FDA Approves Heart Failure Drug for Blacks
Agency Says BiDil Is Meant for 'Self-Identified Black Patients'
June 24, 2005 -- The FDA has approved BiDil, a heart failure drug for blacks. The drug is "a step toward the promise of personalized medicine," says an FDA news release.
In heart attacks, high blood pressure, and infections.
the heart is weakened and doesn't pump enough blood. Heart failure's causes can include
Nearly 5 million people in the U.S. have heart failure. More than half a million new cases (550,000) are diagnosed each year, says the American Heart Association.
Heart Failure: More Common in Blacks
Heart failure can strike anyone. But it's
and people aged 65 and older, says the National Heart, Lung, and Blood Institute.
"Blacks are more likely to have heart failure and suffer more severely from it," says the NHLBI's web site. The NHLBI says blacks are more likely to:
- Develop heart failure symptoms at an earlier age
- Have their heart failure get worse faster
- Have more hospital visits for heart failure
- Die from heart failure.
Ask your doctor about any heart concerns. Health care workers can also help provide tips on improving your heart's health.
The approval is "a striking example of how a treatment can benefit some patients even if it does not help all patients," says Robert Temple, MD, in the FDA news release. Temple is the FDA's associate director of medical policy.
"The information presented to the FDA clearly showed that blacks suffering from heart failure will now have an additional safe and effective option for treating their condition," Temple says.
"In the future, we hope to discover characteristics that identify people of any race who might be helped by BiDil."
Heart Failure Drug's Trial
BiDil's approval was partly based on the results of the African-American Heart Failure Trial, says the FDA.
The study included 1,050 blacks with severe heart failure. They had already gotten the best available therapy for their condition.
The study was done because two previous trials suggested a benefit of BiDil in black patients, but not the general population of people with severe heart failure.
In the study, patients given BiDil had 43% fewer deaths and 39% fewer hospitalizations for heart failure, compared with those who got a placebo. Heart failure symptoms also dropped for the BiDil group, says the FDA.
Mix of 2 Older Drugs
BiDil combines two older drugs -- hydralazine and isosorbide dinitrate.
Hydralazine is a high blood pressure medicine. It relaxes the arteries and cuts the heart's work. Isosorbide dinitrate fights chest pain (angina) by relaxing veins and arteries.
Isosorbide's effect usually wears off after half a day. Hydralazine may prevent that from happening. But how the two drugs work together is not fully known.
Some common side effects with BiDil are headache and dizziness, says the FDA.
BiDil is marketed by NitroMed, Inc. of Lexington, Mass.