1. Efficacy and safety of sodium oxybate in alcohol-dependent patients with a very high drinking risk level
- Author
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Van Den Brink, Wim, Addolorato, Giovanni, Aubin, Henri-Jean, Benyamina, Amine, Caputo, Fabio, Dematteis, Maurice, Gual, Antoni, Lesch, Otto-Michael, Mann, Karl, Maremmani, Icro, Nutt, David, Paille, François, Perney, Pascal, Rehm, Jurgen, Reynaud, Michel, Simon, Nicolas, Söderpalm, Bo, Mann, Wolfgang, Walter, Henriette, Mann, Rainer, ANS - Compulsivity, Impulsivity & Attention, Adult Psychiatry, Department of Psychiatry [Amsterdam, The Netherlands], Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), Department of Internal Medicine, Gastroenterology and Hepatology [Rome, Italy] (Alcohol Use Disorder Unit), Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma] (Unicatt)-A. Gemelli Hospital [Rome, Italy], Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Paul Brousse, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse, Université Paris-Sud - Paris 11 (UP11), Centre de recherche et de traitement de la toxicomanie [AP-HP Hôpital Paul Brousse], Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse, Institute of Internal Medicine, Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma] (Unicatt), Centre Hospitalier Universitaire [Grenoble] (CHU), Alcohol Unit, Neurosciences Institute, Hospital Clinic Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), University of Vienna [Vienna], Heidelberg University, University of Pisa - Università di Pisa, Department of Experimental Psychology, University of Oxford-University of Oxford, Imperial College London, Université de Lorraine (UL), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Hôpital Universitaire de Réadaptation, de Rééducation et d'Addictologie du CHU de Nîmes [Grau-du-Roi] (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Public Health and Regulatory Policies, Centre for Addiction and Mental Health [Toronto] (CAMH), Troubles du comportement alimentaire de l'adolescent (UMR_S 669), Université Paris-Sud - Paris 11 (UP11)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris-Sud - Paris 11 - Faculté des Sciences (UP11 UFR Sciences), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Section of Psychiatry and Neurochemistry [Gothenburg, Sweden] (Institute of Neuroscience and Physiology), University of Gothenburg (GU)-Sahlgrenska Academy at University of Gothenburg [Göteborg], Heidelberg University Hospital [Heidelberg], D&A Pharma supported an Expert Opinion Dossier written by all listed authors with the exception of WHS., Lissalde, Claire, Catholic University of Rome-A. Gemelli Hospital [Rome, Italy], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Hôpital Paul Brousse-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11), Catholic University of Rome, University of Pisa [Italy], University of Oxford [Oxford]-University of Oxford [Oxford], and Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11)
- Subjects
Adult ,Male ,Adolescent ,Settore MED/12 - GASTROENTEROLOGIA ,alcohol dependence ,heavy drinking ,drinking risk level ,NO ,nalrexone ,Young Adult ,acamprosate ,acamprosate, nalrexone, nalmefene, heavy drinking ,Secondary Prevention ,Humans ,acamprosate, nalrexone, nalmefene, heavy drinking, alcohol dependence, alcoholism, drinking risklevel, gamma-hydroxybutyric acid, GHB, sodium oxybate ,drinking risklevel ,Clinical Trials as Topic ,alcoholism ,Middle Aged ,nalmefene ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,gamma-hydroxybutyric acid ,Female ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,GHB ,sodium oxybate ,Alcohol Deterrents - Abstract
International audience; Medication development for alcohol relapse prevention or reduction of consumption is highly challenging due to meth-odological issues of pharmacotherapy trials. Existing approved medications are only modestly effective with many patients failing to benefit from these therapies. Therefore, there is a pressing need for other effective treatments with a different mechanism of action, especially for patients with very high (VH) drinking risk levels (DRL) because this is the most severely affected population of alcohol use disorder patients. Life expectancy of alcohol-dependent patients with a VH DRL is reduced by 22 years compared with the general population and approximately 90 000 alcohol-dependent subjects with a VH DRL die prematurely each year in the EU (Rehm et al. 2018). A promising new medication for this population is sodium oxybate, a compound that acts on GABA B receptors and extrasynaptic GABA A receptors resulting in alcohol-mimetic effects. In this article, a European expert group of alcohol researchers and clini-cians summarizes data (a) from published trials, (b) from two new-as yet unpublished-large clinical trials (GATE 2 (n = 314) and SMO032 (n = 496), (c) from post hoc subgroup analyses of patients with different WHO-defined DRLs and (d) from multiple meta-analyses. These data provide convergent evidence that sodium oxybate is effective especially in a subgroup of alcohol-dependent patients with VH DRLs. Depending on the study, abstinence rates are increased up to 34 percent compared with placebo with risk ratios up to 6.8 in favor of sodium oxybate treatment. These convergent data are supported by the clinical use of sodium oxybate in Austria and Italy for more than 25 years. Sodium oxybate is the sodium salt of γ-hydroxybutyric acid that is also used as a recreational (street) drug suggestive of abuse potential. However, a pharmacovigilance database of more than 260 000 alcohol-dependent patients treated with sodium oxybate reported very few adverse side effects and only few cases of abuse. We therefore conclude that sodium oxybate is an effective, well-tolerated and safe treatment for withdrawal and relapse prevention treatment, especially in alcohol-dependent patients with VH DRL.
- Published
- 2018
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