Open-label Study with Nalmefene as Needed Use in Alcohol-Dependent Patients with Evidence of Elevated Liver Stiffness and/or Hepatic Steatosis.

Autor:	Mueller S; Department of Medicine and Centre for Alcohol Research, Salem Medical Centre, University of Heidelberg, Zeppelinstraße 11-33, 69121 Heidelberg, Germany., Luderer M; Department of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, J 5 68159 Mannheim, Germany.; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe University, Heinrich-Hoffmann-Str. 10 60528 Frankfurt/Main, Germany., Zhang D; H. Lundbeck A/S, Ottiliavej 9 2500 Valby Denmark., Meulien D; H. Lundbeck A/S, Ottiliavej 9 2500 Valby Denmark., Brach BS; UCB Biopharma S.P.R.L., Allée de la Recherche 60 1070 Anderlecht, Belgium., Schou MB; H. Lundbeck A/S, Ottiliavej 9 2500 Valby Denmark.
Jazyk:	angličtina
Zdroj:	Alcohol and alcoholism (Oxford, Oxfordshire) [Alcohol Alcohol] 2020 Feb 07; Vol. 55 (1), pp. 63-70.
DOI:	10.1093/alcalc/agz078
Abstrakt:	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. (© The Author(s) 2019. Medical Council on Alcohol and Oxford University Press. All rights reserved.)
Databáze:	MEDLINE
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