A Trial-Based Predictive Microsimulation Assessing the Public Health Benefits of Nalmefene and Psychosocial Support for the Reduction of Alcohol Consumption in Alcohol Dependence.
BACKGROUND
Alcohol dependence causes considerable harm to patients. Treatment with nalmefene, aiming to reduce consumption rather than maintain complete abstinence, has been licensed based on trials demonstrating a reduction in total alcohol consumption and heavy drinking days. Relating these trial outcomes to harmful events avoided is important to demonstrate the clinical relevance of nalmefene treatment.


METHODS
A predictive microsimulation model was developed to compare nalmefene plus brief psychosocial intervention (BRENDA) versus placebo plus BRENDA for the treatment of patients with alcohol dependence and a high or very high drinking risk level based on three pooled clinical trials. The model simulated patterns and level of alcohol consumption, day-by-day, for 12 months, to estimate the occurrence of alcohol-attributable diseases, injuries and deaths; assessing the clinical relevance of reducing alcohol consumption with treatment.


RESULTS
The microsimulation model predicted that, in a cohort of 100,000 patients, 971 (95 % confidence interval [CI] 904-1038) alcohol-attributable diseases and injuries and 133 (95 % CI 117-150) deaths would be avoided with nalmefene versus placebo. This level of benefit has been considered clinically relevant by the European Medicines Agency.


CONCLUSIONS
This microsimulation model supports the clinical relevance of the reduction in alcohol consumption, and has estimated the extent of the public health benefit of treatment with nalmefene in patients with alcohol dependence and a high or very high drinking risk level.
Social and Epidemiological Research Department, Centre for Addiction and Mental Health, Toronto, M5S 2S1, Canada. plaramee@outlook.com.
Philippe
P
Laramée
Health Economics and Outcomes Research, Creativ-Ceutical, 75008, Paris, France.
Aurélie
A
Millier
Global Analytics, Lundbeck SAS, 92445, Issy-les-Moulineaux Cedex, France.
Nora
N
Rahhali
Health Economics and Outcomes Research, Creativ-Ceutical, 75008, Paris, France.
Olivier
O
Cristeau
Health Economics and Outcomes Research, Creativ-Ceutical, 75008, Paris, France.
Samuel
S
Aballéa
Global Outcomes Research, Lundbeck SAS, 92445, Issy-les-Moulineaux Cedex, France.
Clément
C
François
Global Outcomes Research, Lundbeck SAS, 92445, Issy-les-Moulineaux Cedex, France.
Ylana
Y
Chalem
Laboratoire de Santé Publique, Faculté de Médecine, Université de la Méditerranée, 13385, Marseille, France.
Mondher
M
Toumi
Social and Epidemiological Research Department, Centre for Addiction and Mental Health, Toronto, M5S 2S1, Canada.|Dalla Lana School of Public Health, University of Toronto, Toronto, M5T 3M7, Canada.|Klinische Psychologie und Psychotherapie, TU Dresden, 01187, Dresden, Germany.
Jürgen
J
Rehm
D000428:Alcohol Drinking / Q000009:adverse effects / Q000188:drug therapy* / Q000523:psychology; D000437:Alcoholism / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D003198:Computer Simulation; D005060:Europe; D040261:Harm Reduction / Q000187:drug effects; D006801:Humans; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D009271:Naltrexone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D009292:Narcotic Antagonists / Q000627:therapeutic use; D010043:Outcome and Process Assessment, Health Care / Q000706:statistics & numerical data; D011634:Public Health / Q000379:methods* / Q000706:statistics & numerical data; D012944:Social Support
D009292:Narcotic Antagonists; D009271:Naltrexone; C038981:nalmefene