BiDil was shown to improve the lives of African Americans with HF in the A-HeFT study

African American Heart Failure Trial (A-HeFT) study overview

A-HeFT was the first study of patients with heart failure (HF) in which all of the participants identified themselves as African American. The study included 1,050 people split into 2 groups.1 One group added BiDil to their usual HF medicines. The other group took a placebo (sugar pill) along with their usual HF medicines. Nobody in either group knew if they were getting BiDil or the placebo. All of the patients in the study had HF that limited their physical activity or that prevented them from doing any physical activity at all without discomfort.1

Most patients in the trial received, in addition to BiDil or placebo, a loop diuretic, an angiotensin-converting enzyme inhibitor (ACE inhibitor) or an angiotensin receptor blocker (ARB), and a beta-blocker, and many also received a cardiac glycoside and/or an aldosterone antagonist.1

The study started in June 2001. By July 2004, the study showed that patients with HF who had been treated with BiDil were more likely to survive longer, have fewer hospitalizations for HF, and function better than patients taking standard HF therapy alone. Therefore, it was unanimously decided by an independent panel of experts to stop the study and make BiDil widely available.1

Such a young-at-heart outlook

Heart failure made him old before his time

BiDil helped HF patients live longer

When added to current standard HF medicines, BiDil reduced the risk of dying by 43% during the study.1

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

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 helped reduce the rate of first hospitalization

Risk of first hospitalization for HF was reduced by 39% in the A-HeFT study for those in the BiDil group compared with those on standard therapy alone.1

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

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 helped lead to an improvement in quality of life scores, as rated by the MLHFQ

Everyone in the study was asked to fill out the Minnesota Living With Heart Failure® questionnaire (MLHFQ). The MLHFQ helps doctors understand how certain physical symptoms associated with HF impact a person’s daily life. It covers topics such as2

  • Shortness of breath
  • Swelling of ankles or legs
  • Difficulty walking or climbing stairs
  • Feeling depressed or worried
  • How well a person sleeps at night
  • Feeling tired or low energy during the day

People in the BiDil group were more likely to say that they had improvement in their ability to function day to day, compared with those in the standard therapy plus placebo group.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


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


IMPORTANT SAFETY INFORMATION

Tell your doctor about any allergies you have, especially if you're sensitive to nitrates, such as nitroglycerin tablets or isosorbide dinitrate (Isordil®). BiDil has a nitrate component, so you need to let your doctor know.

Tell your doctor if you're taking any erectile dysfunction or pulmonary hypertension drugs like Viagra® or Revatio(sildenafil), Levitra® (vardenafil) or Cialis® (tadalafil).

Information for Patients about BiDil® (isosorbide dinitrate/hydralazine HCl)

BiDil is approved for use with other heart medicines to treat heart failure in black patients to improve survival, improve heart failure symptoms, and help patients stay out of the hospital longer. There is little experience in patients with heart failure who experience significant symptoms while at rest. Most patients in the clinical study of BiDil also received other heart failure medicines.

IMPORTANT SAFETY INFORMATION

Tell your doctor about any allergies you have, especially if you're sensitive to nitrates, such as nitroglycerin tablets or isosorbide dinitrate (Isordil®). BiDil has a nitrate component, so you need to let your doctor know.

Tell your doctor if you're taking any erectile dysfunction or pulmonary hypertension drugs like Viagra® or Revatio(sildenafil), Levitra® (vardenafil) or Cialis® (tadalafil).

WARNINGS AND PRECAUTIONS

Also tell your doctor if you are taking any medication to decrease blood pressure because when taken with BiDil, blood pressure may become too low.

It is possible you'll get headaches, especially at first, but they often lessen over time. Keep your doctor posted on your headache progress; he or she may want to adjust your dosage.

If you experience dizziness, call your doctor. Please make sure to tell your doctor about any of the signs or symptoms mentioned below or about any unusual events that worry you.

Drinking less fluids than your doctor recommends or losing fluid due to diarrhea, sweating, or vomiting may cause low blood pressure, lightheadedness, or fainting. If fainting occurs, stop taking BiDil and contact your doctor immediately.

Lightheadedness may occur when standing, especially after sitting or lying down.

If you experience any achy and/or swollen joints, unexplained fever for more than a few days, skin rashes, chest pain, prolonged weakness or fatigue (even after a good night's sleep), or any other unexplained signs or symptoms, make sure to tell your doctor as they may be signs of a serious medical condition.

You may also experience rapid heartbeat that could lead to chest pain or aggravate chest pain, or numbness or tingling in the hands or feet.

COMMON SIDE EFFECTS

Headache and dizziness were the most frequent side effects experienced in studies with BiDil.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here to see full Prescribing Information for BiDil. This information does not take the place of talking with your healthcare provider about your condition or your treatment. Ask your doctor if BiDil may be right for you.

References: 1. Taylor AL, Ziesche S, Yancy C, et al. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med. 2004;351(20):2049-2057. 2. Rector TS. Overview of the Minnesota Living with Heart Failure questionnaire. 2005:1-13.