TY - JOUR
T1 - A randomised, double-blind, placebo-controlled, efficacy study of nalmefene, as-needed use, in patients with alcohol dependence
AU - Gual, Antoni
AU - He, Yuan
AU - Torup, Lars
AU - van den Brink, Wim
AU - Mann, Karl
AU - AUTHOR GROUP
AU - Domken, Marc-André
AU - Geerts, Stefaan
AU - Matthys, Frieda
AU - Peuskens, Hendrik
AU - de Nayer, André
AU - van den Ameele, Hans
AU - Gazziano, Antonio
AU - Drahozal, Jan
AU - Solle, Zdenek
AU - Syrovatka, Jiri
AU - Loiseau, Thierry
AU - Herve, Jean-Paul
AU - Reynaud, Michel
AU - Louvrier, Jacques
AU - Khalifa, Paule
AU - Modavi, David
AU - Grabli, Frédéric
AU - Fontbonne, Dominique Penneau
AU - Batel, Philippe
AU - Mhiri, Radhouan
AU - Gailledreau, Joel
AU - Paille, François
AU - Perney, Pascal
AU - Peyron, Eric
AU - Dally, Sylvain
AU - Bendimerad, Patrick
AU - Aubin, Henri-Jean
AU - Ceccanti, Mauro
AU - Fertonani-Affini, Giuseppe
AU - Addolorato, Giovanni
AU - Patussi, Valentino
AU - Lancia, Ugo
AU - Zoli, Giorgio
AU - Janiri, Luigi
AU - del Re, Arfedele
AU - Serretti, Alessandro
AU - Montesano, Franco
AU - Samochowiec, Jerzy
AU - Koston-Medrala, Dominika
AU - Bogacki, Przemyslaw
AU - Perucki, Mariusz
AU - Badzio-Jagiello, Hanna
AU - Malicki, Dariusz
AU - Domanski, Marek
AU - Ismail, Fátima Akbarali
PY - 2013
Y1 - 2013
N2 - This study evaluated the efficacy of as-needed use of the opioid system modulator nalmefene in reducing alcohol consumption in patients with alcohol dependence. Seven hundred and eighteen patients (placebo=360; nalmefene=358), ≥ 18 years of age, with a diagnosis of alcohol dependence, ≥ 6 heavy drinking days and an average alcohol consumption ≥ WHO medium drinking risk level in the 4 weeks preceding screening, were randomised (1:1) to 24 weeks of as-needed placebo or nalmefene 18 mg/day. The co- primary efficacy analyses showed a significantly superior effect of nalmefene compared to placebo in the change from baseline to month 6 in heavy drinking days (group difference: -1.7 days/month [95% CI -3.1; -0.4]; p=0.012) and a better but not significant effect in reducing total alcohol consumption (group difference: -5.0 g/day last month [95% CI -10.6; 0.7]; p=0.088). A subgroup analysis showed that patients who did not reduce their drinking prior to randomisation benefitted more from nalmefene. Improvements in Clinical Global Impression and reductions in liver enzymes were greater in the nalmefene group than in the placebo group. Adverse events were more common with nalmefene; the incidence of adverse events leading to dropout was similar in both groups. This study provides evidence for the efficacy of nalmefene, which constitutes a new pharmacological treatment paradigm in terms of treatment goal (reduced drinking) and dosing regimen (as-needed), in alcohol dependent patients unable to reduce alcohol consumption on their own
AB - This study evaluated the efficacy of as-needed use of the opioid system modulator nalmefene in reducing alcohol consumption in patients with alcohol dependence. Seven hundred and eighteen patients (placebo=360; nalmefene=358), ≥ 18 years of age, with a diagnosis of alcohol dependence, ≥ 6 heavy drinking days and an average alcohol consumption ≥ WHO medium drinking risk level in the 4 weeks preceding screening, were randomised (1:1) to 24 weeks of as-needed placebo or nalmefene 18 mg/day. The co- primary efficacy analyses showed a significantly superior effect of nalmefene compared to placebo in the change from baseline to month 6 in heavy drinking days (group difference: -1.7 days/month [95% CI -3.1; -0.4]; p=0.012) and a better but not significant effect in reducing total alcohol consumption (group difference: -5.0 g/day last month [95% CI -10.6; 0.7]; p=0.088). A subgroup analysis showed that patients who did not reduce their drinking prior to randomisation benefitted more from nalmefene. Improvements in Clinical Global Impression and reductions in liver enzymes were greater in the nalmefene group than in the placebo group. Adverse events were more common with nalmefene; the incidence of adverse events leading to dropout was similar in both groups. This study provides evidence for the efficacy of nalmefene, which constitutes a new pharmacological treatment paradigm in terms of treatment goal (reduced drinking) and dosing regimen (as-needed), in alcohol dependent patients unable to reduce alcohol consumption on their own
U2 - https://doi.org/10.1016/j.euroneuro.2013.02.006
DO - https://doi.org/10.1016/j.euroneuro.2013.02.006
M3 - Article
C2 - 23562264
SN - 0924-977X
VL - 23
SP - 1432
EP - 1442
JO - European neuropsychopharmacology
JF - European neuropsychopharmacology
IS - 11
ER -