Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers

Niamh Fitzgerald; Kathryn Angus; Andrew Elders; Marisa de Andrade; Duncan Raistrick; Jim McCambridge; Nick Heather

doi:10.1111/add.13438

Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers

Niamh Fitzgerald, Kathryn Angus, Andrew Elders, Marisa de Andrade, Duncan Raistrick, Jim McCambridge, Nick Heather

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Abstract

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. 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.

Original language	English
Pages (from-to)	1477–1487
Number of pages	11
Journal	Addiction
Volume	111
Issue number	8
Early online date	5 Jun 2016
DOIs	https://doi.org/10.1111/add.13438
Publication status	Published - Jul 2016

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Keywords

addiction
alcohol
brief intervention
nalmefene
trial regulation
vested interests

Cite this

Fitzgerald, N., Angus, K., Elders, A., de Andrade, M., Raistrick, D., McCambridge, J., & Heather, N. (2016). Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers. Addiction, 111(8), 1477–1487. https://doi.org/10.1111/add.13438

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abstract = "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. 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.",

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author = "Niamh Fitzgerald and Kathryn Angus and Andrew Elders and {de Andrade}, Marisa and Duncan Raistrick and Jim McCambridge and Nick Heather",

note = "Paid open option for this journal (Wiley) Funders in Acknowledgements: The authors would like to acknowledge the helpful input on earlier drafts made by the anonymous peer reviewers and colleagues including, but not limited to: Srinivasa Vittal Katikireddi, James Nicholls, Colin Angus, James Morris and Peter Rice. N.F. and K.A. are employed by the Institute for Social Marketing, which is part of the UK Centre for Tobacco and Alcohol Studies (www.ukctas.ac.uk). Funding for UKCTAS from the British Heart Foundation, Cancer Research UK, the Economic and Social Research Council, the Medical Research Council and the National Institute of Health Research, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged. ",

year = "2016",

month = jul,

doi = "10.1111/add.13438",

language = "English",

volume = "111",

pages = "1477–1487",

journal = "Addiction",

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T1 - Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers

AU - Fitzgerald, Niamh

AU - Angus, Kathryn

AU - Elders, Andrew

AU - de Andrade, Marisa

AU - Raistrick, Duncan

AU - McCambridge, Jim

AU - Heather, Nick

N1 - Paid open option for this journal (Wiley) Funders in Acknowledgements: The authors would like to acknowledge the helpful input on earlier drafts made by the anonymous peer reviewers and colleagues including, but not limited to: Srinivasa Vittal Katikireddi, James Nicholls, Colin Angus, James Morris and Peter Rice. N.F. and K.A. are employed by the Institute for Social Marketing, which is part of the UK Centre for Tobacco and Alcohol Studies (www.ukctas.ac.uk). Funding for UKCTAS from the British Heart Foundation, Cancer Research UK, the Economic and Social Research Council, the Medical Research Council and the National Institute of Health Research, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged.

PY - 2016/7

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N2 - 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. 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.

AB - 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. 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.

KW - addiction

KW - alcohol

KW - brief intervention

KW - nalmefene

KW - trial regulation

KW - vested interests

U2 - 10.1111/add.13438

DO - 10.1111/add.13438

M3 - Article

VL - 111

SP - 1477

EP - 1487

JO - Addiction

JF - Addiction

SN - 0965-2140

IS - 8

ER -

Documents and Links

10.1111/add.13438

Fitzgerald, N et al (2016) Addiction journal article
© 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.
Final published version, 262 KBLicence: CC BY