Nebivolol Lowers Blood Pressure in Mild-to-Moderate Hypertensive Patients as Demonstrated in a Study Published in the Journal of
September 04 2007 - 12:42PM
PR Newswire (US)
NEW YORK, Sept. 4 /PRNewswire-FirstCall/ -- Forest Laboratories,
Inc. (NYSE:FRX) announced the results of a controlled clinical
trial, published in the September 2007 issue of the Journal of
Clinical Hypertension, which demonstrated that nebivolol, a
selective beta 1-blocker with vasodilating properties,
significantly reduced sitting diastolic and systolic blood pressure
among patients with mild-to-moderate hypertension. The study - the
first to evaluate the drug in a U.S. population - also found that
nebivolol was well tolerated in comparison to placebo and was not
associated with adverse changes in blood glucose levels. Nebivolol
is currently under review by the U.S. Food and Drug Administration
(FDA) for the treatment of hypertension. "Next-generation beta
blockers, such as nebivolol, represent a step forward in the
treatment of hypertension," said Robert J. Weiss, M.D., Director
Cardiovascular Research, Maine Clinical Research. "As we saw in the
study, nebivolol demonstrated efficacy with a low incidence of side
effects typical of traditional beta blockers, such as fatigue,
erectile dysfunction, and depression. In addition, there were no
clinically significant changes in glucose levels, which makes
nebivolol useful in patients with certain metabolic disorders." In
the double-blind, placebo-controlled study, a total of 909 patients
were randomized to receive placebo (81 patients) or nebivolol (828
patients) dosed at 1.25mg, 2.5mg, 5mg, 10mg, 20mg or 40mg once
daily for up to 12 weeks. The 40mg dose was included to study
safety only. The study concluded that nebivolol, at doses of 1.25mg
to 20mg once daily, significantly reduced both trough sitting
diastolic and systolic blood pressure. Additionally, the study
demonstrated that nebivolol was well tolerated by comparison to
placebo treatment. Headache was the most common treatment-related
adverse event experienced by 7.1% of the pooled nebivolol-treated
patients (dosages of 1.25mg to 40mg once daily) and 7.4% of the
placebo-treated patients. Of note, in the pooled nebivolol group,
the incidence of AEs commonly associated with traditional beta
blocker use, including fatigue (3.6% vs. 2.5% with placebo),
erectile dysfunction (0.2%), and depression (0.2%) was low.
Moreover, nebivolol was not associated with adverse changes in
blood glucose values. "The publication of nebivolol's first U.S.
clinical trial further reinforces its longstanding use in patients
worldwide," said Neil Shusterman, M.D., Senior Vice President,
Clinical Development, Forest Research Institute. "The majority of
Americans afflicted with this disease are still not controlled, so
clearly there is a need for more treatment options. This study
showed that nebivolol significantly lowered blood pressure in
patients with mild-to-moderate hypertension and we anticipate it
will be an important therapy for physicians." About Hypertension
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. About Nebivolol 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. DATASOURCE: Forest Laboratories, Inc.
CONTACT: Charles E. Triano, Vice President - Investor Relations of
Forest Laboratories, Inc., +1-212-224-6714, or ; or Liesel Enke of
Fleishman-Hillard, +1-212-453-2427, or
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