Fitzgerald, Niamh, Angus, Kathryn, Elders, Andrew et al. (4 more authors) (2016) Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers. Addiction. pp. 1477-1487. ISSN 1360-0443
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 of a priori outcome measures and sensitivity analyses, use of post-hoc sample 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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2016 The Authors. |
Keywords: | Journal Article |
Dates: |
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Institution: | The University of York |
Academic Units: | The University of York > Faculty of Sciences (York) > Health Sciences (York) |
Depositing User: | Pure (York) |
Date Deposited: | 22 Jun 2017 09:45 |
Last Modified: | 16 Oct 2024 13:51 |
Published Version: | https://doi.org/10.1111/add.13438 |
Status: | Published |
Refereed: | Yes |
Identification Number: | 10.1111/add.13438 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:118143 |
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