National Hospital Organization, Kurihama Medical and Addiction Center, Yokosuka, Japan.
Department of Clinical Management, Clinical Development Headquarters, Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan.
Psychiatry Clin Neurosci. 2020 Aug;74(8):431-438. doi: 10.1111/pcn.13017. Epub 2020 May 27.
The safety and efficacy of nalmefene in Japanese patients with high or very high World Health Organization drinking risk level of alcohol dependence were assessed in a multicenter, randomized, double-blind, placebo-controlled, phase 3 (lead-in) study. Here, the long-term safety and efficacy of nalmefene in an open-label extension of the lead-in study are presented.
Patients who completed the 24-week lead-in study were eligible for the extension study, where they were treated with nalmefene 20 mg as needed for 24 weeks. The long-term safety and efficacy of nalmefene 20 mg during the total 48-week period were evaluated. Treatment-emergent adverse events during the study period were recorded and change from baseline in the number of heavy drinking days and total alcohol consumption were calculated.
Overall, long-term nalmefene 20 mg was well tolerated; the main treatment-emergent adverse events reported in ≥5% of patients included nasopharyngitis (37.2%), nausea (36.5%), somnolence (21.2%), dizziness (16.8%), malaise (14.6%), and vomiting (12.4%). The number of heavy drinking days and total alcohol consumption decreased from baseline to 48 weeks (mixed model for repeated measures, least squares mean ± standard error, -15.09 ± 0.77 days/month and -53.20 ± 2.29 g/day, respectively) during the study.
This long-term evaluation in Japanese patients with high or very high drinking risk levels of alcohol dependence indicated that nalmefene was safe, well tolerated, and efficacious.
在一项多中心、随机、双盲、安慰剂对照的 3 期（导入期）研究中，评估纳美芬在日本高或极高世界卫生组织饮酒风险水平酒精依赖患者中的安全性和疗效。在此，介绍了导入期研究的开放标签扩展研究中纳美芬的长期安全性和疗效。
完成 24 周导入期研究的患者有资格参加扩展研究，在扩展研究中，他们按需接受纳美芬 20mg 治疗，为期 24 周。评估了在总共 48 周期间纳美芬 20mg 的长期安全性和疗效。记录了研究期间出现的治疗突发不良事件，并计算了从基线到第 48 周的重度饮酒天数和总酒精摄入量的变化。
总体而言，长期纳美芬 20mg 耐受性良好；报告发生率≥5%的主要治疗突发不良事件包括鼻咽炎（37.2%）、恶心（36.5%）、嗜睡（21.2%）、头晕（16.8%）、不适（14.6%）和呕吐（12.4%）。从基线到 48 周（混合模型重复测量，最小二乘均数±标准误差，-15.09±0.77 天/月和-53.20±2.29g/天），重度饮酒天数和总酒精摄入量均减少。
这项对日本高或极高饮酒风险水平酒精依赖患者的长期评估表明，纳美芬安全、耐受良好且有效。
