BiDil has shown specific benefits for African Americans with HF

Only BiDil has delivered the outcome improvements shown in the African American Heart Failure Trial (A-HeFT). BiDil has demonstrated significant results in improving survival, reducing the rate of first hospitalization for heart failure (HF), and improving quality of life in self-identified African American patients when added to current standard therapies.1

BiDil was proven to make a difference in the lives of African American patients in the A-HeFT study.1

BiDil improved survival by an additional 43% in A-HeFT1,2

BiDil gave African American patients with heart failure a 43% reduction in mortality when added to current standard therapies.1,2

Because of the significantly lower mortality rate in the BiDil group vs the placebo group, (6.2% vs 10.2%, respectively; P=0.012), the independent data and safety monitoring board recommended unanimously to terminate the trial early.1

Kaplan-Meier Plot of Time to Death by Any Cause in Black Patients (A-HeFT)1,2

Study design: Randomized, placebo-controlled, double-blind, multicenter trial of 1,050 self-identified African American patients aged 18 years or older with New York Heart Association class III or IV heart failure. Patients were required to be on standard HF therapy (angiotensin-converting enzyme [ACE] inhibitors, beta blockers, and diuretics) and have evidence of left ventricular dysfunction within 6 months preceding randomization. The primary efficacy endpoint was a composite score made up of weighted values for death from any cause, first hospitalization for HF during the 18-month follow-up period, and QoL change at 6 months.1

BiDil reduced the risk of first hospitalization for heart failure by 39% in A-HeFT

BiDil provided patients with a 39% reduced rate of first hospitalization for heart failure when added to current standard therapies.2

A-HeFT evaluated the time to first hospitalization for heart failure as a component of the primary composite score in patients treated with BiDil plus standard therapy (n=518) vs patients who were given a placebo (n=532). At an average follow-up time of 10 months, only 16% of patients (n=85) who were treated with BiDil plus standard therapy were hospitalized, compared with 24% of patients (n=130) who were given a placebo; P=0.001. The relative risk reduction was 39% (HR=0.61, 95% CI, 0.46–0.80; P<0.001). The treatment effect appeared as early as 50 days and remained significant throughout the length of the study.3

Kaplan-Meier Plot of Time to First Hospitalization for Heart Failure in Black Patients (A-HeFT)2

Reduction represents full length of follow-up.

Study design: Randomized, placebo-controlled, double-blind, multicenter trial of 1,050 self-identified African American patients aged 18 years or older with New York Heart Association class III or IV heart failure. Patients were required to be on standard HF therapy (angiotensin-converting enzyme [ACE] inhibitors, beta blockers, and diuretics) and have evidence of left ventricular dysfunction within 6 months preceding randomization. The primary efficacy endpoint was a composite score made up of weighted values for death from any cause, first hospitalization for HF during the 18-month follow-up period, and QoL change at 6 months.1

BiDil improved QoL for African Americans with HF in the A-HeFT study

BiDil helped patients achieve an improved quality of life (QoL), as rated by the Minnesota Living with Heart Failure® questionnaire (MLHFQ).1 Changes in QoL scores from baseline at 3 and 6 months were significant and independently associated with a composite of mortality or first HF hospitalization in A-HeFT.4

When added to standard therapies, BiDil was reported to show statistically significant improvement in self-reported status at most time points.1 Sample components included in the MLHFQ are5

  • Shortness of breath
  • Swelling in ankles or legs
  • Difficulty walking or climbing stairs
  • Feeling depressed or anxious
  • Difficulty sleeping at night
  • Feeling tired, fatigued, or low on energy

BiDil improved QoL, as rated by the MLHFQ2

The MLHFQ is a 21-question, self-administered instrument with 0 to 5 scoring for each question. Lower scores indicate improvement. The MLHFQ was not designed to measure any particular dimension separately; no conclusions can be drawn about drug effects on individual components.1

Study design: Randomized, placebo-controlled, double-blind, multicenter trial of 1,050 self-identified African American patients aged 18 years or older with New York Heart Association class III or IV heart failure. Patients were required to be on standard HF therapy (angiotensin-converting enzyme [ACE] inhibitors, beta blockers, and diuretics) and have evidence of left ventricular dysfunction within 6 months preceding randomization. The primary efficacy endpoint was a composite score made up of weighted values for death from any cause, first hospitalization for HF during the 18-month follow-up period, and QoL change at 6 months.1

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IMPORTANT SAFETY INFORMATION

BiDil is contraindicated in patients who are allergic to organic nitrates, or who take a phosphodiesterase type 5 (PDE5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulator (riociguat). Concomitant use can cause hypotension.

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.

IMPORTANT SAFETY INFORMATION

BiDil is contraindicated in patients who are allergic to organic nitrates, or who take phosphodiesterase type 5 (PDE5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulator (riociguat). Concomitant use can cause hypotension.

WARNINGS AND PRECAUTIONS

Hydralazine hydrochloride has been reported to cause a drug-induced systemic lupus erythematosus (SLE) syndrome. Symptoms and signs usually regress when hydralazine hydrochloride is discontinued.

Symptomatic hypotension, particularly with upright posture, may occur with even small doses of BiDil. Hypotension is most likely to occur in patients who have been volume or salt depleted; correct prior to initiation of BiDil. Hydralazine hydrochloride can cause tachycardia and hypotension potentially leading to myocardial ischemia and angina, particularly in patients with hypertrophic cardiomyopathy.

Hydralazine hydrochloride has been associated with peripheral neuritis, evidenced by paresthesia, numbness, and tingling, which may be related to an antipyridoxine effect. Pyridoxine should be added to BiDil therapy if such symptoms develop.

ADVERSE REACTIONS

Most common adverse reactions (> 5% more on BiDil than on placebo) were headache and dizziness.

The full Prescribing Information for BiDil is available here.

References: 1. Taylor AL, Ziesche S, Yancy CW, et al. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med. 2004;351(20):2049-2057. 2. BiDil [package insert]. Atlanta, GA: Arbor Pharmaceuticals, Inc; 2015. 3. Ferdinand KC. The isosorbide-hydralazine story: is there a case for race-based cardiovascular medicine? J Clin Hypertens. 2006;8(3):156-158. 4. Carson P, Tam SW, Ghali JK, et al. Relationship of quality of life scores with baseline characteristics and outcomes in the African-American Heart Failure Trial. J Card Fail. 2009;15(10):835-842. 5. Rector TS. Overview of the Minnesota Living with Heart Failure® Questionnaire. January 1, 2005. http://license.umn.edu/technologies/94019_minnesota-living-with-heart-failure-questionnaire. Accessed August 13, 2015.