Improving Survival in African American Patients with Heart Failure

Additional 43% reduction in mortality when added to current standard therapies (P=.012) - (absolute mortality rate: BiDil, 6.2% vs. placebo, 10.2%).¹

A-HeFT was terminated early following a recommendation from the independent Data Safety Monitoring Board, owing to a significantly higher mortality rate in the placebo group than in the group given BiDil.^1,4

Additional 39% risk reduction in first hospitalization for heart failure when added to current standard therapies (P<.001) (absolute first hospitalization for heart failure rate: BiDil, 16.4% vs. placebo, 24.4%).¹

Separation between the two study arms appeared as early as 100 days¹

Significant additional improvement in symptoms of heart failure when added to current standard therapies^1,4
Patients in the BiDil-treated group showed statistically significant improvement in self-reported functional status at most time points^1,4

• The MLHF Questionnaire^§ weighs the impact of physical symptoms associated with heart failure, functionality, and emotional attributes.¹¹ The following are sample components from the MLHF Questionnaire^‡:
  • shortness of breath
  • swelling in ankles or legs
  • walking or climbing stairs
  • feeling depressed or worried
  • having difficulty sleeping at night
  • being tired, fatigued, or low on energy

Patients in A-HeFT were maintained on standard background HF therapies^1,4

† Reduction represents full length of follow-up.

§ The Minnesota Living With Heart Failure® Questionnaire, a 21-question self-administered instrument with 0 to 5 scoring for each question; lower scores indicate improvement.¹¹

‡ The MLHF Questionnaire was not designed to measure any particular dimension separately; no conclusions can be drawn about drug effects on individual components.

* Angiotensin-converting enzyme
** Angiotensin II receptor blockers

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.