CHICAGO, May 21 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. today presented positive data from two clinical studies and one pooled analysis of nebivolol, a selective beta 1-blocker with vasodilating properties currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension. Data from the two clinical studies show that nebivolol demonstrates blood pressure lowering effects as long-term therapy either alone or in combination with other agents, and also as part of a combination treatment for hypertension. The pooled analysis of three registration monotherapy trials supports nebivolol's blood pressure lowering effects for the treatment of hypertension in obese individuals, a difficult- to-treat patient population. The data were presented at the American Society of Hypertension, Inc. (ASH) 22nd Annual Scientific Meeting and Exposition (ASH 2007) in Chicago.
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Data presented at ASH includes:
-- "Long-Term Exposure to the Novel Beta-Blocker Nebivolol as Monotherapy
or Combination Therapy: Antihypertensive Efficacy and Safety" by
Vasilios Papademetriou, MD, Professor of Medicine, Georgetown
University. [Poster Presentation, P-419: Monday, May 21 from 12 pm to
1 pm (Riverside Hall)]
The long-term treatment effects of nebivolol were evaluated in a
multicenter, 9-month extension study (n=845) of patients who
successfully completed one of the three randomized, double-blind,
placebo-controlled registration studies. Patients received nebivolol
monotherapy (5 mg, 10 mg, or 20 mg once daily) or nebivolol plus
adjunct therapy (open-label diuretics or amlodipine). Outcomes
demonstrated that nebivolol treatment produced sustained blood pressure
reductions for the duration of the study period and was well tolerated
in all treatment groups. No clinically significant changes in glucose
or lipids were seen with nebivolol monotherapy during the study.
-- "Addition of the Beta-Blocker Nebivolol to Ongoing Therapy in the
Management of Mild-to-Moderate Hypertension" by Alan H. Gradman, MD,
Chief, Division of Cardiovascular Diseases, The Western Pennsylvania
Hospital. [Poster Presentation, P-383: Monday, May 21 from 12 pm
to 1 pm (Riverside Hall)]
The blood pressure lowering effects and tolerability of nebivolol added
to ongoing antihypertensive therapy in patients was evaluated in this
12-week, randomized, double-blind, placebo-controlled study (n=669).
Results indicate that, by comparison to placebo, nebivolol
incrementally lowers blood pressure in mild to moderate hypertensive
patients when added to ongoing antihypertensive therapy consisting of
one or two medications from the following classes: ACE inhibitors,
ARBs, or diuretics, with an incidence of reported adverse events
similar to placebo.
-- "Efficacy of the Novel Beta-blocker Nebivolol in Obese and Non-Obese
Hypertensive Patients" by James R. Sowers, MD, Professor of Medicine
and Physiology, Director Diabetes and Cardiovascular Center, University
of Missouri. [Poster Presentation, P-442: Monday, May 21 from 12 pm to
1 pm (Riverside Hall)]
The blood pressure lowering effects of nebivolol was compared in non-
obese and obese hypertensive patients, a population that typically has
a poorer response to treatment and an increased need for multiple
medications. The pooled analysis of three randomized, double-blind,
placebo-controlled trials of similar design was stratified by patient
obesity status (BMI greater than or equal to 30 kg/m2) at baseline
(obese, n=878; non-obese, n=1136). Results suggest that once-daily
nebivolol effectively lowers blood pressure to a similar extent in both
obese and non-obese hypertensive patients.
"These study results are promising and add to the growing body of data that support nebivolol as a useful treatment for hypertension across a broad population of patients," says Neil Shusterman, MD, Senior Vice President, Clinical Development, Forest Research Institute. "We feel that nebivolol will offer patients and physicians a unique option for managing high blood pressure."
Nebivolol is a selective beta 1-adrenergic (cardioselective) receptor antagonist 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, 2006 and on Form 10-Q for the periods ended June 30, 2006, September 30, 2006 and December 31, 2006.
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