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news.Forest Laboratories has announced positive results of a double-blind, randomized, placebo-controlled clinical trial, which demonstrated that nebivolol reduces sitting diastolic and systolic blood pressure. It was used as monotherapy among African-American patients with stage I-II hypertension.
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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 reduced sitting diastolic blood pressure at all daily doses.
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 FDA for the treatment of hypertension.
Elijah Saunders, lead investigator of the study and head, section of hypertension at the University of Maryland School of Medicine, said: “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. 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.”