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学科主题: 临床医学
题名:
Tolerability and Effectiveness of (S)-Amlodipine Compared With Racemic Amlodipine in Hypertension: A Systematic Review and Meta-Analysis
作者: Liu, Fang1; Qiu, Meng2; Zhai, Suo-Di1
关键词: (S)-amlodipine ; hypertension ; systematic review
刊名: CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL
发表日期: 2010-02-01
DOI: 10.1016/j.curtheres.2010.02.005
卷: 71, 期:1, 页:1-29
收录类别: SCI
文章类型: Review
WOS标题词: Science & Technology
类目[WOS]: Medicine, Research & Experimental ; Pharmacology & Pharmacy
研究领域[WOS]: Research & Experimental Medicine ; Pharmacology & Pharmacy
关键词[WOS]: NITRIC-OXIDE ; CALCIUM ; FORMULATION ; ENANTIOMER
英文摘要:

BACKGROUND: Amlodipine is a calcium channel blocker prescribed for the management of angina and hypertension. As a racemic mixture, amlodipine contains (R)- and (S)-amlodipine isomers, but only (S)-amlodipine as the active moiety possesses therapeutic activity. Based on pharmacologic research, it remains uncertain if (S)-amlodipine alone has similar efficacy and fewer associated adverse events (AEs) compared with the racemic mixtures.

OBJECTIVE: The aim of this systematic review and meta-analysis was to determine the effectiveness and tolerability of (S)-amlodipine compared with that of racemic amlodipine.

METHODS: A systematic literature search was performed using MEDLINE (1966-2009), EMBASE (1966-2009), the Cochrane Central Register of Controlled Trials (issue 3, 2009), the Chinese Biomedical Database (1978-2009), and the China National Knowledge Internet (1980-2009). All randomized controlled trials (RCTs) comparing (S)-amlodipine 2.5 mg and racemic amlodipine 5.0 mg in the treatment of hypertension were included in the review. The outcome measures to be collected were cardiovascular events, systolic blood pressure (SBP), diastolic BP (DBP), and AEs. Quality assessments of clinical trials were conducted using a modified Jadad Scale, with trials being rated as low quality (score 0-3) or high quality (score 4-7). Meta-analysis of the included studies was performed using RevMan software.

RESULTS: Of the 229 references identified, 214 were excluded after screening the titles, abstracts, or full texts. Fifteen RCTs were included, of which 13 were in Chinese and 2 in English. Based on the Jadad Scale score, 3 of the RCTs were classified as high quality (score 5 or 6) and the remaining 12 as low quality (score 1-3). None of the trials evaluated cardiovascular events beyond 40 weeks. Meta-analysis of the 15 trials indicated that (S)-amlodipine was not significantly different from racemic amlodipine in the effect on BP. When only high-quality studies were Included, after 4 weeks′ treatment, the weighted mean difference (WMD) of SBP and DBP decrease (I study) was -2.84 (95% Cl, -6.42 to 0.74) with (S)-amlodipine and -1.71 (95% CI, -3-48 to 0.06) with racemic amlodipine. After 8 weeks′ treatment, the WMD of SBP and DBP decrease (2 studies) was -1.13 (95% CI, -5.29 to 3.03) and -1.34 (9596 Cl, -2.67 to -0.01), respectively. The risk difference (RD) for the number of patients who experienced AEs with (S)-amlodipine and racemic amlodipine was found to be -0.04 (95% CI, -0-06 to -0.02). When all the trials were included, (s)-amlodipine treatment was associated with significantly less edema than racemic amlodipine (RD, -0.02; 95176 CI, -0-03 to 0.00); however, when only high-quality studies (2 studies) were included, no difference was found between the 2 groups (RD, 0.01; 95% CI, -0.02 to 0.03). One high-quality study found significant differences in increases in aspartate and alanine aminotransferase activities in the 2 groups (RD, 0.08; 95% CI, 0.01 to 0.05). No significant differences between the 2 groups were found in the incidence of headache (RD, 0.00; 9596 Cl, -0.02 to 0.01) or flushing (RD, -0.01; 95% CI, -0.02 to 0.00).

CONCLUSIONS: The majority of the clinical trials comparing (S)-amlodipine and racemic amlodipine treatment were low quality (12/15 [80%]). According to the limited evidence, there were no significant differences between (S)-amlodipine 2.5 mg and racemic amlodipine 5.0 mg in controlling BP. When all the trials were considered, (S)-amlodipine treatment was associated with significantly less edema than racemic amlodipine; however, when only high-quality trials were included, no significant difference was found. More long-term, high-quality RCTs with cardiovascular events as the primary outcome are needed to compare the safety and efficacy of (S)-amlodipine and racemic amlodipine. (Curr Ther Res Clin Exp. 2010;71:1-29) (C) 2010 Excerpta Medica Inc.

语种: 英语
WOS记录号: WOS:000275883900001
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/56150
Appears in Collections:北京大学第三临床医学院_药剂科_期刊论文

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作者单位: 1.Peking Univ, Hosp 3, Dept Pharm, Beijing 100191, Peoples R China
2.Peking Univ, Hosp 3, Dept Geriatr, Beijing 100191, Peoples R China

Recommended Citation:
Liu, Fang,Qiu, Meng,Zhai, Suo-Di. Tolerability and Effectiveness of (S)-Amlodipine Compared With Racemic Amlodipine in Hypertension: A Systematic Review and Meta-Analysis[J]. CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL,2010,71(1):1-29.
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