Randomized study of benidipine versus lercanidipine therapy in patients with mild to moderate hypertension
Journal
Journal of Internal Medicine of Taiwan
Journal Volume
31
Journal Issue
5
Date Issued
2020-10-01
Author(s)
Wang, Kang Ling
Yu, Wen Chung
Shyu, Kou Gi
Hung,Cheng Yu
Tzeng, Bing Hsiean
Cheng, Shu Meng
Abstract
The calcium channel blocker (CCB) benidipine is used as a first-line antihypertensive agent in hypertension. This multicenter, randomized, double-blind, double-dummy, lercanidipine-controlled trial aimed to evaluate the efficacy and safety of benidipine 4 mg in 178 patients with essential hypertension in Taiwan. After a 4-week treatment, mean change in systolic blood pressure (SBP) was -14.07 mmHg [95% confidence interval [CI]: -17.07 to -11.08] and -11.55 mmHg [95% CI: -14.24 to -8.86] in the benidipine and lercanidipine arms, respectively. Since the upper limit of the 95% CI (1.59) of the adjusted group difference in mean change of SBP at week 4 was less than 4.5 mmHg, benidipine could be considered non-inferior to lercanidipine based on the per protocol population. The diastolic BP was reduced by -5.81 mmHg (95% CI: -7.67 to -3.94) and -5.56 mmHg (95% CI: -7.14 to -3.99) in the benidipine and lercanidipine arms, respectively, after a 4-week treatment; no significant difference was noted (p = 0.9856). The BP target (< 140/90 mmHg) achievement showed no significant difference (p = 0.4087) or intervention advantage (odds ratio [OR] = 1.38,95% CI: 0.64-2.95) in proportion of responders between groups. In total, 13 and 14 subjects in the benidipine and lercanidipine groups, respectively, experienced study drug-related adverse events (AEs), consistent with expected side effects. No serious AEs or deaths occurred during the study. In conclusion, benidipine 4 mg could be considered non-inferior to lercanidipine 10 mg after 4 weeks of antihypertensive treatment with an acceptable tolerability profile.
Subjects
Benidipine | Hypertension | Lercanidipine
Type
journal article