Efficacy and tolerability of nebivolol in stage I-II hypertension: a pooled analysis of data from three randomized, placebo-controlled monotherapy trials.

Background: Nebivolol is a β(1)-selective β-blocker with NO-mediated vasodilatory properties, approved in the United States for the treatment of stage I-II hypertension.

Objective: The purpose of this pooled analysis was to summarize efficacy and provide a brief overview of the tolerability associated with the use of nebivolol.

Methods: PubMed was searched for randomized, double-blind, placebo-controlled, parallel-group trials of monotherapy with nebivolol for stage I-II hypertension of at least 12 weeks' duration. This article reports pooled changes in sitting diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR) at trough; proportions of responders (patients whose end-point sitting DBP at trough was <90 mm Hg or whose sitting DBP at trough had decreased from baseline by ≤10 mm Hg); and the most frequent adverse events (AEs). These data were also summarized in the subpopulation of black patients.

Results: The literature search yielded 3 similarly designed studies. In all 3 trials, a single-blind placebo run-in phase (4-6 weeks) was followed by randomization (baseline) and a 12-week double-blind treatment phase in which patients received nebivolol 1.25 to 30 or 40 mg/d or placebo. The primary efficacy measure in all 3 trials was the mean change from baseline in sitting DBP at 12 weeks, based on the intent-to-treat population. In the pooled sample, 930 (46.1%) patients were women, and the mean age was 53.6 years. Compared with placebo (n = 205), the reductions in DBP (up to 11.1 mm Hg), SBP (up to 12.4 mm Hg), and HR (up to 9.2 beats/min) were significantly greater with nebivolol (n = 1811) at the recommended dosages of 5-30/40 mg/d (all, P < 0.001). The most commonly reported AEs were headache (nebivolol, all dosages, 7.1%; placebo, 5.9%), fatigue (3.6% vs 1.5%, respectively), and nasopharyngitis (3.1% vs 4.4%). The efficacy and tolerability of nebivolol in black patients were similar to those observed in the total study population.

Conclusion: Based on the pooled results from the 3 monotherapy trials reported here, nebivolol administered for 12 weeks was efficacious and generally well tolerated in patients with stage I-II hypertension.