LEXINGTON, Mass., Feb. 23 /PRNewswire-FirstCall/ -- The Heart Failure Society of America (HFSA) has 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(R) (isosorbide dinitrate/hydralazine hydrochloride), developed and exclusively marketed by NitroMed, Inc. . 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.
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"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.
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 http://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 http://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.
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.
Important Safety Information
BiDil is contraindicated in patients who are allergic to organic nitrates. Augmentation of the vasodilatory effects of isosorbide dinitrate by phosphodiesterase inhibitors (e.g., Viagra(R)/Revatio(TM), Levitra(R), Cialis(R)) could result in severe hypotension.
Treatment with hydralazine may produce a clinical picture simulating systemic lupus erythematosus (SLE) including glomerulonephritis. If SLE-like symptoms occur, discontinuation of BiDil should be considered. Residua have been detected many years after discontinuation of hydralazine. Symptomatic hypotension may occur with even small doses of BiDil. BiDil should be used with caution in volume depleted or hypotensive patients. Hydralazine can cause tachycardia potentially leading to myocardial ischemia and anginal attacks. Careful clinical monitoring is recommended when BiDil is administered to patients with acute myocardial infarction to avoid hypotension and tachycardia. Isosorbide dinitrate therapy may aggravate angina associated with hypertrophic cardiomyopathy. Hydralazine has been associated with peripheral neuritis, evidenced by paresthesia, numbness and tingling, which may be related to an antipyridoxine effect. Caution should be exercised if BiDil is used with MAO inhibitors, alcohol, sildenafil, vardenafil or tadalafil.
Headache (50%) and dizziness (32%) were the two most frequent adverse events in A-HeFT and were more than twice as frequent in the BiDil group.
Viagra is a registered trademark and Revatio is a trademark of Pfizer, Inc.; Levitra is a registered trademark of Bayer HealthCare, GlaxoSmithKline, and Schering-Plough; Cialis is a registered trademark of Lilly ICOS LLC.
About NitroMed, Inc.
NitroMed of Lexington, Massachusetts is a research-based emerging pharmaceutical company and the maker of BiDil, an orally administered medicine available in the United States for the treatment of heart failure in self- identified black patients. In this population, BiDil is indicated as an adjunct to current standard therapies such as ACE inhibitors and/or beta blockers. BiDil was approved in June 2005 by the U.S. Food and Drug Administration, primarily on the basis of efficacy data from the Company's landmark A-HeFT (African American Heart Failure Trial) clinical trial, and since July 2005, has been marketed by NitroMed through a nationwide, dedicated contract sales force.
The Company is committed to the development of novel pharmaceuticals and safer, more effective versions of existing drugs to treat underserved patient populations. NitroMed's development efforts are primarily directed at expanding its cardiovascular franchise.
Forward Looking Statements
Statements in this press release about future expectations, plans and prospects for the Company, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: patient, physician and third-payer acceptance of BiDil as a safe and effective therapeutic; uncertainties relating to the impact, if any, of practice guidelines on market acceptance of BiDil; the effectiveness of the Company's marketing and sales strategy; the Company's ability to develop and maintain the necessary sales, marketing and manufacturing capabilities to launch and commercialize BiDil; adverse side effects experienced by patients; the Company's ability to obtain the substantial additional funding required to conduct manufacturing, marketing and sales of BiDil; unanticipated difficulties in maintaining regulatory approvals to market and sell BiDil; the Company's ability to obtain or maintain intellectual property protection and required licenses and other factors discussed in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2005, which has been filed with the SEC. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.
For full prescribing information, visit: http://www.BiDil.com.
BiDil is a registered trademark of NitroMed, Inc.
Video: http://www.prnewswire.com/mnr/nitromed/23679NitroMed, Inc.CONTACT: Sondra Newman, Investor Relations, +1-781-266-4197, cell:+1-781-640-3088; or Jane Kramer, Media, +1-781-266-4220, cell:+1-781-640-8499, both of NitroMed, Inc.
Web site: http://www.BiDil.com/
