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BRISTOL-MYERS BUCINDOLOL SHOULD BE CONTINUED FOR CHF

Executive Summary

BRISTOL-MYERS BUCINDOLOL SHOULD BE CONTINUED FOR CHF (congestive heart failure), University of Michigan Cardiology Director Bertram Pitt urged at a May 4 seminar on new drug development. Pointing out that the alpha beta blocker may face a long, and potentially "expensive" clinical development period, Pitt expressed concern that B-M is debating whether to halt further work on the drug. "It would be a shame," Pitt said, if work was not continued on the product. Pitt's primary interest in the product derives from its potential in the treatment of sudden death as well as signs of activity in congestive heart failure. The researcher made his comments at a conference sponsored by "The Pink Sheet" and International Business Communications. Pitt noted "clues" that beta blockers can help prevent sudden death in stabilized congestive heart failure patients. A NIH propranolol vs. placebo study, for example, resulted "in a dramatic almost fifty percent reduction in sudden death" in a subset of patients who had congestive heart failure. Pitt maintained that the prevalence of sudden death in the congestive heart failure mortality trials indicates a major potential for further drug development. "There may be a lot of potential for new research understanding the mechanism and drugs targeted for sudden death," Pitt commented. "I think that if we could do that we might even make some dent here. We certainly have to understand this before we begin major trials looking at mortality because this is going to confound any of the trials that we are going to undertake." Noting the immense popularity of the ACE (angiotensin converting enzyme) inhibitors, Pitt observed that about "45-50% of patients" in a recent ACE study did not show sustained benefit. "That's where there is great potential for pharmaceutical development . . . there is room for other agents in the vasodilator class that perhaps might have a broader spectrum," Pitt said. The Bristol-Myers compound has "alpha blocking properties or maybe some vasodilating properties," Pitt explained. He reported that bucindolol "has been shown [in recent studies] to be very well tolerated in long-term followup (about 21 months). Ejection fraction has been shown to be significantly improved." He acknowledged that the product faces a burden in approval because "so far is that it has not been able to be shown that exercise time has been improved." Patients "are beta blocked, the hemodynamics are improved, but exercise is not improved," Pitt commented.

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