• Cardiology Clinical Trials
• Heart Failure

Results from the EVEREST trial, presented by Marvin A. Konstam, MD, of Tufts-New England Medical Center indicated that in patients with acute decompensated heart failure, tolvaptan, an oral nonpeptide vasopressin V₂-receptor blocker, did not reduce mortality or hospitalizations but did provide modest symptomatic relief.

EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan) consisted of two prospective, randomized, double-blind, placebo-controlled trials at 359 sites in North America, South America, and Europe. The combined study population included 4,133 patients who received 30 mg/day of tolvaptan or placebo within 48 hours of hospital admission. The primary composite endpoint was change from baseline at day 7 or hospital discharge in patient global assessment (by visual analog scale) and body weight. Tolvaptan was associated with additional weight loss of 0.6 kg in one trial and 0.9 kg in the other (p<.0001). There were no significant differences in global clinical status improvement in either trial. A number of secondary endpoints were favorably affected by tolvaptan (Table 1).

The mortality rate for the combined trials was 25.9% for tolvaptan vs 26.3% for placebo-treated patients; the cardiovascular or heart failure hospitalization rate was 42.0% and 40.2%, respectively. The drug was well tolerated with little or no effect on renal function.

Dr. Konstam said that the evidence does not support widespread use of tolvaptan, but the drug could be useful in patients seeking prompt relief of dyspnea, the leading cause of heart failure hospitalizations. “Tolvaptan improved fluid balance with greater weight loss on top of standard background therapy. This was associated with a number of symptomatic benefits as early as day 1, with just one pill,” he said.

• © 2007 MD Conference Express