Nebivolol monotherapy in younger adults (younger than 55 years) with hypertension: a randomized, placebo-controlled trial.

Nebivolol, a vasodilatory β1-blocker, may be well suited for the hemodynamics of the younger hypertensive patient. In this 8-week trial, 18- to 54-year-olds with a diastolic blood pressure (DBP) of 95 mm Hg to 109 mm Hg who completed a 4-week placebo-only phase were randomized to receive nebivolol (5 mg/d, titrated to 10-20 mg/d based on achievement of blood pressure <140/90 mm Hg [n=427]) or placebo (n=214). Primary and secondary efficacy parameters were changes in trough seated DBP and systolic blood pressure (SBP), respectively. Safety parameters included adverse events (AEs). The baseline mean age was 45.3 years; SBP/DBP, 154/100 mm Hg; and heart rate, 78 beats per minute. Completion rates were 91.3% (nebivolol) and 88.3% (placebo). At endpoint, there was a significant effect of nebivolol over placebo for DBP (-11.8 mm Hg vs -5.5 mm Hg, P<.001) and SBP (-13.7 mm Hg vs -5.5 mm Hg, P<.001). Total AE rates were 34.7% (nebivolol) and 32.2% (placebo). Nebivolol monotherapy is efficacious and well tolerated in adults younger than 55 years of age with increased DBP.