Jacksonville, Fla. – NitroMed, Inc. halted the Phase III clinical trial of BiDil this week because of the significant survival benefit seen with the drug, announced Alan Miller, MD, UF cardiologist and professor of medicine, who led the trial at Shands Jacksonville. BiDil is the leading drug in development for the treatment of African Americans with heart failure.
The African American Heart Failure Trial, or A-HeFT, was designed to evaluate the efficacy of BiDil when taken daily in addition to the best current therapy. BiDil is an orally administered nitric oxide enhancing medicine that combines isosorbide dinitrate and hydralazine. “In the trial, we took a combination of medicines we thought did work with heart failure patients and repackaged them into a single drug that was tested in more than 1,000 African Americans in 170 sites in the United States, including here in Jacksonville,” said Miller.
All patients were on standard therapy. Half of them received the study drug while the other half received placebos. “I’m pleased that the end result is good. We’ve not only found a way to reduce the death rate in heart failure patients, but we can also help make them feel better,” Miller commented.
A-HeFT is the first and only heart failure trial conducted in an all African American patient population. There is no cure for heart failure and more than 50 percent of patients die within five years of diagnosis. African Americans suffer a disproportionate incidence of cardiovascular disease. Based on data from the Census Bureau and the Centers for Disease Control, it is estimated that 750,000 African Americans have been diagnosed with heart failure in the U.S. This number is expected to grow to approximately 900,000 by 2010.
NitroMed is currently working closely with the FDA to examine the data collected by the A-HeFT study. “We intend to have the necessary commercial resources in place to support a product launch by early 2005,” said Michael Loberg, PhD, president and CEO of NitroMed. For more information on BiDil or the clinical trial, go to www.nitromed.com.