Clinical relevance of nalmefene versus placebo in alcohol treatment: reduction in mortality risk.
Reduction of long-term mortality risk, an important clinical outcome for people in alcohol dependence treatment, can rarely be established in randomized controlled trials (RCTs). We calculated the reduction in all-cause mortality risk using data from short-term (6 and 12 months) double-blind RCTs comparing as-needed nalmefene treatment to placebo, and mortality risks from meta-analyses on all-cause-mortality risk by reduction of drinking in people with alcohol dependence. A reduction in drinking in the RCTs was defined by shifts in drinking risk levels established by the European Medicines Agency. Results showed that the reduction of drinking in the nalmefene group was associated with a reduction in mortality risk by 8% (95% CI: 2%, 13%) when compared to the placebo group. Sensitivity analyses confirmed a significant effect. Thus comparing the difference between nalmefene and placebo in reduction in drinking levels with results on all-cause mortality risk from meta-analyses indicated a clinically relevant reduction in mortality risk. Given the high mortality risk of people with alcohol dependence, abstinence or a reduction in drinking have been shown to reduce mortality risk and should be considered treatment goals.
Social and Epidemiological Research Department, Centre for Addiction and Mental Health (CAMH), Toronto, ON, Canada Dalla Lana School of Public Health (DLSPH), University of Toronto, Toronto, ON, Canada michael.roerecke@camh.ca.
Michael
M
Roerecke
H. Lundbeck A/S, Valby, Denmark.
Per
P
Sørensen
Lundbeck SAS, Issy-les-Moulineaux, France Université Claude Bernard Lyon I, Villeurbanne, France.
Philippe
P
Laramée
Lundbeck SAS, Issy-les-Moulineaux, France.
Nora
N
Rahhali
Social and Epidemiological Research Department, Centre for Addiction and Mental Health (CAMH), Toronto, ON, Canada Dalla Lana School of Public Health (DLSPH), University of Toronto, Toronto, ON, Canada Institute of Medical Science, University of Toronto, Toronto, ON, Canada Department of Psychiatry, University of Toronto, Toronto, ON, Canada.
Jürgen
J
Rehm
D000437:Alcoholism / Q000188:drug therapy* / Q000401:mortality*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009271:Naltrexone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D009292:Narcotic Antagonists / Q000627:therapeutic use; D010919:Placebos; D016032:Randomized Controlled Trials as Topic
D009292:Narcotic Antagonists; D010919:Placebos; D009271:Naltrexone; C038981:nalmefene
Alcohol dependence; alcohol treatment; clinical relevance; meta-analysis; mortality; nalmefene; placebo