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Bidil Treatment for Heart Failure in African Americans

According to census bureau and the Centers for Disease Control (CDC), estimate 750,000 African Americans have been diagnosed with heart failure (Heart can no longer pump enough blood to the rest of the body.) and expect this number to grow to approximately 900,000 persons by 2010. Heart failure or end stage cardiovascular disease affects approximately five million Americans, and more than fifty percent of the patients die within the five years of diagnose, but more than half of these deaths occur in the African American population. In 2004, during the American Heart Association Scientific Sessions, reported blacks heart attack survivors often worse then white counterparts. Researchers, including Dr. Rajendra Mehta of Duke University Medical Center studied a one – year death rate for blacks after hospitalization for heart attack is 1.7 times higher than for whites. Also, blacks have a higher rate of strokes or major bleeding while getting clot – busting drugs in the hospital compared to their white counterparts. According to American Heart Association blacks tend to have the worst short and long term outcomes. Also, according to the study, African Americans heart attack patients were more likely to be younger, female, smokers and have high blood pressure, diabetes, and obesity. However, Dr. Mehta said: “Black patients tend to have arteries that respond better to treatment and were less likely to have sever hardening of the arteries.” Certain medications approved to use in heart failure are less effective in African American patients, documented in Food and Drug Administration product package inserts, such as Vasotec and Cozar. Also, certain medications have an adverse reaction linked to race, according to the FDA for example, people of Asian ancestry are more likely than others to have serious side effects from the cholesterol lowering drug Crestor. Other factors, contributing to higher mortality rate in African American heart attacks or failure, include poor diet, not receiving adequate health care or not having health insurance.

Naturally occurring compound in the human body is nitric oxide. Heart patients are known to suffer from a deficiency of nitric oxide (Also nitric oxide deficiency occurs in inflammatory diseases.), but the deficiency is more prevalent in African – Americans. Drug maker NitroMed (Lexington, Massachusetts) (NASDAQ: NTMD) manufactures a drug for heart failure therapy called BiDil: Makes it easier for the heart to pump by relaxing blood vessels and increases the body level of nitric oxide, effectively treats better heart failure in African Americans. During a clincial trial study of 1050 self – identified black patients with severe heart failure, and had no successful results from previous treatments, had experienced after being administered BiDil (Some patients were given a placebo) a forty-three percent reduction in death, a thirty-nine percent decrease in hospitalization for heart failure, and decrease of their symptoms of heart failure. The clinical study was concluded sooner, ensure those taking a placebo switch to BiDil to be treated. Dr. Robert Temple, FDA agency associate director of medical policy said: “The information presented to the FDA clearly showed that blacks suffering from heart failure will now have an additional safe and effective option for treating their condition.” Also, he said: “In the future, we hope to discover characteristics that identify people of any race who might be helped by BiDil.” A Nine member advisory panel unanimously recommended the FDA approve BiDil.

BiDil is a combination of two generic drugs orally – administered, isosorbide dintrate and hydralazine (neither previously approved for heart failure). issosorbide (anti – hypertensive agent) relaxes the veins and arteries, thus seems to release nitric oxide at the blood vessel wall. However, usually the effect wears of after a half a day. Hydralazine prevents this loss effect. BiDil recommended to be taken three times a day and besides any medications already prescribed to the patient. Further investigation is continuing, how these drugs (isosorbide and hydralazine) work together. Common adverse side effects include: Headaches (50% of patients) of which seventy percent during clinical trial have stopped taking the medication and received treatment, dizziness (32% of patients) of which four percent during clinical trail stopped taking the medication. The drug hydralazine may attribute to cause systemic lupus erthematosus (SLE – Chronic rheumatic disease which effects joints, muscles, and other parts of the body), discontinuation of BiDil should be considered. BiDil is not recommended when taking alcohol or Viagra.

In June 2005, Food and Drug Administration approved BiDil for heart failure drug, specifically for treating black patients (Previously in 1997, the drug failed to be approved because of studies supporting it were inconclusive). FDA issued a letter in May 2006, stating there is no bioequivalent, generic substitute to BiDil. Also the Food and Drug Administrated said the drug is a step towards the promise of tailored medicine. In 2007, patent for BiDil general use is due to expire but the FDA’s approval for use on black people wall extend until 2020. Physicians can prescribe the medication for use any way they see fit or if the drug works in other races. Wall Street Analysts predict BiDil sales (Factoring the use by people of other races) forecasts range $500 million to $1 billion by 2010. The drug has it’s own controversy. Jonathan Kahn, law professor and ethicist at Hamilton University in Minnesota who has studied BiDil’s development told Reuters: “This approval of BiDil isn’t about personalizing medicine. It’s about exploiting race to make money by extending patent protection.”