NEBIVOLOL IN HYPERTENSION - A DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER STUDY ASSESSING ITS ANTIHYPERTENSIVE EFFICACY AND IMPACT ON QUALITY-OF-LIFE

Nebivolol is a selective beta1-adrenoceptor antagonist with a particul ar hemodynamic profile, suggesting an ancillary vasodilating property. The nature of this ancillary property is still unknown. The present d ouble-blind placebo-controlled multicenter study investigated the effe ct of 4 and 8 weeks treatment with nebivolot 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% red uction in diastolic BP (DBP). No evidence of drug tolerance was observ ed during the 8-week treatment period. Quality of life perception, as measured with the Inventory of Subjective Health (ISH) and the perceiv ed health rating scale, was not impaired with nebivolol during the ent ire 8-week study. Nebivolol showed a favorable adverse effect profile and appeared to be devoid of central nervous system (CNS) adverse effe cts. The total number of complaints with nebivolol treatment did not d iffer from the number of complaints with placebo treatment. ECG and bl ood analyses also show that nebivolol is safe and well tolerated. This study also shows that absolute drug-induced changes in quality of lif e perception can be assessed only in a placebo-controlled study and th at comparison with baseline might be incorrect and misleading.