Reynaud Michel, Aubin Henri-Jean, Trinquet Francoise, Zakine Benjamin, Dano Corinne, Dematteis Maurice, Trojak Benoit, Paille Francois, Detilleux Michel
Actions Addictions-Saint Joseph Hospital, 185 rue Raymond Losserand, 75014 Paris, France.
Department of Addiction Medicine, University Hospital Paris Sud, Villejuif, France.
Alcohol Alcohol. 2017 Jul 1;52(4):439-446. doi: 10.1093/alcalc/agx030.
Alcohol dependence is a major public health issue with a need for new pharmacological treatments. The ALPADIR study assessed the efficacy and safety of baclofen at the target dose of 180 mg/day for the maintenance of abstinence and the reduction in alcohol consumption in alcohol-dependent patients.
Three hundred and twenty adult patients (158 baclofen and 162 placebo) were randomized after alcohol detoxification. After a 7-week titration, the maintenance dose was provided for 17 weeks, then progressively decreased over 2 weeks before stopping.
The percentage of abstinent patients during 20 consecutive weeks (primary endpoint) was low (baclofen: 11.9%; placebo: 10.5%) and not significantly different between groups (OR 1.20; 95%CI: 0.58 to 2.50; P = 0.618). A reduction in alcohol consumption was observed from month 1 in both groups, but the difference of 10.9 g/day at month 6 between groups, in favour of baclofen, was not statistically significant (P = 0.095). In a subgroup of patients with high drinking risk level at baseline, the reduction was greater with a difference at month 6 of 15.6 g/day between groups in favour of baclofen (P = 0.089). The craving assessed with Obsessive-Compulsive Drinking Scale significantly decreased in the baclofen group (P = 0.017). No major safety concern was observed.
This study did not demonstrate the superiority of baclofen in the maintenance of abstinence at the target dose of 180 mg/day. A tendency towards a reduction in alcohol consumption and a significantly decreased craving were observed in favour of baclofen.
Baclofen was assessed versus placebo for maintenance of abstinence and reduction in alcohol consumption in alcohol-dependent patients. This study did not demonstrate the superiority of baclofen in the maintenance of abstinence. A tendency towards a reduction in alcohol consumption and a significantly decreased craving were observed in favour of baclofen.
酒精依赖是一个重大的公共卫生问题，需要新的药物治疗方法。ALPADIR研究评估了巴氯芬在目标剂量180毫克/天对酒精依赖患者维持戒酒和减少酒精摄入量的疗效及安全性。
320名成年患者（158名服用巴氯芬，162名服用安慰剂）在酒精解毒后被随机分组。经过7周的滴定，维持剂量服用17周，然后在停药前2周逐渐减少。
连续20周戒酒患者的百分比（主要终点）较低（巴氯芬组：11.9%；安慰剂组：10.5%），两组间无显著差异（比值比1.20；95%置信区间：0.58至2.50；P = 0.618）。两组从第1个月起酒精摄入量均有减少，但第6个月时两组间有利于巴氯芬的每天10.9克的差异无统计学意义（P = 0.095）。在基线饮酒风险水平高的患者亚组中，减少幅度更大，第6个月时两组间有利于巴氯芬的每天15.6克的差异（P = 0.089）。用强迫性饮酒量表评估的渴望在巴氯芬组中显著降低（P = 0.017）。未观察到重大安全问题。
本研究未证明巴氯芬在180毫克/天的目标剂量下维持戒酒方面具有优越性。观察到有利于巴氯芬的酒精摄入量减少趋势和渴望显著降低。
评估了巴氯芬与安慰剂对酒精依赖患者维持戒酒和减少酒精摄入量的作用。本研究未证明巴氯芬在维持戒酒方面具有优越性。观察到有利于巴氯芬的酒精摄入量减少趋势和渴望显著降低。
