Di Nicola Marco, De Filippis Sergio, Martinotti Giovanni, De Risio Luisa, Pettorruso Mauro, De Persis Simone, Maremmani Angelo Giovanni Icro, Maremmani Icro, di Giannantonio Massimo, Janiri Luigi
Institute of Psychiatry and Psychology, Fondazione Policlinico Universitario "A. Gemelli", Università Cattolica del Sacro Cuore, Rome, Italy.
Psychiatric Clinic "Von Siebenthal", Rome, Italy.
Adv Ther. 2017 Jul;34(7):1636-1649. doi: 10.1007/s12325-017-0546-3. Epub 2017 May 24.
Nalmefene is the first drug to be approved for reducing alcohol consumption in alcohol use disorder (AUD) patients at high drinking risk. In real-world settings, there is a high prevalence of concurrent psychiatric disorders in AUD subjects, with associated increased morbidity and worse prognosis. This study evaluated the use of nalmefene in AUD patients with stabilized psychiatric comorbidity previously treated unsuccessfully for alcohol dependence, and assessed craving reduction and safety.
Sixty-five AUD outpatients treated with as-needed 18 mg nalmefene for 24 weeks were included. Primary outcome measures were: changes in heavy drinking days (HDDs) and total alcohol consumption (TAC, g/day). Secondary outcome measures were: changes in drinking risk level and craving (obsessive-compulsive drinking scale and visual analogue scale for craving).
Forty-two AUD subjects (64.6%) had one or more stabilized psychiatric comorbidity. There was a significant reduction in HDDs, TAC and craving measures (p < 0.001), with no differences between subjects with and without psychiatric comorbidity. Nalmefene was safe and well tolerated in all patients.
As-needed nalmefene reduced drinking and craving in AUD subjects with and without psychiatric comorbidity. These findings suggest that nalmefene is a valid therapeutic option in real-world clinical settings, where comorbid conditions are common, and has the potential to engage AUD patients who may otherwise not have sought help.
Lundbeck Italia S.P.A.
纳美芬是首个被批准用于降低酒精使用障碍（AUD）高饮酒风险患者酒精摄入量的药物。在现实环境中，AUD患者中并发精神障碍的患病率很高，且发病率增加，预后更差。本研究评估了纳美芬在先前酒精依赖治疗失败且精神合并症已稳定的AUD患者中的应用，并评估了其对渴求的降低作用及安全性。
纳入65例按需服用18毫克纳美芬治疗24周的AUD门诊患者。主要结局指标为：重度饮酒天数（HDDs）和总酒精摄入量（TAC，克/天）的变化。次要结局指标为：饮酒风险水平和渴求（强迫性饮酒量表和渴求视觉模拟量表）的变化。
42例（64.6%）AUD患者有一种或多种稳定的精神合并症。HDDs、TAC和渴求指标均显著降低（p < 0.001），有精神合并症和无精神合并症的患者之间无差异。纳美芬在所有患者中均安全且耐受性良好。
按需服用纳美芬可降低有或无精神合并症的AUD患者的饮酒量和渴求感。这些发现表明，在共病情况常见的现实临床环境中，纳美芬是一种有效的治疗选择，并且有可能让那些原本可能不会寻求帮助的AUD患者接受治疗。
灵北意大利股份公司
