Marco Di Nicola1, Sergio De Filippis2,3, Giovanni Martinotti4, Luisa De Risio5, Mauro Pettorruso5, Simone De Persis2, Angelo Giovanni Icro Maremmani6, Icro Maremmani6, Massimo di Giannantonio4, Luigi Janiri5. 1. Institute of Psychiatry and Psychology, Fondazione Policlinico Universitario "A. Gemelli", Università Cattolica del Sacro Cuore, Rome, Italy. marcodinicola.md@gmail.com. 2. Psychiatric Clinic "Von Siebenthal", Rome, Italy. 3. Department of Medical Sciences, School of Medicine and Psychology, Sapienza University, Rome, Italy. 4. Department of Neuroscience and Imaging, Institute of Psychiatry, "G. d'Annunzio" University of Chieti-Pescara, Chieti, Italy. 5. Institute of Psychiatry and Psychology, Fondazione Policlinico Universitario "A. Gemelli", Università Cattolica del Sacro Cuore, Rome, Italy. 6. "Vincent P. Dole" Dual Diagnosis Unit, Santa Chiara University Hospital, University of Pisa, Pisa, Italy.
Abstract
INTRODUCTION: Nalmefene is the first drug to be approved for reducing alcohol consumption in alcohol use disorder (AUD) patients at high drinking risk. In real-world settings, there is a high prevalence of concurrent psychiatric disorders in AUD subjects, with associated increased morbidity and worse prognosis. This study evaluated the use of nalmefene in AUD patients with stabilized psychiatric comorbidity previously treated unsuccessfully for alcohol dependence, and assessed craving reduction and safety. METHODS: Sixty-five AUD outpatients treated with as-needed 18 mg nalmefene for 24 weeks were included. Primary outcome measures were: changes in heavy drinking days (HDDs) and total alcohol consumption (TAC, g/day). Secondary outcome measures were: changes in drinking risk level and craving (obsessive-compulsive drinking scale and visual analogue scale for craving). RESULTS: Forty-two AUD subjects (64.6%) had one or more stabilized psychiatric comorbidity. There was a significant reduction in HDDs, TAC and craving measures (p < 0.001), with no differences between subjects with and without psychiatric comorbidity. Nalmefene was safe and well tolerated in all patients. CONCLUSION: As-needed nalmefene reduced drinking and craving in AUD subjects with and without psychiatric comorbidity. These findings suggest that nalmefene is a valid therapeutic option in real-world clinical settings, where comorbid conditions are common, and has the potential to engage AUD patients who may otherwise not have sought help. FUNDING: Lundbeck Italia S.P.A.
INTRODUCTION:Nalmefene is the first drug to be approved for reducing alcohol consumption in alcohol use disorder (AUD) patients at high drinking risk. In real-world settings, there is a high prevalence of concurrent psychiatric disorders in AUD subjects, with associated increased morbidity and worse prognosis. This study evaluated the use of nalmefene in AUD patients with stabilized psychiatric comorbidity previously treated unsuccessfully for alcohol dependence, and assessed craving reduction and safety. METHODS: Sixty-five AUD outpatients treated with as-needed 18 mg nalmefene for 24 weeks were included. Primary outcome measures were: changes in heavy drinking days (HDDs) and total alcohol consumption (TAC, g/day). Secondary outcome measures were: changes in drinking risk level and craving (obsessive-compulsive drinking scale and visual analogue scale for craving). RESULTS: Forty-two AUD subjects (64.6%) had one or more stabilized psychiatric comorbidity. There was a significant reduction in HDDs, TAC and craving measures (p < 0.001), with no differences between subjects with and without psychiatric comorbidity. Nalmefene was safe and well tolerated in all patients. CONCLUSION: As-needed nalmefene reduced drinking and craving in AUD subjects with and without psychiatric comorbidity. These findings suggest that nalmefene is a valid therapeutic option in real-world clinical settings, where comorbid conditions are common, and has the potential to engage AUD patients who may otherwise not have sought help. FUNDING: Lundbeck Italia S.P.A.
Entities:
Keywords:
Alcohol use disorder; Comorbidity; Craving; Nalmefene; Psychiatry; Reduced-risk drinking