The U.S. Food and Drug Administration has approved Bystolic (nebivolol) for the treatment of high blood pressure. Bystolic, a beta-blocker, belongs to a well-established class of medications that reduces blood pressure by reducing the force with which the heart pumps. It is a new drug not previously approved in the United States.
Nearly 1 in 3 adults in the United States has high blood pressure, also called hypertension, which can increase the risks for stroke, heart failure, heart attack, kidney failure, and death. "High blood pressure is often called the 'silent killer' because it usually has no symptoms until it causes damage to the body," says Douglas C. Throckmorton, FDA's deputy director of the Center for Drug Evaluation and Research. As he explains, "Bystolic offers a new treatment option for people who need to control their high blood pressure."
The safety and efficacy of Bystolic in lowering blood pressure was assessed in 3 randomized, double-blind, multicenter, placebo-controlled clinical trials that ran for as long as 3 months. A 4th placebo-controlled clinical trial demonstrated additional blood pressure-lowering effects when Bystolic was given with as many as 2 other antihypertensive medications to patients with inadequate blood pressure control.
Altogether, more than 2,000 people received Bystolic during the trials. Its efficacy during the trials was similar to that of other FDA-approved beta-blockers. The most common side effects reported by patients taking Bystolic in clinical trials were headache, fatigue, dizziness, and diarrhea.
Mylan Bertek Pharmaceuticals Inc. of Research Triangle Park, NC, USA is the sponsor of Bystolic. New York City-based Forest Laboratories, Inc. owns the rights for the sales and marketing of the drug. For more information, see What Is High Blood Pressure? by the National Heart Lung and Blood Institute at http://www.nhlbi.nih.gov/health/dci/Diseases/Hbp/HBP_WhatIs.html.
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