NEW YORK, Nov. 1 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) today announced the results of a double-blind, randomized, placebo-controlled clinical trial, published in the November 2007 issue of the Journal of Clinical Hypertension, which demonstrated that nebivolol significantly reduced sitting diastolic and systolic blood pressure used as monotherapy among African-American patients with stage I-II hypertension. The study also found that nebivolol was well tolerated in comparison to placebo, with a low incidence of traditional beta blocker side effects, such as fatigue, sexual dysfunction, and depression. In addition, nebivolol was not associated with adverse changes in blood lipids and glucose levels. Nebivolol, a novel beta blocker, is currently under review by the U.S. Food and Drug Administration for the treatment of hypertension.
African Americans have an increased prevalence of high blood pressure, develop elevated blood pressure earlier in life, and have higher rates of hypertension-related death from stroke, heart disease, and end-stage kidney disease. Although awareness of hypertension in African Americans has increased in recent years, their control rates (blood pressure <140/90 mm/Hg) remain low at approximately 30 percent.
"The findings of this study are important considering the excessive burden of high blood pressure in African Americans and the need for new treatment options," explains Elijah Saunders, MD, lead investigator of the study and professor of medicine and Head, Section of Hypertension at the University of Maryland School of Medicine. "Advances like this in the beta blocker class are particularly important because African Americans have an historically poor response to beta blocker therapy for hypertension."
In this 12-week double-blind trial, 300 African-American patients with stage I-II hypertension were randomly assigned to receive once-daily placebo or nebivolol at a 2.5, 5, 10, 20, or 40 mg dose. Among the 259 patients who completed the 12-week therapy, by comparison to placebo treatment, nebivolol significantly reduced sitting diastolic blood pressure at all daily doses . 5 mg and sitting systolic blood pressure at all daily doses . 10 mg with a low rate of side effects.
"This data further supports nebivolol's ability to lower blood pressure in a broad range of patients, including patients that are typically hard to treat with beta blockers such as African Americans," says Neil Shusterman, MD, Senior Vice President, Clinical Development of Forest Research Institute. "In addition to these blood pressure reductions, the low incidence of typical beta blocker side effects seen with nebivolol will make it a welcome addition to the existing treatment paradigm."
Hypertension, also known as high blood pressure, affects approximately 72 million people in the U.S. and 65 percent of patients diagnosed with hypertension have not reduced their blood pressure to an acceptable range. If left untreated, hypertension can eventually damage important organs such as the heart, brain, eyes or kidneys. High blood pressure greatly increases the risk of certain health problems such as stroke, heart attack, and kidney failure.
Nebivolol is a selective beta 1-blocker with vasodilating properties and is already approved and successfully marketed for the treatment of hypertension in more than 50 countries outside of North America.
About Forest Laboratories and Its Products
Forest Laboratories is a US-based pharmaceutical company dedicated to identifying, developing, and delivering products that make a positive difference in peoples' lives. Forest Laboratories' growing product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for the initial and maintenance treatment of major depressive disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl D- aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Benicar(R) * (olmesartan medoxomil), an angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan medoxomil- hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product, each indicated for the treatment of hypertension; and Campral(R) * (acamprosate calcium), indicated in combination with psychosocial support for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.
* Benicar is a registered trademark of Daiichi Sankyo, Inc., and Campral
is a registered trademark of Merck Sante s.a.s., subsidiary of Merck
KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in the Forest Laboratories' SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2007, and on Form 10-Q for the period ended June 30, 2007.
|SOURCE Forest Laboratories, Inc.|
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