Abstract
BackgroundThe 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.MethodsThis 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.ResultsThe 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.ConclusionsAs-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.
Highlights
Alcohol dependence has been estimated to affect 8 million persons in the USA [1] and 14.6 million in Europe [2] and, as such, is a major public health concern
At week 24, nalmefene had a superior effect compared to placebo in improving SF-36 mental component summary scores, SF-36 physical component summary scores (1.23 [0.15, 2.31]; p=0.026), EQ5D utility index scores (0.03 [0.00, 0.06]; p=0.045), European Quality of life-5 Dimensions (EQ-5D) health state scores (3.46 [0.75, 6.17]; p=0.012), and Drinker Inventory of Consequences (DrInC)-2R scores (-3.22 [-6.12, 0.33]; p=0.029)
As-needed nalmefene significantly improved almost all patient-reported healthrelated quality of life (HRQoL) measures included in SF-36 and EQ-5D compared with placebo
Summary
Alcohol dependence has been estimated to affect 8 million persons in the USA [1] and 14.6 million in Europe [2] and, as such, is a major public health concern. In 2004, 3.8% of all global deaths (6.3% for men and 1.1% for women) and 4.6% of disease burden and injury (7.6% for men and 1.4% for women) were attributed to alcohol [6]. These rates are similar to those associated with the use of tobacco [6]. The objective of this article was to investigate the effect of as-needed nalmefene on healthrelated quality of life (HRQoL) in patients with alcohol dependence, and to relate changes in drinking behavior and status to HRQoL outcomes
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