Acamprosate for Alcohol Dependence: A Sex-Specific Meta-Analysis Based on Individual Patient Data
Acamprosate for Alcohol Dependence: A Sex-Specific Meta-Analysis Based on Individual Patient Data
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DOI：
10.1111/j.1530-0277.2011.01616.x
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发表时间：
2012-03-01
影响因子：
3.2
通讯作者：
Lehert, Philippe
中科院分区：
文献类型：
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作者：
Mason, Barbara J.;Lehert, Philippe
背景：目前尚不清楚女性服用氨基己酸酯是否能获得与男性类似的益处，并具有类似的安全性和耐受性。氨基己酸酯是一种广泛用于维持酒精依赖戒断的处方药。本研究的目的是评估氨基己酸酯在治疗男性和女性酒精依赖患者的有效性、安全性和耐受性方面的性别差异。方法：基于个体患者数据(IPD)进行性别特异性荟萃分析。数据来自双盲随机对照试验，对接受口服氨基己酸酯或安慰剂的酒精依赖患者进行定量饮酒措施。资料来源包括PubMed、心理学信息和Cochrane电子数据库；从检索到的文章和专业会议上的演示文稿中获得参考列表；以及直接访问提供IPD的作者和公司。结果：个人记录来自1,317名女性和4,794名男性，他们参与了在18个国家进行的22项合格研究。IPD Meta分析发现，与安慰剂相比，阿卡米松在所有4个疗效终点都有显著的益处：戒酒天数百分比增加10.4%(95%可信区间7.1至13.7，p<；0.001)，戒酒天数增加11.0%(7.4%至14.6，p<；0.001)，优势比为1.9(1.6p<；2.2p<；；在研究期间，完全戒酒率和不酗酒比率的优势比为1.9%(1.6%对2.3%，p<；0.001)。与安慰剂相比，阿卡米松的治疗完成率(p=0.004)和服药依从性(p<；0.001)也显著更高。男性和女性在氨基己酸酯的有效性、安全性或耐受性的任何衡量标准上没有差异。结论：这项针对性别的IPD荟萃分析提供了证据，表明与安慰剂相比，氨基己酸酯在提高酒精依赖女性和男性的戒酒率和不酗酒方面具有显著效果。此外，在女性和男性中，氨基己酸酯的治疗完成率和服药依从性都比安慰剂高得多，并且具有类似的安全性和耐受性。
Background: It is unknown whether women derive comparable benefits and have a similar safety and tolerability profile as men from acamprosate, a widely prescribed drug for the maintenance of abstinence in alcohol dependence. The objective of this study was to assess sex-specific differences in the efficacy, safety, and tolerability of acamprosate in the treatment of women and men with alcohol dependence.Methods: A sex- specific meta-analysis was conducted based on individual patient data (IPD). Data were obtained from double-blind, randomized controlled trials with quantitative drinking measures in patients with alcohol dependence receiving oral acamprosate or placebo. Sources included PubMed, PsychInfo, and Cochrane electronic databases; reference lists from retrieved articles and presentations at professional meetings; and direct access to authors and companies who provided IPD.Results: Individual records were obtained from 1,317 women and 4,794 men who participated in 22 eligible studies conducted in 18 countries. IPD meta-analyses found a significant beneficial effect of acamprosate relative to placebo across all 4 efficacy end points: an incremental gain of 10.4% (95% CI 7.1 to 13.7, p < 0.001) in percentage of abstinent days, an incremental gain of 11.0% (7.4 to 14.6, p < 0.001) in percentage of no heavy drinking days, an odds ratio of 1.9 (1.6 to 2.2, p < 0.001) for rate of complete abstinence, and an odds ratio of 1.9 (1.6 to 2.3, p < 0.001) for rate of no heavy drinking, over the study duration. Acamprosate was also associated with significantly higher rates of treatment completion (p = 0.004) and medication compliance (p < 0.001) than placebo. Men and women did not differ on any measure of acamprosate efficacy, safety, or tolerability.Conclusions: This sex-specific IPD meta-analysis provides evidence that acamprosate has a significant effect compared with placebo in improving rates of abstinence and no heavy drinking in both women and men with alcohol dependence. Further, acamprosate was associated with significantly higher rates of treatment completion and medication compliance than placebo among both women and men and had a comparable safety and tolerability profile.