One year of treatment with new agent achieved average pressure reduction of 14.8/15 mm Hg.
CHICAGO—A novel beta blocker under FDA review controls BP long term without the adverse effects associated with first-generation beta blockers, according to data presented here at the 22nd Annual Scientific Meeting of the American Society of Hypertension.
The new medication, nebivolol, is unique among beta blockers in that it is a vasodilator that enhances nitric oxide release. Therefore, it can improve endothelial function and has the potential to slow atherosclerosis, according to Vasilios Papademetriou, MD, professor of medicine at Georgetown University in Washington, D.C. Because nebivolol increases cardiac output, adverse effects such as fatigue and erectile dysfunction are less likely compared with traditional beta blockers such as atenolol, which are vasoconstrictors.
Beta blockers have fallen out of favor for the treatment of hypertension because of controlled clinical studies showing no improvement in outcomes with atenolol compared with placebo. Based on such trials, European guidelines no longer recommend beta blockers as first-line therapy for hypertension.
“Beta blockers have been discredited for one reason or another, but we need beta blockers for many of our patients because these agents slow heart rate, reduce oxygen demand, and decrease wall stress and shear forces,” Dr. Papademetriou said.
Dr. Papademetriou presented data from a nine-month extension study of 845 patients with mild-to-moderate hypertension who had previously completed one of three randomized, placebo-controlled, 12-week, dose-ranging studies with nebivolol monotherapy. Patients entering the extension study received 5, 10, or 20 mg of nebivolol once daily. If patients did not achieve an average sitting diastolic pressure of less than 90 mm Hg after 28 days, adjunct therapy with open-label diuretics or amlodipine was allowed.
In the 607 patients treated with nebivolol alone, the average BP reduction at the end of the extension phase (for a total of one year of treatment) was 14.8/15.0 mm Hg. This level of BP reduction “is as good as or better than that with other beta blockers or other agents for that matter,” Dr. Papademetriou said.
In the 206 patients in whom a diuretic was added, the average pressure reduction was 16.2/12.0 mm Hg. There were too few patients treated with amlodipine or other add-ons to allow for meaningful comparisons.
Overall, 74% of patients were considered responders to treatment, including 78.2% in the nebivolol monotherapy group, and 65.5% in the nebivolol plus diuretic group. Fatigue, dizziness, and depression were reported by 4.6%, 3.0%, and 0.9% of subjects. Thirty-one patients (3.7%) withdrew from the study because of adverse events: 26 in the nebivolol monotherapy group, four in the nebivolol plus diuretic group, and one in the group receiving nebivolol plus the calcium antagonist.
Researchers observed no clinically significant changes in serum glucose or lipids with nebivolol monotherapy throughout the study. Nebivolol was developed by Mylan Laboratories, which has licensed it to Forest Laboratories, based in New York City. In May, Forest said it anticipates the FDA will complete its review of the drug within six months.