NitroMed says A-HeFT shows both black women and men benefit from BiDil heart therapy

By Lisa Kerner

Erie, Pa., March 14 - NitroMed, Inc. said results of a post-approval analysis of the African American Heart Failure Trial (A-HeFT) by gender demonstrated similar positive clinical outcomes for both black men and black women taking BiDil (isosorbide dinitrate/hydralazine hydrochloride) in addition to standard heart failure therapy.

A record 40% of participants in A-HeFT were black women, according to a company news release, making the gender comparison possible.

A separate post-approval analysis of A-HeFT results showed BiDil to be effective in black heart failure patients regardless of the severity of left ventricular remodeling, a measurement of decline in heart function, the company said.

Both sets of study results were presented at the American College of Cardiology's 55th Annual Scientific Session in Atlanta.

"These two analyses are significant as data from A-HeFT continue to provide invaluable insight into the treatment of heart failure in black patients," chief medical officer Dr. Michael L. Sabolinski said in the release.

"Through examination of this data, we have learned that BiDil has improved patient outcomes regardless of gender and that BiDil was effective for black patients with various degrees of left ventricular remodeling."

BiDil, approved in June 2005 by the Food and Drug Administration, is indicated for the treatment of heart failure as an adjunct to current standard therapy in self-identified black patients.

In A-HeFT, self-identified black patients taking BiDil in addition to current standard heart failure therapies experienced a 43% decrease in the risk of mortality, a 39% reduction in the risk of first hospitalization for heart failure and a statistically significant improvement in response to the Minnesota Living with Heart Failure Questionnaire.

NitroMed of Lexington, Mass., is a research-based emerging pharmaceutical company.

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