The efficacy and tolerability of nebivolol in hypertensive African American patients

Abstract

Hypertensive African Americans often respond poorly to beta-blocker monotherapy, compared with whites. There is evidence, however, that suggests that this response may be different if beta-blockers with vasodilating effects are used. This 12-week, multi-center, double-blind, randomized placebo-controlled study assessed the antihypertensive efficacy and safety of nebivolol, a cardioselective, vasodilating beta1-blocker, at doses of 2.5, 5, 10, 20, or 40 mg once daily in 300 African American patients with stage I or II hypertension (mean sitting diastolic blood pressure [SiDBP] > or =95 mm Hg and < or =109 mm Hg). The primary efficacy end point was the baseline-adjusted change in trough mean SiDBP. After 12 weeks, nebivolol significantly reduced least squares mean SiDBP (P< or =.004) at all doses of 5 mg and higher and sitting systolic blood pressure (P< or =.044) at all doses 10 mg and higher, compared with placebo. The drug was safe and well-tolerated, with no significant difference in the incidence of adverse events compared with placebo. Nebivolol monotherapy provides antihypertensive efficacy, with few significant adverse effects, in hypertensive African Americans.

Figure 1

Trial profile. qd indicates once daily.

Figure 2

Placebo‐subtracted least squares mean reductions from baseline to study end in trough sitting diastolic blood pressure (SiDBP) (A) and trough sitting systolic blood pressure (SiSBP) (B). ^aP=not significant vs placebo. ^bP=.004 vs placebo. ^cP≤.001 vs placebo. ^d≤.045 vs placebo.

Figure 3

Response rates by treatment (patients with an average trough sitting diastolic blood pressure ≤90 mm Hg at study end or a decrease from baseline of ≥10 mm Hg). ^aP=not significant vs placebo. ^bP=.002 vs placebo.^cP<.001 vs placebo.