Isosorbide dinitrate/hydralazine is a drug combination specifically indicated for African Americans with congestive heart failure. It is a combination of hydralazine (an antihypertensive) and isosorbide dinitrate (a vasodilator). It is the first race-based prescription drug in the United States. The combination preparation is marketed in the United States by Nitromed under the trade name BiDil.

Originally rejected by the Food and Drug Administration (FDA) in 1997, the combination preparation was approved by the FDA in June 2005 for African American-use only based on the results of a study by Taylor et al. (2004). It was already known that African Americans with congestive heart failure (CHF) respond less effectively to conventional CHF treatments (particularly ACE inhibitors) than Caucausians. (Exner, 2001) The study by Taylor et al. demonstrated that isosorbide dinitrate with hydralazine reduced mortality by 43%, reduced hospitalizations by 33%, and quality of life markers in African Americans patients with CHF.

Some argue that because the combination preparation is comprised of two generically-available drugs, widely available at a small fraction of the cost, BiDil is a marketing breakthrough, rather than a medical one. Others argue that the combination reduces the "pill burden" for patients, which improves compliance and therefore the medical outcome.

References

• Exner DV, Dries DL, Domanski MJ, Cohn JN. Lesser response to angiotensin-converting-enzyme inhibitor therapy in black as compared with white patients with left ventricular dysfunction. N Engl J Med 2001;344(18):1351-7. PMID 11333991
• Taylor AL, Ziesche S, Yancy C, Carson P, D'Agostino R Jr, Ferdinand K, Taylor M, Adams K, Sabolinski M, Worcel M, Cohn JN. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med 2004;351:2049-57. PMID 15533851.

External links

• Official website
• FDA approval process page
• FDA approval press release

Pharmacologic agents