NitroMed, Inc. Study: Identical Doses of BiDil(R) Components Are Not Bioequivalent to the Fixed Dose Combination-BiDil-Used in A-HeFT

NEW ORLEANS, La.--(BUSINESS WIRE)--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.
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