Data Presented at ASH Demonstrate Nebivolol Lowers Blood Pressure as Long-Term Monotherapy and in Combination Therapy
May 21 2007 - 9:00AM
PR Newswire (US)
Data Also Show Nebivolol Lowers Blood Pressure in Obese and
Non-Obese Hypertensive Patients CHICAGO, May 21
/PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE:FRX)
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. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) 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." About Nebivolol 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. http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Forest Laboratories, Inc.
CONTACT: Charles E. Triano, Vice President, Investor Relations, of
Forest Laboratories, Inc., +1-212-224-6714, ; or On-site Contact:
Paddi Hurley of Fleishman-Hillard, +1-917-743-2290, , for Forest
Laboratories, Inc. Web site: http://www.frx.com/
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