BIDIL® FOR THE TREATMENT OF HEART FAILURE IN BLACK PATIENTS
 BiDil ® (isosorbide dinitrate 20 mg/hydralazine HCl 37.5 mg) is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status.*
Compared with patients on current standard therapies + placebo (n=532; ITT population), patients taking current standard therapies + BiDil (n=518; ITT population) in the African American Heart Failure Trial (A-HeFT) demonstrated:
- A statistically significant 43% reduction in all-cause mortality (P=.012) (absolute mortality rate: BiDil 6.2% vs. placebo 10.2%)*
- A statistically significant 39% reduction in risk of a first hospitalization for heart failure (P<.001) (absolute first hospitalization for heart failure rate: BiDil 16.4% vs. placebo 24.4%)*
- A statistically significant improvement in patient-reported functional status at most time points *
There is little experience in patients with NYHA Class IV heart failure. Most patients in the clinical trial supporting effectiveness (A-HeFT) received a loop diuretic, an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker, and a beta-blocker, and many also received a cardiac glycoside or an aldosterone antagonist.
The most common adverse events with BiDil in A-HeFT were:
Headache
- 50% of patients taking BiDil reported headaches compared with 21% of those taking placebo
- 7% of the active drug arm stopped study medication because of headaches
- Treatment of emerging headache was managed with acetaminophen in A-H
Dizziness
- 32% of patients taking BiDil reported dizziness compared with 14% of those taking placebo
- 4% of the active drug arm stopped study medication because of dizziness
Important Safety Information
Augmentation of the vasodilatory effects of isosorbide dinitrate by phosphodiesterase inhibitors (eg, Viagra ®/Revatio™, Levitra ®, Cialis ®) could result in severe hypotension.
Treatment with hydralazine may produce a clinical picture simulating systemic lupus erythematosus ( SLE) including glomerulonephritis. If SLE-like symptoms occur, discontinuation of BiDil should be considered.
Residua have been detected many years after discontinuation of hydralazine. Symptomatic hypotension may occur with even small doses of BiDil. BiDil should be used with caution in volume-depleted or hypotensive patients. Hydralazine can cause tachycardia potentially leading to myocardial ischemia and anginal attacks.
Caution should be exercised if BiDil ® (isosorbide dinitrate 20 mg/hydralazine HCl 37.5 mg) is used with MAO inhibitors, alcohol, Viagra ®/Revatio™ (sildenafil), Levitra ® (vardenafil), or Cialis ® (tadalafil).
* African-American Heart Failure Trial—a randomized, placebo-controlled, double-blind clinical trial with 1050 patients, self-identified as black (standard therapy + BiDil group, n=518; standard therapy + placebo group, n=532).
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