15. Open Label, Randomized, Active Drug Comparative, Parallel Group, Multi-Center, Phase IV Study to Compare the Effect of Benidipine and Losartan on Arterial Stiffness and Central Blood Pressure in Mild to Moderate Essential Hypertensive Patients (Belasco Trial)

Abstract

Objectives

The purpose of this study was to compare the effect of benidipine (calcium channel blocker) and losartan (angiotensin receptor blocker) on arterial stiffness and central blood pressure (BP) in mild to moderate essential hypertensives.

Methods and Results

This 24 weeks, multi-center, open label, randomized, active drug comparative, parallel group study was designed as a noninferior study. Eligible patients (n = 200) were randomly assigned to receive benidipine (n = 101) or losartan (n = 99). Radial artery applanation tonometry and pulse wave analysis were used to derive central aortic pressure, pulse wave velocity (PWV) and augmentation index (AIx). No significant differences were found in the mean changes in central BP between 2 groups [−16.66 (systolic BP)/−10.70 (diastolic BP) mmHg in the benidipine group and −18.44/−11.79 mmHg in the losartan group; P = NS]. The mean changes in central, brachial and femoral PWV were −0.06, +0.06 and −0.51 m/sec for the benidipine group and −0.02, −0.15 and −0.06 m/s for losartan group (respectively; P = NS). No significant differences were found in the mean changes in AIx between two groups [−5.46 in the benidipine group and −4.22 in the losartan group; P = NS].

Conclusion

The reduction in central BP after 24 weeks of benidipine was non-inferior to that of losartan in mild to moderate essential hypertensives. There were no significant different between two drugs in aspect of PWV and AIx. Both drugs had similar central BP lowering effect and affected similarly arterial stiffness.