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Appears in Collections:Faculty of Health Sciences and Sport Journal Articles
Peer Review Status: Refereed
Title: Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers
Author(s): Fitzgerald, Niamh
Angus, Kathryn
Elders, Andrew
de Andrade, Marisa
Raistrick, Duncan
Heather, Nick
McCambridge, Jim
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Keywords: Addiction
brief intervention
trial regulation
vested interests
Issue Date: Aug-2016
Date Deposited: 6-Jun-2016
Citation: Fitzgerald N, Angus K, Elders A, de Andrade M, Raistrick D, Heather N & McCambridge J (2016) Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers. Addiction, 111 (8), pp. 1477-1487.
Abstract: Background and aims  Nalmefene has been approved in Europe for the treatment of alcohol dependence and subsequently recommended by the UK National Institute for Health and Care Excellence (NICE). This study examines critically the evidence base underpinning both decisions and the issues arising.  Methods  Published studies of nalmefene were identified through a systematic search, with documents from the European Medicines Agency, the NICE appraisal and public clinical trial registries also examined to identify methodological issues.  Results  Efficacy data used to support the licensing of nalmefene suffer from risk of bias due to lack of specification ofa priorioutcome measures and sensitivity analyses, use ofpost-hocsample refinement and the use of inappropriate comparators. Despite this evidence for the efficacy of nalmefene in reducing alcohol consumption in those with alcohol dependence is, at best, modest, and of uncertain significance to individual patients. The relevance of existing trial data to routine primary care practice is doubtful.  Conclusions  Problems with the registration, design, analysis and reporting of clinical trials of nalmefene did not prevent it being licensed and recommended for treating alcohol dependence. This creates dilemmas for primary care clinicians and commissioning organisations where nalmefene has been heavily promoted, and poses wider questions about the effectiveness of the medicines regulation system and how to develop the alcohol treatment evidence base.
DOI Link: 10.1111/add.13438
Rights: © 2016 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
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