경도 또는 중등도의 본태성 고혈압 환자에서 Amlodipine maleate와 AmIodipine besylate의 유효성 및 내약성 비교평가를 위한 8주간의 다기관 공동, 무작위배정, 이중맹검, 이중위약, 대조군 병행 제 3상 임상시험
A 8week, Multi-center, Randomized, Double blinded, Double dummy, Parallel-group Comparative Phase 3 Clinical trial to Assess the Efficacy and Safety of Amlodipine maleate Compared to Amlodipine besylate in Patients with Mild-to-moderate Hypertension
임상약리학회지 2005년 13권 1호 p.64 ~ p.83
이형돈(Lee Hyoung-Don) - 서울의료원 순환기내과
김석연(Kim Seok-Yeon) - 서울의료원 순환기내과
한봉준(Han Bong-Jun) - 성균관대학교 의과대학 순환기내과학교실
강형민(Kang Hyun-Min) - 성균관대학교 의과대학 순환기내과학교실
박재은(Park Jae-Eun) - 성균관대학교 의과대학 순환기내과학교실
강진호(Kang Jin-Ho) - 성균관대학교 의과대학 순환기내과학교실
김범수(Kim Bum-Soo) - 성균관대학교 의과대학 순환기내과학교실
성기철(Sung Ki-Chul) - 성균관대학교 의과대학 순환기내과학교실
김병진(Kim Byung-Jin) - 성균관대학교 의과대학 순환기내과학교실
김진우(Kim Jin-Woo) - 울산대학교 의과대학 강릉아산병원 순환기 내과
허승호(Hur Seung-Ho) - 계명대학교 의과대학 동산의료원 내과
김기식(Kim Ki-Sik) - 계명대학교 동산의료원 순환기내과
이인규(Lee In-Kyu) - 계명대학교 동산의료원 순환기내과
김혜순(Kim Hey-Soon) - 계명대학교 동산의료원 순환기내과
김미정(Kim Mi-Jung) - 계명대학교 동산의료원 순환기내과
김철민(Kim Chul-Min) - 가톨릭대학교 의과대학 성빈센트병원 순환기내과학교실
Abstract
Background & Objectives : Calcium channel blockers(CCB) have been used primary antihyperetensives. among them, second generation CCB, amlodipine besylate(Norvasc), has been used worldwide recent 10years because of it’’s high bioavailibility and long half life. but, non-besylate amlodipine such as amlodipine maleate has not been used even though it’’s many biochemical, pharmacological and toxicological information. so, we compared amlodipine besylate with amlodipne maleate in anti-hyperetensive activity and safety.
Methods :We used 8weeks, multi-center, randomized, double blinded, double dummy, parallel-group comparative phase 3 clinical trial to assess the efficacy and safety of amlodipine maleate compared to amlodipine besylate in patients with mild-to-moderate hypertension.
Results :In anti-hyperertensive efficacy, the mean declines in sDBP was 12.8{\pm}6.5mmHg vs 1l.5{pm}7.3mmHg in each cases. difference is 1.2mmHg, and this is meaningless statistically. In safety, there were several side effects such as rash, urticaria, headache, insomnia and so on. But, no severe side effects and statistically meaningful differences were noted in each cases. According to our study, there are little differences between amlodipine besylate and amlodipine maleate in efficacy and safety.
Conclusions :Besylate and maleate, are just carriers of amlodipine in the body. amlodipine itself acts on the net anti-hypertensive effect. so, we found that amlodipine besylate and amlodipine maleate show nearly same anti-hypertensive effect and safety regardless of their salt compounds.
키워드
KMID :
0391020050130010064
원문 및 링크아웃 정보
등재저널 정보
유효성결과(Recomendation)
There are little differences between amlodipine besylate and amlodipine maleate in efficacy and safety.