Study stopped early due to survival benefit

A major international study of carvedilol (sold under the name Coreg, manufactured by Hoffman-LaRoche in Basel, Switzerland) in patients with advanced chronic heart failure has been stopped early by its steering committee due to a significant survival benefit seen with the drug. Based on the size and consistency of the mortality benefit seen in the trial, known as Copernicus (Carvedilol Prospective Randomized Cumulative Survival Trial), the committee believed it would be inappropriate for physicians to further withhold treatment with the drug.

Copernicus enrolled more than 2,200 patients in 21 countries with advanced heart failure who had symptoms at rest or on minimal exertion but who did not require hospitalization in the intensive care unit or intravenous drug support.

Half the patients received Coreg, and half received a placebo, which were both added to the heart failure medications the patients were already taking. The mortality rate in the Coreg group was significantly lower than in the pla-cebo group, and serious adverse effects were more common in the placebo group. The data from the study will be submitted to the U.S. Food and Drug Administration for review.