FDA Okays New Beta Blocker

By Peggy Peck
ROCKVILLE, Md., Dec. 19 -- The FDA has approved a new drug in a very old class -- nebivolol (Bystolic) -- for treatment of hypertension.
A selective beta 1 blocker, nebivolol was tested in more than 2,000 patients in a series of clinical trials that included three randomized, double-blind, multicenter, placebo-controlled trials of the drug as monotherapy. In a fourth trial, when nebivolol was added to a two-drug regimen, patients achieved additional reductions in blood pressure.
Nebivolol is contraindicated in severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.
The drug should be used with caution in patients with peripheral vascular disease, thyrotoxicosis, severe renal impairment, and any degree of hepatic impairment or in patients undergoing major surgery. Caution should also be used in diabetic patients because beta blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia.
In general, patients with bronchospastic disease should not receive beta blockers.
Nebivolol should not be combined with other beta blockers.
Patients being treated with nebivolol should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported following the abrupt cessation of beta blockers.
When discontinuation is planned, the dosage should be reduced gradually over a one- to two-week period and the patient carefully monitored.
In clinical trials the most common adverse events with nebivolol were headache, fatigue, and dizziness.
Forest Laboratories owns the rights for the sale and marketing of the drug. The company said that nebivolol would be available in January 2008.