ACC: Tolvaptan Does Not Cut Acute Heart Failure Mortality
Studies show no reduced risk of rehospitalization or death, but significant symptom improvement
MONDAY, March 26 (HealthDay News) -- In patients with acute heart failure, tolvaptan does not reduce the risk of rehospitalization or death, but may improve some symptoms, according to two studies published online March 25 in the Journal of the American Medical Association to coincide with the American College of Cardiology's annual conference in New Orleans.
Both studies are based on the 10-month Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) trials, in which 4,133 patients with acute decompensated heart failure were randomly assigned to receive either tolvaptan or placebo.
Marvin A. Konstam, M.D., of Tufts-New England Medical Center in Boston, and colleagues found no significant group differences in the combined outcome of cardiovascular death or hospitalization for heart failure (42 percent in the tolvaptan group versus 40.2 percent in the placebo group). But they found that the tolvaptan group had significantly greater improvements in body weight, dyspnea and edema.
Mihai Gheorghiade, M.D., of Northwestern University in Chicago, and colleagues observed similar improvements in the tolvaptan group and no group differences in the frequency of serious adverse events.
"These findings would suggest some short-term benefit of tolvaptan on certain acute symptoms of acute decompensated heart failure without evidence of harm, and represent an important contribution for understanding the management of patients with acute decompensated heart failure," states the author of an accompanying editorial.
The study was funded by Otsuka, Inc.