Single center, Randomized, Single-blind, Parallel-group, Phase IV Clinical Trial for the Comparison of Efficacy and Safety between S-(-)-Amlodipine Nicotinate and Lercanidipine HCl in patients with hypertension

Youn, Jae Sung; Ahn, Yong Soo; Hwang, Young June; Jung, Hong Myong; Kim, Woo Jong; Lee, Min Geun; Kim, Su Hyun; Kim, Joon Young; Cho, Jang Hyun

Abstract

BACKGROUND
RS amlodipine, a third generation dihydropyridine calcium channel blocker is a widely used antihypertensive medicine. It is an mixture of S-amlodipine and R-amlodipine isomers. S-amlodipine is known to have a major role in lowering blood pressure (BP) during treatment with RS-amlodipine. Lercanidipine, a racemic mixture, is an effective calcium channel blocker used in the treatment of hypertension and known to have a lower incidence of peripheral edema. The aim of this study was to compare new S-(-)-amlodipine nicotinate with lercanidipine HCl in terms of their efficacy and safety.
METHODS
This study was an 8-week, single center, randomized, single-blind, parallel-group, phase IV, noninferiority clinical trial. After an initial 2-week screening period, we compared new S-(-)-amlodipine nicotinate with lercanidipine HCl with dose adjustment. Intention-to-treat (ITT) analysis and per-protocol (PP) analysis were used for efficacy evaluation. Adverse events were also analyzed.
RESULTS
A total of 61 patients were included in the ITT set (32 patients in the S-(-)-amlodipine nicotinate group, 29 patients in the lercanidipine HCl group). There were no statistically significant differences in demographic profiles or in their medical backgrounds. After 8 weeks of treatment, for the S-(-)-amoldipine group, sitting DBP and SBP were decreased, respectively, by -14.03+/-8.07 mmHg and -20.5+/-13.6 mmHg (p<.0001 compared to baseline). For the lercanidipine group, sitting DBP and SBP were decreased respectively, by -12.93+/-8.68 mmHg and -19.93+/-14.5 mmHg (p<.0001). There were no serious clinical or laboratory adverse effects in either of the two groups during treatment.
CONCLUSION
The efficacy and safety of S-(-)-amlodipine nicotinate is not significantly different from the efficacy and safety of lercanidipine HCl.