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
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Friday, March 30, 2007
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