An Open Label, Multi-Center, Non-Interventional Study of the Safety of Nebivolol (Nebilet) In the Treatment of Hypertension in Filipino Adult Patients: A Post Marketing Surveillance Study

Abstract

Background: Nebivolol is a potent third generation beta-blocking agent indicated for the treatment of hypertension, and is distinguished from other beta blockers by its dual mechanism of action involving high β-1 cardioselectivity and unique nitric-oxide (NO) induced vasodilation. This study aims evaluate the safety and efficacy of Nebivolol (Nebilet) 5mg in the treatment of hypertension among Filipino adult patients. Methods: This is a prospective, open-label, non-interventional study which evaluated the safety of Nebivolol (Nebilet) 5mg in Filipino adult subjects with hypertension, aged 21 to 80 years, in an out-patient setting. Results: A total of 1,154 patients were recruited into the study, 36 (3%) of which had reported adverse events (AEs). Majority of the AEs were due to headaches (18%) and other non-specified events (32%). Most of the adverse events reported were mild to moderate and some were known effects of β- blockers. There were no serious or unsuspected adverse events described during the study. In terms of efficacy, nebivolol reduced blood pressure to less than 140/90 mmHg or a decrease of >10 mm Hg diastolic blood pressure (DBP) in 82% of subjects in the first follow-up visit. At the end of the treatment period, 97% had achieved target blood pressure levels. Conclusions: The study has shown that nebivolol is a safe and effective medication in hypertensive Filipino adult patients.