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) ⩾90 and ⩽109 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 −3.3, −3.5 and −4.6 mm Hg, respectively (P<0.001) and −5.7, −3.7 and −6.2 mm Hg in trough sitting systolic BP (SiSBP), respectively (P⩽0.015). Adding nebivolol 5–20 mg resulted in significantly more responders (SiDBP <90 or ⩾10 mm Hg reduction; range: 53.0–65.1 vs 41.3% with placebo; P⩽0.028) and significantly better control rates (SiSBP/SiDBP <140/90 mm Hg; range: 41.3–52.7 vs 29.3% with placebo; P⩽0.029). Nebivolol was well tolerated; the incidence of adverse events with nebivolol was similar to that with placebo (40.2 vs 38.9%, respectively; P=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.
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Acknowledgements
Bertek Pharmaceuticals Inc. (now part of Mylan Laboratories Inc.) provided all financial and material support for the research. Editorial assistance was provided by Strategic Medical Initiatives.
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Neutel, J., Smith, D. & Gradman, A. Adding nebivolol to ongoing antihypertensive therapy improves blood pressure and response rates in patients with uncontrolled stage I–II hypertension. J Hum Hypertens 24, 64–73 (2010). https://doi.org/10.1038/jhh.2009.33
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DOI: https://doi.org/10.1038/jhh.2009.33
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