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Nebivolol Lowers Blood Pressure in Mild-to-Moderate Hypertensive Patients as Demonstrated in a Study Published in the Journal of Clinical Hypertension
Date:9/4/2007

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
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SOURCE Forest Laboratories, Inc.
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