Drug Provides Short-Term Relief of Heart Failure Symptoms
But studies of tolvaptan say its use doesn't reduce risk of re-hospitalization or death
SUNDAY, March 25, 2007 (HealthDay News) -- The drug tolvaptan may improve some symptoms and signs of heart failure during hospitalization, but the drug doesn't reduce the risk of re-hospitalization or death, two new studies conclude.
The studies, published in the March 28 issue of the Journal of the American Medical Association, are also being presented at the American College of Cardiology's annual meeting, in New Orleans.
The first study looked at 4,133 hospitalized heart failure patients in Europe, North America and South America who took part in the Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study With Tolvaptan (EVEREST) trial.
The patients received either 30 milligrams of tolvaptan or a placebo once a day for a minimum of 60 days. After 9.9 months, 25.9 percent of the patients taking tolvaptan had died, compared with 26.3 percent of those in the placebo group.
The combined outcome of cardiovascular death or re-hospitalization occurred in 42 percent of the patients taking the drug and in 40.2 percent of the patients who received the placebo. Both groups had similar rates of clinical worsening of heart failure symptoms and of major adverse events.
"Long-term tolvaptan treatment had no effect, either favorable or unfavorable, on all-cause mortality or the combined endpoint of cardiovascular mortality or subsequent hospitalization for worsening HF [heart failure]," the study authors wrote.
The second study of EVEREST trial patients found that the use of tolvaptan in addition to standard therapy provided short-term (up to seven days) relief of some symptoms and signs of heart failure (such as congestion and breathing difficulty) without causing major side effects. The patients received the drug or placebo within 48 hours of admission to hospital.
The EVEREST trial was funded by Otsuka Inc.
The American Heart Association has more about heart failure.