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Tolerability and Effectiveness of (S)-Amlodipine Compared With Racemic Amlodipine in Hypertension: A Systematic Review and Meta-Analysis
Liu, Fang1; Qiu, Meng2; Zhai, Suo-Di1
关键词(s)-amlodipine Hypertension Systematic Review
刊名CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL
2010-02-01
DOI10.1016/j.curtheres.2010.02.005
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
引用统计
被引频次:11[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/56150
专题北京大学第三临床医学院_药剂科
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
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GB/T 7714
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.
APA Liu, Fang,Qiu, Meng,&Zhai, Suo-Di.(2010).Tolerability and Effectiveness of (S)-Amlodipine Compared With Racemic Amlodipine in Hypertension: A Systematic Review and Meta-Analysis.CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL,71(1),1-29.
MLA Liu, Fang,et al."Tolerability and Effectiveness of (S)-Amlodipine Compared With Racemic Amlodipine in Hypertension: A Systematic Review and Meta-Analysis".CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL 71.1(2010):1-29.
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