Buchumschlag

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

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....

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Bibliographische Detailangaben
Hauptverfasser: Mueller, Sebastian (VerfasserIn) , Luderer, Mathias (VerfasserIn) , Zhang, Doris (VerfasserIn) , Meulien, Didier (VerfasserIn) , Brach, Björn Steiniger (VerfasserIn) , Schou, Maiken Brix (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 12 November 2019
In: Alcohol and alcoholism
Year: 2020, Jahrgang: 55, Heft: 1, Pages: 63-70
ISSN:1464-3502
DOI:10.1093/alcalc/agz078
Online-Zugang:Verlag, Volltext: https://doi.org/10.1093/alcalc/agz078
Verlag, Volltext: https://academic.oup.com/alcalc/article-abstract/55/1/63/5622719
Volltext
Verfasserangaben:Sebastian Mueller, Mathias Luderer, Doris Zhang, Didier Meulien, Björn Steiniger Brach, Maiken Brix Schou
Beschreibung
Zusammenfassung: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.
Beschreibung:Gesehen am 08.02.2021
Beschreibung:Online Resource
ISSN:1464-3502
DOI:10.1093/alcalc/agz078

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