Personalized Therapy Receives Endorsement, Positive Post-Approval Results

PharmaManufacturing.com
03/15/2006

The Heart Failure Society of America (HFSA) recently issued its new Heart Failure Practice Guidelines, which address the incidence and treatment of heart failure in specific demographic populations, including African Americans. In the HFSA's recommendations for the management of heart failure in special populations, the guidelines recommend the use of a combination of isosorbide dinitrate and hydralazine as part of standard therapy, in addition to ACE inhibitors and beta-blockers, to treat African Americans with symptomatic heart failure. This combination is available as a proprietary fixed-dose formulation known as BiDil (isosorbide dinitrate/hydralazine hydrochloride), developed and exclusively marketed by NitroMed, Inc. (Lexington, Mass.), BiDil was approved by the U.S. Food and Drug Administration in June 2005 to treat heart failure in self-identified black patients, as adjunctive treatment to current standard therapies.

"BiDil has a major role to play in improving outcomes and symptoms for black heart failure patients, a group acutely and disproportionately affected by this chronic disease. The HFSA's recommendation that the combination of ISDN and hydralazine be considered standard therapy for African American patients with symptomatic heart failure is vitally important and, we believe, reflects the important contribution of BiDil to cardiovascular care," said Michael L. Sabolinski, M.D., Chief Medical Officer of NitroMed.

The new practice guidelines state that, "a combination of hydralazine and isosorbide dinitrate is recommended as part of standard therapy in addition to beta-blockers and ACE inhibitors for African Americans with left ventricular (LV) systolic dysfunction" and symptomatic heart failure.

These recommendations from the HFSA expand upon similar support from the American College of Cardiology (ACC) and the American Heart Association (AHA) in their joint heart failure guidelines issued last August. The HFSA guidelines further underscore the value of the proprietary combination of hydralazine and isosorbide dinitrate contained in BiDil, as demonstrated in the breakthrough African American Heart Failure Trial (A-HeFT), conducted by NitroMed in conjunction with the Association of Black Cardiologists, Inc. The HFSA guidelines provide a valuable reference for health care providers and are particularly important for the primary care physicians who treat and care for 80 percent of individuals diagnosed with heart failure.

In A-HeFT, self-identified black patients taking BiDil in addition to current standard heart failure therapies were compared to those taking a placebo in addition to current standard therapies. The BiDil group experienced a significant 43 percent decrease in the risk of mortality (P value of .012), a significant 39 percent reduction in the risk of first hospitalization for heart failure (P less than .001), and a significant improvement at most time points in response to the Minnesota Living with Heart Failure Questionnaire, which is a self-report of the patient's functional status. (For more information, click here to read an article from Genetic Engineering News.)

About the HFSA Guidelines

Originally released in 1999, the HFSA guidelines examine clinical trial results and expert views to highlight evidence-based approaches for the prevention, identification and treatment of heart failure. Although the guidelines are not mandatory, they enable physicians and health care professionals to make educated clinical assessments based on commonly accepted practices. These guidelines offer overarching recommendations to meet the needs of the vast majority of heart failure patients. HFSA's new guidelines are seen as a "living document" and will be continually updated as new information about the treatment of heart failure becomes available. The updated HFSA guidelines are available online at www.hfsa.org/journal.asp.

About the Heart Failure Society of America

The Heart Failure Society of America was founded in 1994 and is the first organized effort of heart failure experts from the Americas to provide a forum for all those interested in heart failure research and patient care. The Society also serves as a resource for governmental agencies (FDA, NIH, NHLBI, CMS), private industry, and health care providers. Additional information on HFSA can be found at www.hfsa.org.

About BiDil

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.

For more on BiDil, go to www.BiDil.com. For more information on NitroMed, Inc., visit www.nitromed.com.

Heart Failure Burden in Black Patients

Heart failure, or end-stage cardiovascular disease, affects approximately five million Americans, including an estimated 750,000 African Americans. This number is expected to grow to 900,000 by 2010. Heart failure is one of the few cardiovascular disorders on the rise, with over 550,000 people diagnosed each year. Unfortunately, there is no cure for heart failure and more than 50 percent of patients die within five years of diagnosis.

Heart failure is a progressive disease characterized by weakened heart muscles and as a result, a diminished ability of the heart to efficiently pump. As the disease progresses, the heart undergoes structural and functional impairment. Symptoms include shortness of breath, fatigue, swelling in the ankles or legs and difficulty sleeping.

The leading risk factor for heart failure in the African American community is hypertension. Blacks are affected by heart failure at a rate greater than that of the corresponding non-black population, presenting with the disease earlier and dying sooner. According to the Centers for Disease Control and Prevention (CDC), African Americans between the ages of 45 and 64 require hospitalization for heart failure more frequently and at a younger age, and are 2.5 times more likely to die from heart failure than Caucasians in the same age range.