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Study: Identical Doses of BiDil Components Are Not Bioequivalent to,the Fixed Dose Combination-BiDil-Used in A-HeFT

NEW ORLEANS, La.--(BUSINESS WIRE)--Mar 26, 2007 - A study comparing the formulations of isosorbide dinitrate (ISDN) and hydralazine (HYD) used in V-HeFT I and V-HeFT II, and BiDil, the proprietary fixed dose combination, used in the African American Heart Failure Trial (A-HeFT) demonstrated no bioequivalence. Non-bioequivalence in the formulations used may explain why V-HeFT I and V-HeFT II showed very different results in decreasing mortality. Using identical amounts of active drugs, the two formulations of ISDN and HYD were not bioequivalent to each other and neither were bioequivalent to BiDil, according to FDA requirements. The study results are being presented today in New Orleans at the American College of Cardiology's 56th Annual Scientific Session.

"This analysis is significant because it provides invaluable insight into the treatment of heart failure in black patients who suffer disproportionately compared to their white counterparts," said Milton Packer, M.D. a heart failure specialist and co-author of the study from the University of Texas, Southwestern Medical Center in Dallas. "Two large heart failure studies using two distinct formulations showed different results in decreasing mortality, only BiDil has shown significant reductions in death and hospitalization in black heart failure patients, as seen in A-HeFT. No drugs have been shown to be therapeutically equivalent to or substitutable for BiDil. Unproven remedies should not be used in a disease state where 50% of the patients will die within 5 years, and 50% of severe HF patients will die within one year," he said.

About BiDil

BiDil was approved in June 2005 by the U.S. Food and Drug Administration and is indicated for the treatment of heart failure as an adjunct to current standard therapy in self-identified black patients, to improve survival, prolong time to hospitalization for heart failure and improve patient-reported functio
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