
www.SBAmin.com

Sorry ! No More Updates Till Futher Notice

2004-09-17T09:23:00.000-04:00

No further update will be posted on website www.SBAmin.com OR its related web blogs and message boards till further notice because of upcoming USMLEÂ Step 1 Exam of site administrator.

For any query, contact at www.SBAmin.com/main/contact (Kindly send Instant email OR Conventional email from there). Regret for inconvenience.

Sep 17 2004 18:51 +0530 Baroda India

This week In NEJM September 16, 2004 www.nejm.org

2004-09-16T04:20:00.000-04:00

http://content.nejm.org/content/vol351/issue12/index.shtml

Changing the Cell Source in Cell Therapy?
G. Pellegrini
Catheter Ablation for Cardiac Arrhythmias
H. J.J. Wellens
Becoming a Physician: Match Point?
A. A. Wright and I. T. Katz
Current Concepts: Cystic Neoplasms of the Pancreas
W. R. Brugge and Others
Medical Progress: Turner's Syndrome
V. P. Sybert and E. McCauley
Case 29-2004 Â A 75-Year-Old Woman with Acute Onset of Chest Pain Followed by Fever
A. W. Karchmer and Others
Traumatic Laceration of the Aorta
F. B. Rogers

Dr Samir B. Amin Baroda India www.SBAmin.com

This Week in BMJ : 11 September 2004 www.bmj.com

2004-09-15T07:02:00.000-04:00

1. Parkinson's disease: a journey
Kamran Abbasi
http://bmj.com/cgi/content/full/329/7466/0-h?etoc

2. Using monoamine oxidase type B inhibitors in Parkinson's disease
Yoav Ben-Shlomo and Kailash Bhatia
http://bmj.com/cgi/content/full/329/7466/581?etoc

3. Computers may facilitate assessment of medical students
http://bmj.com/cgi/content/full/329/7466/0-e?etoc

4. Using computers for assessment in medicine
Peter Cantillon, Bill Irish, David Sales
http://bmj.com/cgi/content/full/329/7466/606?etoc

5. Polypill will not change prevention of heart disease
Susan Mayor
http://bmj.com/cgi/content/full/329/7466/589-a?etoc

Alumni Contacts for Baroda Medical College & SSG Hopsital Students/Graduates , Vadodara , India

2004-09-09T05:38:00.000-04:00

Baroda Medical College Alumni Association - BMCAA www.bmcaa.org

Alumni Association of Medical College Vadodara & Shree Sayajirao Gaekwad Genral Hospital (SSG Hospital) , Baroda India : Homepage at www.bmcaa.org

American Association of the Physicians of Indian Origin (AAPI) at http://www.aapiusa.net

American Association of the Physicians of Indian Origin (AAPI) - Medical Students & Residents Home at http://www.aapimsr.org

__________________________________________________
Do You Yahoo!?
Tired of spam? Yahoo! Mail has the best spam protection around
http://mail.yahoo.com

Happy Teachers' Day

2004-09-04T15:52:00.000-04:00

The mediocre teacher tells. The good teacher explains. The superior teacher demonstrates. The great teacher inspires.

-William Arthur Ward

HAPPY TEACHERS' DAY

__________________________________________________
Do You Yahoo!?
Tired of spam? Yahoo! Mail has the best spam protection around
http://mail.yahoo.com

BMJ Articles of Interest at bmj.com

2004-09-03T17:34:00.000-04:00

Bell's palsy responds best to immediate treatment
http://bmj.com/cgi/content/full/329/7465/0-e?etoc

Recent developments in Bell's palsy
N Julian Holland and Graeme M Weiner
http://bmj.com/cgi/content/full/329/7465/553?etoc

Preventing the spread of MRSA
Andreas Voss
http://bmj.com/cgi/content/full/329/7465/521?etoc

Treating hypertension with guidelines in general practice
Neil C Campbell and Peter Murchie
http://bmj.com/cgi/content/full/329/7465/523?etoc

Study indicates nine risk factors explain most heart attacks
Caroline White
http://bmj.com/cgi/content/full/329/7465/527?etoc

Bioterrorism and compulsory vaccination
Tom Jefferson
http://bmj.com/cgi/content/full/329/7465/524?etoc

Drinking no alcohol, or too much, increases the risk of cognitive
impairment
http://bmj.com/cgi/content/full/329/7465/0-b?etoc

This Week In NEJM at http://www.nejm.org

2004-09-02T17:11:00.000-04:00

This Week In NEJM at http://www.nejm.org

Medical Progress: Management of Cutaneous Melanoma
H. Tsao and Others

SIDS Â A Syndrome in Search of a Cause
M.H. Malloy

Body Fat, Leptin, and Hypothalamic Amenorrhea
R.S. Ahima

Tamoxifen with or without Breast Irradiation in Women 50 Years of Age or Older with Early Breast Cancer
A.W. Fyles and Others

Detection of Liver Abscesses by T₁-Weighted Magnetic Resonance Imaging
M. Nakagawara and Others

Homocysteine as a Predictive Factor for Hip Fracture in Older Persons

Do you Yahoo!?
Y! Messenger - Communicate in real time. Download now.

BMJ : This week's articles of interest

2004-08-27T05:05:00.000-04:00

This Week in BMJ at www.bmj.com

To scan or not to scan in headache
Peter J Goadsby
http://bmj.com/cgi/content/full/329/7464/469?etoc

Is good cholesterol always good?
Gilbert R Thompson
http://bmj.com/cgi/content/full/329/7464/471?etoc

Meet Rudy, the world's first "robodoc"
Roger Dobson
http://bmj.com/cgi/content/full/329/7464/474-b?etoc

Research Article : Corticosteroids for severe sepsis and septic shock: a systematic review and meta-analysis
Djillali Annane, Eric Bellissant, Pierre Edouard Bollaert, Josef Briegel,
Didier Keh, Yizhak Kupfer
http://bmj.com/cgi/content/full/329/7464/480?etoc

Updated : Deadline for USMLE 2004 Applications

2004-08-26T09:06:00.000-04:00

According to recent ECFMG Reporter, the deadline for receipt of........

2004 applications for Step 1 and Step 2 CK is August 31, 2004.

However, for 2004 Step 2 CS applications, the deadline for receipt has been extended to September 30, 2004.

Important deadlines for those submitting online application (IWA)Â for USMLE STEP 1 / STEP 2 CK are just posted at ECFMG Website. You should visit ECFMG official announcement at http://ecfmg.org/news/aug2604.htmlÂ .

2005 USMLE Application Materials & Information Booklet (both paper & online) are expected to be available on the ECFMG website on approximately August 31, 2004. Kindly monitor ECFMG website for the latest updates at http://ecfmg.org

Extracted from The ECFMG Reporter August 26, 2004

USMLE & ECFMG are registered trademarks of their respective owners.

articles at BMJ website

2004-08-06T06:03:00.000-04:00

Important Artilces at BMJ site www.bmj.com 7 August 2004

Clopidogrel may be associated with acquired haemophilia A
http://bmj.com/cgi/content/full/329/7461/0-d?etoc

Efficacy of topical non-steroidal anti-inflammatory drugs in the treatment of osteoarthritis: meta-analysis of randomised controlled trials
Jinying Lin, Weiya Zhang, Adrian Jones, Michael Doherty http://bmj.com/cgi/content/full/329/7461/324?etoc

New perspectives--approaches to medical education at four new UK medical
schools
Amanda Howe, Peter Campion, Judy Searle, Helen Smith
http://bmj.com/cgi/content/full/329/7461/327?etoc

ABC of burns: Rehabilitation after burn injury
Dale Edgar and Megan Brereton
http://bmj.com/cgi/content/full/329/7461/343?etoc

On Friendship Day

2004-08-01T04:35:00.000-04:00

"Friends are the siblings God forgot to give us."

HAPPY FRIENDSHIP DAY

(First Sunday of August)

Do you Yahoo!?
New and Improved Yahoo! Mail - 100MB free storage!

ECFMG Changes to Eligibility Requirements for IMGs

2004-07-30T15:11:00.000-04:00

Very Important Change in eligibility requirements for IMGs taking USMLE 2005 Step 2 CK & Step 2 CS has been introduced by ECFMG. Go to http://ecfmg.org/news/jul3004.html for full announcement.

USA Visas for IMGs resources at SBAmin.com

2004-07-30T10:15:00.000-04:00

USA Visas for IMGs Resources at SBAmin.com - Updated with useful links about types of visas / specific information regarding different types of visas (i.e.: H 1-B, J-1, B-1 & Immigrant Visas).

Visit www.SBAmin.com/main/visa for more

Articles of Interest at BMJ

2004-07-30T10:10:00.000-04:00

This Week in BMJ www.bmj.com

Combination anticoagulation therapy doubles risk of bleeding in patients at
high risk of stroke
Debashis Singh
http://bmj.com/cgi/content/full/329/7460/250-c?etoc

Fine needle aspiration cytology in cancer diagnosis
Derek E Roskell and Ian D Buley
http://bmj.com/cgi/content/full/329/7460/244?etoc

Dronabinol (cannabinoid) has a modest analgesic effect in multiple sclerosis
http://bmj.com/cgi/content/full/329/7460/0-b?etoc

Evidence based case report: Corticosteroids for HELLP (haemolysis, elevated
liver enzymes, low platelets) syndrome
Timothy L Clenney and Anthony J Viera
http://bmj.com/cgi/content/full/329/7460/270?etoc

ABC of burns: Burns reconstruction
Juan P Barret
http://bmj.com/cgi/content/full/329/7460/274?etoc

Medical Portals On the Web

2004-07-28T05:48:00.000-04:00

Log on to very popular Medical Portals for Medical Professionals at
www.Medscape.com and www.eMedicine.com
-----
Dr.Samir B.Amin
www.SBAmin.com

Deadline for 2004 USMLEâ¢ Applications - Aug 31 2004

2004-07-23T16:19:00.000-04:00

The last 2004 eligibility period for Step 1 and Step 2 CK is October
2004 - December 2004. The deadline for ECFMG's receipt of complete
applications for this eligibility period is August 31, 2004.
FOR FULL STORY, Visit ECFMG WEBSITE LINK http://ecfmg.org/news/jul2304.html

Thanks
--
Dr.Samir B.Amin
Baroda(India)
www.SBAmin.com

NEW XML/RSS FEEDS !

2004-07-21T09:21:00.000-04:00

Here are NEW RSS/XML FEED Addresses for SBAmin.com updates:

1. USA VISA for IMGs :

http://usavisa4imgs.blogspot.com/atom.xml

2. Medical College Baroda - Website Devp. Project Updates :

http://mcbonline.blogspot.com/atom.xml

For XML/RSS Support, kindly visit http://www.SBAmin.com/blog/xml.htm
Visit http://bmc.sbamin.com for Medical College Baroda Website Development Team Activities
We value your feedback at http://www.SBAmin.com/signhere

Dr.Samir Amin

What's On BMJ - 17 July 2004; Vol. 329, No. 7458

2004-07-17T01:29:00.000-04:00

Recent Articles at BMJ site www.bmj.com #

15th International AIDS conference: Nevirapine reduces perinatal HIV
transmission in women tested and treated during labour
Susan Mayor
http://bmj.com/cgi/content/full/329/7458/132-b?ecoll
New treatments for colon cancer
Maurice Slevin and Sarah Payne
http://bmj.com/cgi/content/full/329/7458/124?etoc
Threatened miscarriage: evaluation and management
Alexandros Sotiriadis, Stefania Papatheodorou, George Makrydimas
http://bmj.com/cgi/content/full/329/7458/152?etoc
ABC of burns: Management of burn injuries of various depths
Remo Papini
http://bmj.com/cgi/content/full/329/7458/158?etoc
Trends in blood pressure over 10 years in adolescents: analyses of cross
sectional surveys in the Northern Ireland Young Hearts project
David Watkins, Peter McCarron, Liam Murray, Gordon Cran, Colin
Boreham, Paula Robson, Claire McGartland, George Davey Smith, Maurice
Savage
http://bmj.com/cgi/content/abstract/329/7458/139?ecoll
Blood pressure control by home monitoring: meta-analysis of randomised
trials
Francesco P Cappuccio, Sally M Kerry, Lindsay Forbes, Anna Donald
http://bmj.com/cgi/content/abstract/329/7458/145?ecoll
MRSA infections rose by 5% between 2003 and 2004
Caroline White
http://bmj.com/cgi/content/full/329/7458/131-c?etoc

# Disclaimer: Articles are copyrighted by their respective copyright holders (By British Medical Journal in this case). SBAmin.com is not affiliated with the authors of third party links nor responsible for its content mentioned here. This Site is intended for Professional Medical Persons Only. For more visit http://www.sbamin.com/main/contact/disclosure.htm

Dr.Samir Amin Baroda India www.SBAmin.com

NEJM Updates

2004-07-15T11:19:00.000-04:00

Visit http://nejm.org For Following Interesting Articles:
1. Stem Cells - Applications, Bioethics......
2. Antiretroviral agents in Pregnancy-Original Research Articles
3. Management of Deep Vein Thrombosis

--
Dr.Samir B.Amin
Baroda(India)
www.SBAmin.com

NEJM & BMJ: Recent Articles of Interest

2004-07-10T07:02:00.000-04:00

New England Journal of Medicine www.nejm.org 8 July 2004

Editorial: Antiretroviral Agents -- How Best to Protect Infants from HIV and Save Their Mothers from AIDS July 9, 2004
Global Health: The AIDS Epidemic in 2004
R. Steinbrook
Brief Report: Macrolide Resistance in Treponema pallidum in the United States and Ireland
S. A. Lukehart and Others

British Medical Journal Online http://bmj.bmjjournals.com 10 July 2004

1.HIV/AIDS is spreading fastest in eastern Europe and Asia
Deborah Cohen

2.Non-parenteral vaccines

Alain Li Wan Po

Contents copyrighted by their respective copyright organizations

Do you Yahoo!?
Yahoo! Mail - 50x more storage than other providers!

Welcome To MedUpdates @ SBAmin.com

2004-07-08T23:59:00.000-04:00

MedUpdates gives you various internet links of Medical Journal Articles/Conference Summary/CME Links from Medscape,E-Medicine,etc. of latest in Medical Science.

Check out this blog for All Medical Science Related News/Updates/Newer Guidelines/Medical Research

Post your Comments/Suggestions/Questions by clicking "Comments" given at the end of recent post OR simply visit My Message Board

Have A Nice Time !

Dr.Samir Amin
Baroda(Vadodara),India
www.SBAmin.com
Disclaimer:SBAmin.com is not affiliated with the authors of third party links nor responsible for its content mentioned here at http://medupdates.blogspot.com . This Site is intended for Professional Medical Persons Only. For more visit http://www.sbamin.com/main/contact/disclosure.htm