Heart Failure Trial Halted
PHILADELPHIA (AP) _ The first large-scale study using the heart drug carvedilol in patients with advanced heart failure was halted more than a year early after results showed a significant reduction in the risk of death, researchers said Tuesday.
The preliminary findings could quell long-standing concerns that beta blockers can worsen heart failure.
The ethical committee overseeing the four-year study unanimously agreed that because the risk of death was so drastically reduced, it would be inappropriate for doctors to further withhold treatment, said Milton Packer, the principal investigator of the study and professor of medicine at Columbia University.
The drug, a type of beta blocker, helps reduce the heart’s workload. It is approved only for patients with minor or moderate heart problems.
``The results were so compelling and so large, we believe we could not continue to give people just placebos,″ Packer said.
Final data on the study was not available, but Packer said the specifics will be submitted for approval to the Food and Drug Administration soon.
Heart failure involves a damaged or overworked heart that cannot pump efficiently. It afflicts an estimated 4.8 million Americans and is a leading cause of hospitalization.
Heart failure caused 45,419 deaths in 1997, the latest available figures, according to the American Heart Association.
More than 2,200 patients in over a dozen countries, including Canada, the United Kingdom and France, were involved in the study which began in 1997.
Carvedilol, whose brand name is Coreg, is marketed by SmithKline Beecham, which has its U.S. headquarters in Philadelphia, and Nutley, N.J.-based Hoffman-La Roche Inc.