Oxide-Enhancing Drug for Heart Failure Patients

A phase III clinical trial of an oxide-enhancing drug has been halted because of the significant survival benefit shown in patients with heart failure.

The trial involved 1,100 African-American men and women with moderate and severe heart failure. African Americans suffer a disproportionate incidence of cardiovascular disease. They are more likely to have heart failure and are more likely to die from it. The trial was the first to be conducted in an all African-American patient population.

The drug, called BiDil, is actually a combination of two medicines: isosorbide dinitrate and hydralazine. Hydralazine is an antioxidant and vasodilator agent that protects the nitric acid formed by isosorbide dinitrate from deactivating. BiDil is taken daily in addition to the best current therapy, such as beta blockers, diuretics, and digoxin. The African-American Heart Failure Trial (A-HeFT) showed that serious adverse cardiovascular events were less frequently observed in the BiDil arm of the trial. BiDil is the product of NitroMed (Lexington, MA, USA).

"Although the data need further analysis, NitroMed will work closely with the FDA to conclude the necessary A-HeFT data analysis and to ensure a complete and prompt filing of the data as an amendment to our previously submitted new drug application,” said Michael D. Loberg, Ph.D., president and CEO of NitroMed.




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