Open-label study with Nalmefene as needed use in alcohol-dependent patients with evidence of elevated liver stiffness and/or hepatic steatosis

• Verfasst von: Mueller, Sebastian [VerfasserIn]
• Verfasst von: Luderer, Mathias [VerfasserIn]
• Verfasst von: Zhang, Doris [VerfasserIn]
• Verfasst von: Meulien, Didier [VerfasserIn]
• Verfasst von: Brach, Björn Steiniger [VerfasserIn]
• Verfasst von: Schou, Maiken Brix [VerfasserIn]
• Titel: Open-label study with Nalmefene as needed use in alcohol-dependent patients with evidence of elevated liver stiffness and/or hepatic steatosis
• Verf.angabe: Sebastian Mueller, Mathias Luderer, Doris Zhang, Didier Meulien, Björn Steiniger Brach, Maiken Brix Schou
• E-Jahr: 2020
• Jahr: 12 November 2019
• Jahr des Originals: 2020
• Umfang: 8 S.
• Fussnoten: Gesehen am 08.02.2021
• Titel Quelle: Enthalten in: Alcohol and alcoholism
• Ort Quelle: Oxford : Oxford Univ. Press, 1963
• Jahr Quelle: 2020
• Band/Heft Quelle: 55(2020), 1, Seite 63-70
• ISSN Quelle: 1464-3502
• DOI: doi:10.1093/alcalc/agz078
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: Alcohol Drinking
• Sach-SW: Alcoholism
• Sach-SW: Elasticity
• Sach-SW: Elasticity Imaging Techniques
• Sach-SW: Fatty Liver
• Sach-SW: Female
• Sach-SW: Humans
• Sach-SW: Male
• Sach-SW: Middle Aged
• Sach-SW: Naltrexone
• Sach-SW: Narcotic Antagonists
• Sach-SW: Treatment Outcome
• K10plus-PPN: 1747722340

Abstract

AIMS: This open-label study in patients with alcohol dependence and evidence of elevated liver stiffness and/or hepatic steatosis was designed to explore the efficacy of nalmefene (18 mg) in reducing alcohol consumption and its subsequent effects on a variety of clinically relevant liver parameters. METHODS: Adult patients with a diagnosis of alcohol dependence and evidence of elevated liver stiffness and/or hepatic steatosis (liver stiffness >6 kPa or controlled attenuation parameter (CAP) >215 dB/m as measured by transient elastography) were recruited at two study sites in Germany. During the 12-week treatment period, patients were instructed to take nalmefene each day they perceived a risk of drinking alcohol. RESULTS: All 45 enrolled patients took at least one dose of nalmefene and 39 completed the study. After 12 weeks of study treatment with nalmefene patients showed a reduction in alcohol consumption of -13.5 days/month heavy drinking days and -45.8 g/day total alcohol consumption. Most liver parameters showed modest changes at Week 12; there was a 13% decrease in liver stiffness and 10% reduction in CAP values. Results indicated non-significant negative associations between alcohol consumption and liver stiffness and/or CAP over this 12-week study. Nalmefene was generally well tolerated, and most adverse events were mild or moderate, the most frequent being dizziness. CONCLUSIONS: Patients treated with nalmefene for 12 weeks had reductions in alcohol consumption by ~50% relative to baseline and showed trends to improvement in liver stiffness and CAP.