The most common adverse events with BiDil in A-HeFT were:1
Headache
- 50% of patients taking BiDil reported headaches compared with 21% taking placebo
- 7% of the active drug arm stopped study medication because of headaches
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Patients should be told that headaches often accompany treatment with BiDil, especially during initiation of treatment
- Headaches tend to subside even with continued dosing
- Treatment of emerging headaches can be managed with acetaminophen
Dizziness
- 32% of patients taking BiDil reported dizziness compared with 14% taking placebo
- 4% of the active drug arm stopped study medication because of dizziness
In A-HeFT, 21% of patients discontinued BiDil for adverse experiences compared to 12% who discontinued placebo.
Important information about BiDil®
(isosorbide dinitrate/hydralazine hydrochloride):
INDICATIONS AND USAGE
BiDil 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. 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.
CONTRAINDICATIONS
BiDil is contraindicated in patients who are allergic to organic nitrates.
WARNINGS
Augmentation of the vasodilatory effects of isosorbide dinitrate by phosphodiesterase inhibitors such as sildenafil, vardenafil, or tadalafil could result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Reasonable supportive care should consist of those measures used to treat a nitrate overdose with elevation of the extremities and central volume expansion.
ADVERSE REACTIONS
Adverse events reported in A-HeFT and seen more frequently in the group given BiDil included headache (50% in BiDil patients vs. 21% in placebo patients) and dizziness (32% in BiDil patients vs. 14% in placebo patients).
The full Prescribing Information for BiDil is available here.
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