Evaluation of the efficacy and tolerability of nebivolol versus lisinopril in the treatment of essential arterial hypertension: a randomized, multicentre, double-blind study.

The main objective of this study was to compare the anti-hypertensive efficacy and safety of nebivolol (5 mg once daily) and lisinopril (20 mg once daily) given for 12 weeks in patients with mild to moderate essential hypertension. Fourteen centres participated in this randomized, double-blind parallel group study. Sixty-eight patients with uncomplicated mild-to-moderate hypertension were randomized, and sixty-five were eligible for the analysis of efficacy (intention-to-treat). Hypertensive patients were newly diagnosed, or previous antihypertensive therapy was withdrawn at least 1 month before active treatment, and were included in the study if their diastolic blood pressure (DBP) was > 95 and < 114 mmHg. The age range was 24-65 years. The primary endpoints of the study were: (i) response rate: patients were defined as "normalized" responders if their blood pressure values were < 140/90 mmHg, or as "non-normalized" responders if the reduction in blood pressure was 10 mmHg or more, compared with baseline; (ii) changes in sitting blood pressure at the end of the study. The secondary endpoints were: standing blood pressure and sitting or standing heart rate (HR). Results showed that baseline sitting DBP was significantly different between groups. Analysis of covariance of the raw data performed with baseline as covariate demonstrated that the DBP and HR values were significantly lower in the nebivolol group at the 8th week. However, when an analysis of variance for repeated measures was performed, a significant reduction in sitting systolic blood pressure (SBP) (p < 0.0001), DBP (p < 0.0001) and HR (p < 0.0001) was observed throughout the study in both groups. No difference was observed between treatments, although for DBP, a significant interaction between treatment-weeks was observed (p = 0.016). There was also a statistically significant difference in favour of the nebivolol group in the distribution of responders and non-responders at week 8. Lisinopril and nebivolol were equally well tolerated. In conclusion, nebivolol was slightly more effective, in comparison with lisinopril, in terms of reduction in DBP. This greater efficacy was obtained without any increase in adverse effects, since both treatments were equally well tolerated.

RCT Entities:   Population Interventions Outcomes