“Compelling” benefits have led Nitro-Med to stop a phase III trial of its heart drug BiDil® a year ahead of schedule so that placebo patients in the study could take it as well. BiDil® is a combination of isosorbide dinitrate (e.g., Isordil, Wyeth), a nitric oxide donor, and hydralazine (Apresoline®, Novartis), an antioxidant and vasodilator.
The African-American Heart Failure Trial (A-HeFT) involved more than 1,000 patients in 170 sites in the U.S. Although the data are preliminary, the trial found a statistically significant survival benefit along with fewer serious adverse drug events in patients taking BiDil than in those taking a placebo.
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The findings are consistent with those from V-HeFT I, an earlier trial in which patients took BiDil® along with digoxin and diuretics. In A-HeFT, patients were given BiDil® in addition to a “full spectrum of modern therapies,” including beta blockers, angiotensin antagonists, and aldosterone inhibitors.
A-HeFT is the largest database of African-Americans with heart failure, according to the Association of Black Cardiologists, which co-sponsored the trial. The incidence of heart failure is disproportionately high among African-Americans, and they are more likely than white patients to die as a result.