Placebo-controlled comparison of the effects of nebivolol and low-dose hydrochlorothiazide as monotherapies and in combination on blood pressure and lipid profile in hypertensive patients.

The effects of nebivolol, a new beta-blocker with vasodilating properties, and hydrochlorothiazide (HCTZ) as monotherapies and in combination on BP and plasma lipids, lipoproteins and apolipoproteins were compared with placebo in a parallel 3 x 4 factorial design study. After an eight week wash-out period, 240 patients with primary hypertension were randomised to receive either placebo, nebivolol 1, 5 or 10 mg, HCTZ 12.5 or 25 mg or one of the six possible combinations of nebivolol and HCTZ. Twenty patients were assigned to each of the 12 parallel groups. After 12 weeks of treatment, there was a significant dose-related reduction in BP among all active treatment groups. Apart from a slight and isolated increase in triglycerides with HCTZ 12.5 mg, lipid, lipoprotein and apolipoprotein levels as well as lipoprotein and apolipoprotein ratios were not significantly modified by 12 week active treatments when compared with placebo treatment. The results of this multifactorial study with 12 small sample size groups, suggest that nebivolol as monotherapy and in combination with HCTZ does not cause deleterious effects on the lipid profile.

RCT Entities:   Population Interventions Outcomes