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The African American Heart Failure Trial (A-HeFT) was terminated early following a recommendation from the independent Data Safety Monitoring Board due to a significantly lower mortality rate in the BiDil group.1, 4

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BiDil and the African American Heart Failure Trial (A-HeFT)
  1. What is BiDil?
  2. What was the clinical trial that studied BiDil?
  3. What were the "standard heart failure medicines"?
  4. What were the results?
  5. Why was it terminated early?
  6. How significant an advance is BiDil for the treatment of heart failure in African Americans?
  7. What are the clinical guideline recommendations for the treatment of heart failure in African Americans?
  8. Are there generic substitutes to BiDil?
  9. What about claims that BiDil is a 'Race Drug'?
General information about heart failure and how it's diagnosed
  1. What is heart failure?
  2. What causes heart failure?
  3. What are the most common conditions that lead to heart failure?
  4. How can the most common heart failure causes be prevented?
  5. What other conditions can lead to heart failure?
  6. What are the signs and symptoms of heart failure?
  7. How is heart failure diagnosed?
Risk of heart failure in African Americans
  1. Are African Americans really at greater risk for heart failure than other Americans?
  2. Why are African Americans at greater risk for heart failure?
Treatment for Heart Failure
  1. Can heart failure be cured?
  2. What are the steps for treating heart failure?
  3. How can I get the best results from the treatment plan my doctor recommends?
  4. How can I make the most of my doctor visits?
  5. What medications are commonly prescribed for heart failure?
  6. Are there new treatments for heart failure?
  7. Who shouldn't take BiDil?
  8. What are the most common side effects of BiDil?
  9. What should I do if I get a headache?
  10. What else do I need to know about the safety of BiDil?
  11. Will I be able to stop medication at some point?
  12. What if the cost of my medication is a concern?
  13. What if medication and other treatments don't keep my heart failure from progressing?
Other ways to manage Heart Failure
  1. Can I do anything else to keep myself healthy and prevent heart failure from worsening?
  2. How can I create an open line of communication with my doctor?
  3. How can I stay informed about my condition and treatment options?
  4. What heart-healthy changes should I consider making?
  5. How can I be successful at creating and keeping healthier habits?

1. What is BiDil?
BiDil is a fixed-dose combination medicine consisting of isosorbide dinitrate and hydralazine hydrochloride. It is approved by the FDA for the treatment of heart failure in self-identified African American patients when added to standard heart failure medicines.

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2. What was the clinical trial that studied BiDil?
The African-American Heart Failure Trial (known as A-HeFT) studied 1,050 self-identified African American patients with heart failure: It is the largest number of African American patients ever studied in a major heart failure trial. A-HeFT was a randomized, placebo-controlled, double blind trial with patients recruited at 169 centers in the United States.

The 1,050 patients were split into 2 groups - 532 patients in A-HeFT received a placebo pill (a sugar pill) on top of other standard heart failure medicines. The other 518 patients received BiDil on top of other standard heart failure medicines.

This clinical trial design is the optimal method for testing the effects of drug therapies. Patients were "randomized" which means they were randomly assigned to either the placebo group or the BiDil group. The trial was "placebo controlled" – meaning that one group took a placebo (a sugar pill) and one group took BiDil. "Double-blind" means that neither the patients nor the researchers know who got placebo and who got BiDil. This helps to prevent any unconscious or unintentional bias.

A-HeFT was started on May 29, 2001, and the study was halted early in July 2004 due to a significant survival benefit seen with BiDil as compared to standard therapy alone.

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3. What were the "standard heart failure medicines"?
All the patients in A-HeFT (in both groups) were well treated with existing standard heart failure medicines before receiving either BiDil or a placebo. The most used medicines were diuretics (received by 94% of patients), ACE-inhibitors or ARBs (received by 93% of patients) and beta-blockers (received by 87% of patients).

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4. What were the results?
A-HeFT showed that BiDil (when added to other standard heart failure medicines) delivered:

  • A 43% reduction in risk of death
  • A 39% reduction in the risk of 1st hospitalization for heart failure
  • A significant improvement in symptoms of heart failure

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5. Why was it terminated early?
In order to ensure patient safety all clinical trials have an independent group of doctors know as the "Data Safety and Monitoring Board" (DSMB). The DSMB is independent of the company and the doctors running the clinical trial.

The job of DSMB is to review the progress of the clinical trial at regular intervals. They check to ensure that the drug therapy is safe and is not doing any harm to patients. They also monitor the results to see if the study drug shows better than expected benefits or if it is not showing any difference from the placebo or other treatment used for comparison.

After a unanimous recommendation from the DSMB and Steering Committee in July 2004, A-HeFT was halted early due to a significant survival benefit seen with the drug as compared to standard therapy alone.

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6. How significant an advance is BiDil for the treatment of heart failure in African Americans?
The American Heart Association recognized BiDil as one of the top 10 advances in 2004.

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7. What are the clinical guideline recommendations for the treatment of heart failure in African Americans?
In 2009, the American College of Cardiology (ACC) and the American Heart Association (AHA) released their joint, updated guidelines for the Diagnosis and Management of Chronic Heart Failure in Adults. In March 2006, the Heart Failure Society of America (HFSA) issued updated heart failure treatment guidelines entitled, "HFSA 2006 Comprehensive Heart Failure Practice Guideline". In these important guidelines, A-HeFT was recognized.

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8. Are there generic substitutes to BiDil?
No. The FDA issued the following statement: "FDA has not approved any drug product under Section 505 of the Federal Food, Drug, and Cosmetic Act that is designated as therapeutically equivalent (i.e. substitutable) to BiDil. In addition, neither approved labeling for isosorbide dinitrate drug products nor approved labeling for hydralazine hydrochloride drug products contains information regarding the use of these drug products for the treatment of heart failure."

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9. What about claims that BiDil is a 'Race Drug'?
Only African American patients were studied in A-HeFT, so the FDA approval for BiDil is for "self-identified African American patients with heart failure" only. There is insufficient clinical trial data to draw any conclusions about the effects of BiDil in other populations.

It is anticipated that ongoing analysis of the genetic data from A-HeFT may help researchers identify specific genetic markers that may predict if a patient will benefit from the addition of BiDil. 354 patients from A-HeFT were enrolled in the Genetic Risk Assessment of Heart Failure (GRAHF) sub study. Although this research is at an early stage, preliminary results show that these genetic markers are not unique to any one racial group – although they may be more prevalent in one group versus another.

The FDA doctors who participated in the approval of BiDil wrote an article in the clinical journal Annals of Internal Medicine in January 2007 entitled, "BiDil for Heart Failure in African American Patients: The U.S. Food and Drug Administration Perspective". In this article they explain their decision to approve BiDil as follows:

"Not understanding the reasons for the difference in treatment effect by race did not justify withholding the treatment from those who could benefit from it.

Race or ethnicity is clearly a highly imperfect description of the genomic and other physiologic characteristics that cause people to differ, but it can be a useful proxy for those characteristics until the pathophysiologic bases for observed racial differences are better understood."

"The FDA approval of a fixed combination of hydralazine hydrochloride–isosorbide dinitrate to treat heart failure in self-identified African American patients was a scientifically reasonable, data-based decision, one that provided a major benefit in a group that is particularly burdened by congestive heart failure. The evidence of benefit in African American patients is very strong, and the evidence that white patients have less, if any, benefit, is also strong. We hope that further research elucidates the genetic or other factors that predict the usefulness of hydralazine hydrochloride–isosorbide dinitrate. Until then, we are pleased that one defined group has access to a dramatically life-prolonging therapy."

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10. What is heart failure?
Heart failure is a progressive condition in which your heart is not pumping blood as well as it should. Sometimes it is referred to as "congestive heart failure," when common symptoms of excess fluid buildup occur.

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11. What causes heart failure?
Heart failure is caused by one or more underlying conditions that have damaged or overworked the heart. As a result, the heart's ability to pump blood weakens over time.

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12. What are the most common conditions that lead to heart failure?
Coronary artery disease, in which the arteries become blocked with fatty plaque, is the most common cause of heart failure in America. High blood pressure and diabetes are other common causes, especially in African Americans.

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13. How can the most common heart failure causes be prevented?
Reducing your risk for heart failure begins with regular checkups to identify common but treatable causes, including high blood pressure, diabetes, and high cholesterol. Taking proper medicines consistently to control these conditions can lower your risk for heart failure. Heart-healthy habits — including a low-salt, low-fat diet, regular exercise, stress management, and no smoking or excessive alcohol use — can also help.

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14. What other conditions can lead to heart failure?
Other conditions that can lead to heart failure include malfunctioning heart valves, abnormal heartbeat (arrhythmia), heart defects you were born with, thyroid disorders, some cancer treatments, and more.

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15. What are the signs and symptoms of heart failure?
The most common signs and symptoms of heart failure are shortness of breath, fatigue that quickly develops with relatively little physical exertion, and swelling in the feet, legs, and abdomen.

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16. How is heart failure diagnosed?
Most cases of heart failure are not diagnosed until symptoms appear. Diagnosing heart failure requires a thorough physical examination and discussion with your doctor, as well as one or more tests of your heart function. An echocardiogram, which creates a moving image of your heart at work, is the most useful diagnostic test for heart failure. Other tests may include an electrocardiogram, X-rays and other imaging studies, an exercise stress test, and various blood tests.

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17. Are African Americans really at greater risk for heart failure than other Americans?
Yes. African Americans are 50% more likely to develop heart failure compared with other ethnic groups in the United States. In addition, African Americans tend to develop heart failure earlier in life and tend to have symptoms that are more severe and worsen more quickly, leading to more hospitalizations and deaths from this condition.

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18. Why are African Americans at greater risk for heart failure?
Two well-known contributors to the increased risk are much higher rates of high blood pressure and diabetes in the African American community. Other potential risk factors being explored are African Americans' lower access to and use of health care services, greater exposure to environmental pollutants, and greater tendencies to be overweight and to get less exercise.

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19. Can heart failure be cured?
Heart failure cannot be completely cured, although in some cases heart failure may be improved if the causes can be treated with surgery. In general, being diagnosed and starting treatment early with medicines can relieve symptoms and slow or prevent the progression of the disease. However, the medicines must be taken for the rest of your life.

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20. What are the steps for treating heart failure?
Typically, your doctor will suggest regular office visits to monitor your symptoms and will prescribe medicines to treat underlying causes and relieve the symptoms of your heart failure. Sometimes an underlying cause of heart failure — such as blocked arteries or malfunctioning heart valves — can be corrected with surgery or other procedures. Changes in health habits are also recommended, such as dietary improvements, more physical activity, and quitting smoking.

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21. How can I get the best results from the treatment plan my doctor recommends?
You should follow your doctor's advice as closely as possible, ask questions as needed, and share information about how you're dealing with the recommended treatment plan.

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22. How can I make the most of my doctor visits?
Bring a list of questions you need answered and take notes to record answers and any instructions your doctor gives. Provide information on other medications, vitamins, and other supplements you take. Also use these visits to share any frustrations about treatment with your doctor or inquire about help that's available for making lifestyle changes.

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23. What medications are commonly prescribed for heart failure?
Heart failure patients are usually treated with a combination of medications. ACE inhibitors are prescribed to lower blood pressure and expand blood vessels for easier blood flow. Beta-blockers, which also lower blood pressure as well as slow the beating of the heart, are also recommended. Diuretics can be used to reduce fluid buildup. Digoxin helps the heart beat stronger and pump more blood. Other medications may also be prescribed.

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24. Are there new treatments for heart failure?
Yes. Researchers are working on a number of new medications, devices, and other treatment options that may help heart failure patients. The U.S. Food and Drug Administration approved a pill called BiDil® (isosorbide dinitrate/hydralazine hydrochloride) for certain African American heart failure patients, along with other standard heart failure medicines. The large African American Heart Failure Trial (A-HeFT) showed that taking BiDil with other heart failure medicines helped African American heart failure patients live longer, reduce their risk for hospitalization, and function better.

Please see full Prescribing Information for BiDil.

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25. Who shouldn't take BiDil?
Anyone who is allergic to nitrates, such as nitroglycerin tablets or isosorbide dinitrate (Sorbitrate® or Isordil®) should not take BiDil. 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®/Revatio™ (sildenafil), Levitra® (vardenafil), or Cialis® (tadalafil). Mixing these with BiDil may cause a sudden drop in blood pressure, fainting, chest pain, or heart attack.

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.

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26. What are the most common side effects of BiDil?
Headaches often occur with treatment with BiDil, especially when starting treatment. These may become less frequent and less intense over time as you continue to take BiDil.

You may also feel lightheaded or dizzy, especially after getting up after lying or sitting. Consuming alcohol when taking BiDil could also cause you to feel lightheaded.

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27. What should I do if I get a headache?
Taking acetaminophen (such as Tylenol®) helped some patients relieve headaches. However, if headaches continue, tell your doctor. He or she may adjust your dose of BiDil.

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28. What else do I need to know about the safety of BiDil?
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 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
  • numbness or tingling in the hands or feet

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29. Will I be able to stop medication at some point?
No. Heart failure medicines are generally needed for life, even if you begin to feel better. Medication types and dosages may be changed, however. So regular doctor visits for tests and symptom monitoring are important.

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30. What if the cost of my medication is a concern?
Always talk to your doctor as soon as possible if cost is an issue. Many drug companies offer patient assistance programs that help people with limited income and no insurance coverage to afford their medicines. Your doctor can help you apply for these cost-savings programs. If your doctor prescribes BiDil for you, you may qualify for an assistance program offered by the manufacturer. The Arbor Patient Assistance Program offers free medicine to patients who are eligible.

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31. What if medication and other treatments don't keep my heart failure from progressing?
People with severe heart failure sometimes require hospitalization for special treatments and close monitoring. When medicine and lifestyle changes no longer keep symptoms manageable, heart failure patients may be considered candidates for an assistive device, such as a mechanical heart pump, or for a heart transplant.

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32. Can I do anything else to keep myself healthy and prevent heart failure from worsening?
Yes. Taking an active role in your care can help you get the best treatment possible. Ask questions during doctor visits and look for ways that help you stick with your treatment plan. In addition, taking steps toward heart-healthy changes in your daily life will go a long way toward helping you feel better and keeping you as healthy as possible in the long run.

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33. How can I create an open line of communication with my doctor?
Good doctors welcome patients who want to take an active role during their office visits. It helps them make the best treatment choices for the patient's particular case of heart failure. Bringing a list of questions that are important to you to each doctor visit will help get this kind of back-and-forth discussion rolling. You should also share any frustrations or problems you have with following your treatment plan. A reputable doctor will want to pay close attention and offer ways to help you.

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34. How can I stay informed about my condition and treatment options?
In addition to asking your doctor questions you need answers to, it never hurts to do some homework on your own. The Internet can be a wonderful resource for learning more about your condition, staying on top of new research, and reading about new treatment options. Choose Web sites with clear professional credentials, content that is updated regularly, and privacy policies that protect any information you provide. Never make changes based on Internet information, however, without asking your doctor first.

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35. What heart-healthy changes should I consider making?
Your doctor will likely recommend a diet low in salt and cholesterol, more physical activity to build strength and fitness, losing weight if needed, and quitting smoking and limiting consumption of alcohol.

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36. How can I be successful at creating and keeping healthier habits?
Don't expect to make drastic changes overnight without setting yourself up for frustration and failure. Take it one step at a time, but commit to reaching your goal. Always ask your doctor or nurse for resources that can help you make these changes easier. Most people need some outside guidance and support to develop new health habits that last.

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Information for Patients about BiDil®
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.

WARNINGS AND PRECAUTIONS
Tell your doctor if you're taking any erectile dysfunction or pulmonary hypertension drugs like Viagra® or Revatio™ (sildenafil), Levitra® (vardenafil) or Cialis® (tadalafil). Mixing these with BiDil may cause a sudden drop in blood pressure, fainting, chest pain, or heart attack.

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. For some patients, Tylenol® (acetaminophen) helps ease the discomfort. Keep your doctor posted on your headache progress and Tylenol use; 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.  Other side effects included chest pain, weakness, nausea, chest infection, low blood pressure, sinusitis, palpitations, high blood sugar, runny nose, tingling, vomiting, impaired vision, high cholesterol, and rapid heart rate. 

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.

Isordil is a registered trademark of Biovail Laboratories International SRL; Viagra is a registered trademark and Revatio is a trademark of Pfizer Inc.; Levitra is a registered trademark of Bayer Aktiengesellschaft and is used under license by GlaxoSmithKline; Cialis is a registered trademark of Eli Lilly and Company; Tylenol is a registered trademark of McNEIL-PPC, Inc.


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