By Randall Osborne
Hoping to broaden the indications for its lead product, Intercardia Inc. began a 2,000-patient, Phase III study of Bextra (bucindolol HCI), a vasodilating non-selective beta blocker, in Europe.
Dubbed the Bucindolol Evaluation in Acute myocardial infarction Trial, or BEAT, the study will evaluate the drug's ability to prolong survival in patients with reduced left ventricular systolic function within seven days after an acute myocardial infarction (AMI).
Fifteen years ago, researchers believed beta blockers were contraindicated after AMI, because the heart needed adrenaline, which the drugs block, said Bennett Love, spokesman for Intercardia, of Research Triangle Park, N.C. That idea has changed.
"People who had some symptoms, and got into trials anyway, did the best," Love said. "It's becoming more of an accepted treatment."
Another Phase III Bextra study, known as the Beta-blocker Evaluation of Survival Trial, or BEST, began in the U.S. in June 1995. Unlike those in the European trial, eligible patients, with symptoms of congestive heart failure, in that trial must not have had an AMI within six months before enrollment.
David Ward, vice president of research and development for Intercardia, said the two distinct groups allow for a potentially expanded label when the drug is approved.
"There is certainly some overlap in terms of severity of symptoms," he said, but the BEAT study represents a fairly new way to apply beta blockers.
"Nobody has really studied them in the modern era, when there's lots of other drugs floating around," Ward said.
Intercardia is a majority-owned subsidiary of Lexington, Mass.-based Interneuron Pharmaceuticals Inc. The BEAT study will be conducted by BASF AG, of Ludwigshafen, Germany, with which Intercardia has an agreement to share development expenses and operating profits on Bextra outside the U.S. and Japan. *