Nebivolol in hypertension: a double-blind placebo-controlled multicenter study assessing its antihypertensive efficacy and impact on quality of life.

Nebivolol is a selective beta 1-adrenoceptor antagonist with a particular hemodynamic profile, suggesting an ancillary vasodilating property. The nature of this ancillary property is still unknown. The present double-blind placebo-controlled multicenter study investigated the effect of 4 and 8 weeks treatment with nebivolol 5 mg once daily on blood pressure (BP), heart rate (HR), blood parameters, and ECG. The effect on quality of life perception and the adverse effect profile were also studied. Nebivolol 5 mg once daily had a good antihypertensive effect in supine (10/8 mm Hg) as well as in standing position (16/10 mm Hg). Of 114 patients studied, 65% had either normalization of or > 10% reduction in diastolic BP (DBP). No evidence of drug tolerance was observed during the 8-week treatment period. Quality of life perception, as measured with the Inventory of Subjective Health (ISH) and the perceived health rating scale, was not impaired with nebivolol during the entire 8-week study. Nebivolol showed a favorable adverse effect profile and appeared to be devoid of central nervous system (CNS) adverse effects. The total number of complaints with nebivolol treatment did not differ from the number of complaints with placebo treatment. ECG and blood analyses, also show that nebivolol is safe and well tolerated. This study also shows that absolute drug-induced changes in quality of life perception can be assessed only in a placebo-controlled study and that comparison with baseline might be incorrect and misleading.

RCT Entities:   Population Interventions Outcomes