Adding nebivolol to ongoing antihypertensive therapy improves blood pressure and response rates in patients with uncontrolled stage I–II hypertension

Abstract

This study assessed blood pressure (BP) reductions and response rates following addition of nebivolol to ongoing antihypertensive therapy in patients with uncontrolled stage I-II hypertension despite antihypertensive treatment. Patients with an average sitting diastolic BP (SiDBP) X90 and p109 mm Hg while taking an antihypertensive regimen were included in this double-blind, placebo-controlled, parallel-group study. The primary efficacy end point was reduction from baseline to week 12 in mean trough SiDBP. In total, 669 patients were randomized to once-daily nebivolol 5, 10 or 20 mg or placebo. Addition of nebivolol 5, 10 and 20 mg significantly reduced BP; placebo-subtracted least squares mean reductions in trough SiDBP were À3.3, À3.5 and À4.6 mm Hg, respectively (Po0.001) and À5.7, À3.7 and À6.2 mm Hg in trough sitting systolic BP (SiSBP), respectively (Pp0.015). Adding nebivolol 5-20 mg resulted in significantly more responders (SiDBP o90 or X10 mm Hg reduction; range: 53.0-65.1 vs 41.3% with placebo; Pp0.028) and significantly better control rates (SiSBP/ SiDBP o140/90 mm Hg; range: 41.3-52.7 vs 29.3% with placebo; Pp0.029). Nebivolol was well tolerated; the incidence of adverse events with nebivolol was similar to that with placebo (40.2 vs 38.9%, respectively; P ¼ 0.763). Addition of once-daily nebivolol to ongoing antihypertensive therapy provided significant additional BP reductions and better response rates in patients with uncontrolled hypertension and was well tolerated.

Efficacy and safety of nebivolol in Hispanics with stage I-II hypertension: a randomized placebo-controlled trial

“…The results of this study support findings from other nebivolol trials in hypertension [Greathouse, 2010;Neutel et al 2009;Saunders et al 2007;Weiss et al 2007;Van Nueten et al 1998, 1997: nebivolol is efficacious in reducing BP in participants with stage III hypertension, associated with an AE rate similar to that of placebo, and a low rate of AEs commonly associated with beta-blocker use (dyspnea, 0%; fatigue, 0%; sexual dysfunction, 0.7%) [Munzel and Gori, 2009]. The relatively low incidence of AEs in this study and other nebivolol clinical trials [Ambrosioni and Borghi, 2005] may be attributable to its high ß1-selectivity and NO-mediated vasodilatory effects [Munzel and Gori, 2009].…”

Effects of Add‐On Nebivolol on Blood Pressure and Glucose Parameters in Hypertensive Patients With Prediabetes

“…Treatment with nebivolol as add-on or combination therapy has been shown to provide a significant BP reduction in several randomized trials, [29][30][31][32] including those in which ACE inhibitors or ARBs were used as background therapy 31 or in initial combination. 33 In addition, a neutral or favorable metabolic profile of nebivolol has been demonstrated in several studies of patients with dysglycemia.…”

Nebivolol

“…[37][38][39][40] Two of the trials evaluated nebivolol monotherapy in the general population, [37,38] one evaluated nebivolol monotherapy in Black patients, [39] and another evaluated nebivolol as add-on therapy to an existing antihypertensive regimen. [37][38][39][40] Two of the trials evaluated nebivolol monotherapy in the general population, [37,38] one evaluated nebivolol monotherapy in Black patients, [39] and another evaluated nebivolol as add-on therapy to an existing antihypertensive regimen.…”

“…[37][38][39][40] Two of the trials evaluated nebivolol monotherapy in the general population, [37,38] one evaluated nebivolol monotherapy in Black patients, [39] and another evaluated nebivolol as add-on therapy to an existing antihypertensive regimen. [37][38][39] Participants in the double-blind, 12-week trials (n = 909, [38] 807, [37] 300, [39] and 669 [40] ) had mild to moderate hypertension (defined as mean sitting DBP between 90 [40] or 95 [37][38][39] and 109 mmHg) and were randomized to receive 12 weeks' treatment with placebo or nebivolol 1.25-40 mg (patients randomized to the 40 mg group received nebivolol 30 mg once daily for 2 weeks before titration to 40 mg if eligible), [38] 2.5-40 mg, [39] or 5-20 mg [37,40] once daily. [37][38][39] Participants in the double-blind, 12-week trials (n = 909, [38] 807, [37] 300, [39] and 669 [40] ) had mild to moderate hypertension (defined as mean sitting DBP between 90 [40] or 95 [37][38][39] and 109 mmHg) and were randomized to receive 12 weeks' treatment with placebo or nebivolol 1.25-40 mg (patients randomized to the 40 mg group received nebivolol 30 mg once daily for 2 weeks before titration to 40 mg if eligible), [38] 2.5-40 mg, [39] or 5-20 mg [37,40] once daily.…”

“…In the study of patients who met the criteria for mild to moderate hypertension despite receiving stable dosages of one or two classes of antihypertensive therapy, [40] nebivolol was added to patients' existing standard antihypertensive treatments (apart from b-adrenergic receptor antagonists, which were discontinued with a 14-day washout period). Patients were receiving established therapy of one (72.6%) or two medications (26.3%).…”