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KMID : 0648320080140030028
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Journal of The Korean Society of Hypertension
2008 Volume.14 No. 3 p.28 ~ p.36
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Double-blind, Randomized, Multi-center Trial for the Comparison of Efficacy and Safety between S-Amlodipine Besylate and Amlodipine Besylate in Patient with Hypertension
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Bae Jong-Hoa
Jun Jae-Eun
Lee Myoung-Mook
Kim Cheol-Ho
Hyon Min-Su
Choe Kyung-Hoon
Kim Dong-Soo
Hong Soon-Pyo
Lee Bang-Hun
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Abstract
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Background : Amlodipine besylate, a third generation dihydropyridine calcium channel blocker is a widely used
antihypertensive medicine. It is an isomer mixture of S-amlodipine and R-amlodipine. S-amlodipine besylate is known
as having a main role in lowering blood pressure (BP) in RS-amlodipine besylate. The aim of this study is to compare
S-amlodipine besylate with amlodipine besylate in their efficacy and safety.
Methods : Patients with essential hypertension were randomized into two groups of S-amlodipine besylate(2.5 mg) and amlodipine besylate(5 mg) for 8 weeks with dose adjustment. The changes in BP from baseline to 8 week were analyzed. Intention-to-treat (ITT) analysis and per-protocol (PP) analysis were used for efficacy evaluation with non-inferiority method. The adverse events (AEs) for the safety issue were also analyzed.
Results : Total number of patients enrolled was 118. Univariate analysis to identify the demographic characteristic and the medical background factors revealed no statistically significant differences between two groups. The upper bound of the two-sided 95% confidence interval (or one sided 97.5% interval) for the diastolic blood pressure difference between S-amlodipine besylate and amlodipine besylate were below non-inferiority margin (δ=5). No significant AEs were reported in both groups.
Conclusions : S-amlodipine besylate was not inferior in BP lowering effect when compared with amlidpine besylate. S-amlodipine besylate was also comparable with amlodpine besylate in safety issue.
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KEYWORD
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S-amlodipine besylate, amlodipine besylate, Hypertension
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