title: The Effects of as-Needed Nalmefene on Patient-Reported Outcomes and Quality of Life in Relation to a Reduction in Alcohol Consumption in Alcohol-Dependent Patients.
abstract: BACKGROUND
  The objective of this article was to investigate the effect of as-needed nalmefene on health-related quality of life (HRQoL) in patients with alcohol dependence, and to relate changes in drinking behavior and status to HRQoL outcomes.
  
  
  METHODS
  This post hoc analysis was conducted on a pooled subgroup of patients with at least a high drinking risk level (men: >60 g/day; women: >40 g/day) who participated in one of two randomized controlled 6-month studies, ESENSE 1 and ESENSE 2. Patients received nalmefene 18 mg or placebo on an as-needed basis, in addition to a motivational and adherence-enhancing intervention (BRENDA). At baseline and after 12 and 24 weeks questionnaires for the Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36), European Quality of life-5 Dimensions (EQ-5D) and the Drinker Inventory of Consequences (DrInC-2R) were completed.
  
  
  RESULTS
  The pooled population consisted of 667 patients (nalmefene: 335; placebo: 332), with no notable between-group differences in baseline patient demographics/characteristics. At week 24, nalmefene had a superior effect compared to placebo in improving SF-36 mental component summary scores (mean difference [95% CI], p-value: 3.09 [1.29, 4.89]; p=0.0008), SF-36 physical component summary scores (1.23 [0.15, 2.31]; p=0.026), EQ-5D utility index scores (0.03 [0.00, 0.06]; p=0.045), EQ-5D health state scores (3.46 [0.75, 6.17]; p=0.012), and DrInC-2R scores (-3.22 [-6.12, 0.33]; p=0.029). The improvements in SF-36 mental component summary scores at week 24, and the DrInC-2R total score change from baseline to week 24, were significantly correlated to reductions in heavy drinking days and total alcohol consumption at week 24.
  
  
  CONCLUSIONS
  As-needed nalmefene significantly improved almost all patient-reported HRQoL measures included in SF-36 and EQ-5D compared with placebo. These HRQoL gains were significantly correlated to reduced drinking behavior, as determined by reductions in heavy drinking days and total alcohol consumption.
authors.affiliation: H. Lundbeck A/S, Issy les Moulineaux Cedex, France.
authors.forename: Clément
authors.initials: C
authors.lastname: François
authors.affiliation: H. Lundbeck A/S, Issy les Moulineaux Cedex, France.
authors.forename: Nora
authors.initials: N
authors.lastname: Rahhali
authors.affiliation: H. Lundbeck A/S, Issy les Moulineaux Cedex, France.
authors.forename: Ylana
authors.initials: Y
authors.lastname: Chalem
authors.affiliation: H. Lundbeck A/S, 2500 Valby, Denmark.
authors.forename: Per
authors.initials: P
authors.lastname: Sørensen
authors.affiliation: Assistance Publique-Hôpitaux de Paris, Hôpital Paul Brousse, INSERM U669, Villejuif Cedex, France.
authors.forename: Amandine
authors.initials: A
authors.lastname: Luquiens
authors.affiliation: Assistance Publique-Hôpitaux de Paris, Hôpital Paul Brousse, INSERM U669, Villejuif Cedex, France.
authors.forename: Henri-Jean
authors.initials: HJ
authors.lastname: Aubin
mesh_terms: D000328:Adult; D000428:Alcohol Drinking / Q000188:drug therapy*; D000437:Alcoholism / Q000188:drug therapy*; D003710:Demography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D063868:Patient Outcome Assessment; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D009271:Naltrexone; C038981:nalmefene