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dc.contributor.authorFitzgerald, Niamhen_UK
dc.contributor.authorAngus, Kathrynen_UK
dc.contributor.authorElders, Andrewen_UK
dc.contributor.authorde Andrade, Marisaen_UK
dc.contributor.authorRaistrick, Duncanen_UK
dc.contributor.authorHeather, Nicken_UK
dc.contributor.authorMcCambridge, Jimen_UK
dc.description.abstractBackground 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.en_UK
dc.publisherWiley-Blackwell on behalf of Society for the Study of Addictionen_UK
dc.relationFitzgerald 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.
dc.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.en_UK
dc.subjectbrief interventionen_UK
dc.subjecttrial regulationen_UK
dc.subjectvested interestsen_UK
dc.titleWeak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchersen_UK
dc.typeJournal Articleen_UK
dc.type.statusVoR - Version of Recorden_UK
dc.contributor.funderMedical Research Councilen_UK
dc.contributor.affiliationInstitute for Social Marketingen_UK
dc.contributor.affiliationInstitute for Social Marketingen_UK
dc.contributor.affiliationGlasgow Caledonian Universityen_UK
dc.contributor.affiliationUniversity of Edinburghen_UK
dc.contributor.affiliationLeeds Addiction Uniten_UK
dc.contributor.affiliationNorthumbria Universityen_UK
dc.contributor.affiliationUniversity of Yorken_UK
dc.description.refREF Compliant by Deposit in Stirling's Repositoryen_UK
dc.relation.funderprojectThe Uk Centre for Tobacco & Alcohol Studies (UKCTAS)en_UK
Appears in Collections:Faculty of Health Sciences and Sport Journal Articles

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