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

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

Research output: Contribution to journalArticle

62 Downloads (Pure)

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 languageEnglish
Pages (from-to)1477–1487
Number of pages11
JournalAddiction
Volume111
Issue number8
Early online date5 Jun 2016
DOIs
Publication statusPublished - Jul 2016

Fingerprint

National Institutes of Health (U.S.)
Research Personnel
Delivery of Health Care
Alcoholism
Registries
Clinical Trials
nalmefene

Keywords

  • addiction
  • alcohol
  • brief intervention
  • nalmefene
  • trial regulation
  • vested interests

Cite this

Fitzgerald, N., Elders, A., Angus, K., de Andrade, M., Raistrick, D., & McCambridge, J. (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
Fitzgerald, Niamh ; Elders, Andrew ; Angus, Kathryn ; de Andrade, Marisa ; Raistrick, Duncan ; McCambridge, Jim. / Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers. In: Addiction. 2016 ; Vol. 111, No. 8. pp. 1477–1487.
@article{047df9365f1b4b00a041f84fcbef6b23,
title = "Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers",
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.",
keywords = "addiction, alcohol, brief intervention, nalmefene, trial regulation, vested interests",
author = "Niamh Fitzgerald and Andrew Elders and Kathryn Angus and {de Andrade}, Marisa and Duncan Raistrick and Jim McCambridge",
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 = "7",
doi = "10.1111/add.13438",
language = "English",
volume = "111",
pages = "1477–1487",
journal = "Addiction",
issn = "0965-2140",
number = "8",

}

Fitzgerald, N, Elders, A, Angus, K, de Andrade, M, Raistrick, D & McCambridge, J 2016, 'Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers', Addiction, vol. 111, no. 8, pp. 1477–1487. https://doi.org/10.1111/add.13438

Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers. / Fitzgerald, Niamh; Elders, Andrew; Angus, Kathryn; de Andrade, Marisa; Raistrick, Duncan; McCambridge, Jim.

In: Addiction, Vol. 111, No. 8, 07.2016, p. 1477–1487.

Research output: Contribution to journalArticle

TY - JOUR

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

AU - Fitzgerald, Niamh

AU - Elders, Andrew

AU - Angus, Kathryn

AU - de Andrade, Marisa

AU - Raistrick, Duncan

AU - McCambridge, Jim

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

Y1 - 2016/7

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 -