A randomized, double-blind, placebo-controlled parallel-group study to assess the efficacy and safety of nebivolol, a novel beta-blocker, in patients with mild to moderate hypertension

Abstract

This double-blind, multicenter, randomized placebo-controlled study evaluated the antihypertensive efficacy and safety of nebivolol, a selective beta1-adrenoreceptor blocker with vasodilating effects, in patients with mild to moderate hypertension (sitting diastolic blood pressure [SiDBP] > or =95 mm Hg and < or =109 mm Hg). A total of 909 patients were randomized to receive placebo or nebivolol 1.25, 2.5, 5, 10, 20, or 40 mg once daily for up to 84 days. The primary end point was the change in trough SiDBP from baseline to study end. Nebivolol significantly reduced trough SiDBP (8.0-11.2 mm Hg compared with 2.9 mm Hg with placebo; P<.001) and trough sitting systolic blood pressure (a 4.4-9.5-mm Hg decrease compared with a 2.2-mm Hg increase [corrected] with placebo; P< or =.002). The overall adverse event experience was similar in the nebivolol (46.1%) and placebo (40.7%) groups (P=.273). Once-daily nebivolol is an effective antihypertensive in mild to moderate hypertensive patients.

Figure 1

Placebo‐subtracted least‐squares mean reductions in trough sitting diastolic blood pressure (SiDBP) (A) and trough sitting systolic blood pressure (SiSBP) (B) from baseline to study end. ^aP<.001 vs placebo. ^bP=.002 vs placebo.

Figure 2

Responder rates by treatment, defined as average trough sitting diastolic blood pressure ≤90 mm Hg at study end or a decrease of ≥10 mm Hg. ^aP=.008 vs placebo. ^bP=.001 vs placebo. ^cP<.001 vs placebo.