Oral Eltrombopag - A possible answer to Platelet Transfusions

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

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• Eculizumab (Soliris) for paroxysmal nocturnal hemoglobinuria | On this blog
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• Improvements in Haemophilia Therapies

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Rosiglitazone update and Clinical Practice Guidelines: Type 2 DM

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)
  
  

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