Risks and Benefits of Nalmefene in the Treatment of Adult Alcohol Dependence: A Systematic Literature Review and Meta-Analysis of Published and Unpublished Double-Blind Randomized Controlled Trials

PLoS Medicine

Volumn 12, Issue 12, 2015, Pages

  Palpacuer, Clément ^a   Laviolle, Bruno ^a,b   Boussageon, Rémy ^c   Reymann, Jean Michel ^a,b   Bellissant, Eric ^a,b   Naudet, Florian ^a,b  

^a RENNES UNIVERSITY HOSPITAL   (France)

^b UNIVERSITÉ DE RENNES 1   (France)

^c UNIVERSITÉ DE POITIERS   (France)

Author keywords

[No Author keywords available]

Indexed keywords

NALMEFENE; PLACEBO; NALTREXONE; NARCOTIC ANTAGONIST;

ADULT; ALCOHOL ABUSE; ALCOHOL CONSUMPTION; ALCOHOLISM; ARTICLE; CLINICAL GLOBAL IMPRESSION SCALE; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; EUROPEAN MEDICINES AGENCY; HUMAN; INFORMATION RETRIEVAL; META ANALYSIS; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK; SENSITIVITY ANALYSIS; SHORT FORM 36; SYSTEMATIC REVIEW (TOPIC); ANALOGS AND DERIVATIVES; RISK ASSESSMENT; TREATMENT OUTCOME;

ALCOHOLISM; HUMANS; NALTREXONE; NARCOTIC ANTAGONISTS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; TREATMENT OUTCOME;

EID: 84953737113     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1001924     Document Type: Article

References (46)

1. Rehm J, Mathers C, Popova S, Thavorncharoensap M, Teerawattananon Y, Patra J, Global burden of disease and injury and economic cost attributable to alcohol use and alcohol-use disorders. Lancet. 2009;373:2223–2233. doi: 10.1016/S0140-6736(09)60746-7 19560604
2. McCambridge J, Kypri K, Drummond C, Strang J, Alcohol harm reduction: corporate capture of a key concept. PLoS Med. 2014;11:e1001767. doi: 10.1371/journal.pmed.1001767 25490717
3. Marlatt GA, Witkiewitz K, Harm reduction approaches to alcohol use: health promotion, prevention, and treatment. Addict Behav. 2002;27:867–886. 12369473
4. European Medicines Agency. Assessment report: Selincro—international non-proprietory name: nalmefene. EMA/78844/2013. 13 Dec 2012. Available: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002583/WC500140326.pdf. Accessed 16 November 2015.
5. National Institute for Health and Care ExcellenceNalmefene for reducing alcohol consumption in people with alcohol dependence: evaluation report. London: National Institute for Health and Care Excellence; 2014.
6. Stevenson M, Pandor A, Stevens JW, Rawdin A, Rice P, Thompson J, et al. Nalmefene for reducing alcohol consumption in people with alcohol dependence: an evidence review group perspective of a NICE single technology appraisal. Pharmacoeconomics. 2015;33:833–847. doi: 10.1007/s40273-015-0272-0 25851485
7. Haute Autorité de Santé Commission de la TransparenceSelincro 18 mg, comprimés pelliculés. Saint-Denis: Haute Autorité de Santé; 2013. Available: http://www.has-sante.fr/portail/upload/docs/evamed/CT-12915_SELINCRO_PIC_INS_Avis3_CT12915.pdf. Accessed 16 November 2015.
8. Stafford N, German evaluation says new drug for alcohol dependence is no better than old one. BMJ. 2014;349:g7544. doi: 10.1136/bmj.g7544 25487784
9. Tandvårds-och Läkemedelsförmånsverket. Selincro ingår inte i högkostnadsskyddet. 3 Mar 2015. Available: http://www.tlv.se/beslut/beslut-lakemedel/avslag-uteslutningar/Selincro-ingar-inte-i-hogkostnadsskyddet. Accessed 16 November 2015.
10. Paille F, Martini H, Nalmefene: a new approach to the treatment of alcohol dependence. Subst Abuse Rehabil. 2014;5:87–94. doi: 10.2147/SAR.S45666 25187751
11. Luquiens A, Aubin HJ, Patient preferences and perspectives regarding reducing alcohol consumption: role of nalmefene. Patient Prefer Adherence. 2014;8:1347–1352. doi: 10.2147/PPA.S57358 25302021
12. Spence D, Bad medicine: nalmefene in alcohol misuse. BMJ. 2014;348:g1531. doi: 10.1136/bmj.g1531 24531208
13. Braillon A, Nalmefene in alcohol misuse: junk evaluation by the European Medicines Agency. BMJ. 2014;348:g2017. doi: 10.1136/bmj.g2017 24614566
14. Jonas DE, Amick HR, Feltner C, Bobashev G, Thomas K, Wines R, et al. Pharmacotherapy for adults with alcohol use disorders in outpatient settings: a systematic review and meta-analysis. JAMA. 2014;311:1889–1900. doi: 10.1001/jama.2014.3628 24825644
15. Higgins JPT, Green S, Cochrane handbook for systematic reviews of interventions. Cochrane Collaboration. Version 5.1.0. Available: http://www.cochrane-handbook.org/. Accessed 25 November 2015.
16. Sterne JA, Sutton AJ, Ioannidis JP, Terrin N, Jones DR, Lau J, et al. Recommendations for examining and interpreting funnel plot asymmetry in meta-analyses of randomised controlled trials. BMJ. 2011;343:d4002. doi: 10.1136/bmj.d4002 21784880
17. R Development Core TeamR: a language and environment for statistical computing. Vienna: R Foundation for Statistical Computing Vienna; 2009.
18. Schwarzer G. meta: general package for meta-analysis, version 3.6–0. 27 May 2014. Available: https://cran.r-project.org/src/contrib/Archive/meta/. Accessed 18 November 2015.
19. Lumley T. rmeta: meta-analysis, version 2.16. 29 October 2012. Available: https://cran.r-project.org/web/packages/rmeta/index.html. Accessed 18 November 2015.
20. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Med. 2009;6:e1000100. doi: 10.1371/journal.pmed.1000100 19621070
21. Guang Y, Pixu S, Minge X. gmeta: a unified meta-analysis approach based on confidence distribution. R package version 2.2–3. 2013.
22. Chen DG, Peace KE, Applied meta-analysis with R. Boca Raton (Florida): CRC Press; 2013.
23. Rücker G, Schwarzer G, Krahn U, König J. netmeta: network meta-analysis using frequentist methods, version 0.8–0. 26 June 2015. Available: https://cran.r-project.org/web/packages/netmeta/index.html. Accessed 18 November 2015.
24. Gual A, He Y, Torup L, van den Brink W, Mann K, A randomised, double-blind, placebo-controlled, efficacy study of nalmefene, as-needed use, in patients with alcohol dependence. Eur Neuropsychopharmacol. 2013;23:1432–1442. doi: 10.1016/j.euroneuro.2013.02.006 23562264
25. Mann K, Bladstrom A, Torup L, Gual A, van den Brink W, Extending the treatment options in alcohol dependence: a randomized controlled study of as-needed nalmefene. Biol Psychiatry. 2013;73:706–713. doi: 10.1016/j.biopsych.2012.10.020 23237314
26. Karhuvaara S, Simojoki K, Virta A, Rosberg M, Löyttyniemi E, Nurminen T, et al. Targeted nalmefene with simple medical management in the treatment of heavy drinkers: a randomized double-blind placebo-controlled multicenter study. Alcohol Clin Exp Res. 2007;31:1179–1187. doi: 10.1111/j.1530-0277.2007.00401.x 17451401
27. van den Brink W, Sorensen P, Torup L, Mann K, Gual A, Long-term efficacy, tolerability and safety of nalmefene as-needed in patients with alcohol dependence: a 1-year, randomised controlled study. J Psychopharmacol. 2014;28:733–744. doi: 10.1177/0269881114527362 24671340
28. Mason BJ, Ritvo EC, Morgan RO, Salvato FR, Goldberg G, Welch B, et al. A double-blind, placebo-controlled pilot study to evaluate the efficacy and safety of oral nalmefene HCl for alcohol dependence. Alcohol Clin Exp Res. 1994;18:1162–1167. 7847600
29. Mason BJ, Salvato FR, Williams LD, Ritvo EC, Cutler RB, A double-blind, placebo-controlled study of oral nalmefene for alcohol dependence. Arch Gen Psychiatry. 1999;56:719–724. 10435606
30. Anton RF, Pettinati H, Zweben A, Kranzler HR, Johnson B, Bohn MJ, et al. A multi-site dose ranging study of nalmefene in the treatment of alcohol dependence. J Clin Psychopharmacol. 2004;24:421–428. 15232334
31. Becker SJ, Curry JF, Yang C, Longitudinal association between frequency of substance use and quality of life among adolescents receiving a brief outpatient intervention. Psychol Addict Behav. 2009;23:482–490. doi: 10.1037/a0016579 19769432
32. Muckle W, Muckle J, Welch V, Tugwell P, Managed alcohol as a harm reduction intervention for alcohol addiction in populations at high risk for substance abuse. Cochrane Database Syst Rev. 2012;12:CD006747. doi: 10.1002/14651858.CD006747.pub2 23235633
33. Laramee P, Brodtkorb TH, Rahhali N, Knight C, Barbosa C, Francois C, et al. The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels: a Markov model. BMJ Open. 2014;4:e005376. doi: 10.1136/bmjopen-2014-005376 25227627
34. Roerecke M, Sorensen P, Laramee P, Rahhali N, Rehm J, Clinical relevance of nalmefene versus placebo in alcohol treatment: reduction in mortality risk. J Psychopharmacol. 2015;29:1152–1158. doi: 10.1177/0269881115602487 26349557
35. van den Brink W, Aubin HJ, Bladstrom A, Torup L, Gual A, Mann K, Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies. Alcohol Alcohol. 2013;48:570–578. doi: 10.1093/alcalc/agt061 23873853
36. Sun X, Briel M, Busse JW, You JJ, Akl EA, Mejza F, et al. Credibility of claims of subgroup effects in randomised controlled trials: systematic review. BMJ. 2012;344:e1553. doi: 10.1136/bmj.e1553 22422832
37. Pettinati HM, Silverman BL, Battisti JJ, Forman R, Schweizer E, Gastfriend DR, Efficacy of extended-release naltrexone in patients with relatively higher severity of alcohol dependence. Alcohol Clin Exp Res. 2011;35:1804–1811. doi: 10.1111/j.1530-0277.2011.01524.x 21575016
38. National Institute for Health and Care Excellence. Alcohol-use disorders: diagnosis, assessment and management of harmful drinking and alcohol dependence. NICE guidelines CG115. London: National Institute for Health and Care Excellence; 2011.
39. Sleight P, Debate: subgroup analyses in clinical trials: fun to look at—but don’t believe them! Curr Control Trials Cardiovasc Med. 2000;1:25–27. doi: 10.1186/cvm-1-1-025 11714402
40. Sun X, Ioannidis JP, Agoritsas T, Alba AC, Guyatt G, How to use a subgroup analysis: users’ guide to the medical literature. JAMA. 2014;311:405–411. doi: 10.1001/jama.2013.285063 24449319
41. Swift RM, Naltrexone and nalmefene: any meaningful difference? Biol Psychiatry. 2013;73:700–701. doi: 10.1016/j.biopsych.2013.03.002 23540350
42. Donoghue K, Elzerbi C, Saunders R, Whittington C, Pilling S, Drummond C, The efficacy of acamprosate and naltrexone in the treatment of alcohol dependence, Europe versus the rest of the world: a meta-analysis. Addiction. 2015;110:920–930. doi: 10.1111/add.12875 25664494
43. Dumville JC, Torgerson DJ, Hewitt CE, Reporting attrition in randomised controlled trials. BMJ. 2006;332:969–971. doi: 10.1136/bmj.332.7547.969 16627519
44. Leon AC, Mallinckrodt CH, Chuang-Stein C, Archibald DG, Archer GE, Chartier K, Attrition in randomized controlled clinical trials: methodological issues in psychopharmacology. Biol Psychiatry. 2006;59:1001–1005. doi: 10.1016/j.biopsych.2005.10.020 16503329
45. Witkiewitz K, Falk DE, Kranzler HR, Litten RZ, Hallgren KA, O’Malley SS, et al. Methods to analyze treatment effects in the presence of missing data for a continuous heavy drinking outcome measure when participants drop out from treatment in alcohol clinical trials. Alcohol Clin Exp Res. 2014;38:2826–2834. doi: 10.1111/acer.12543 25421518
46. Gregoire G, Derderian F, Le Lorier J, Selecting the language of the publications included in a meta-analysis: is there a Tower of Babel bias? J Clin Epidemiol. 1995;48:159–163. 7853041