Nalmefene, Given as Needed, in the Routine Treatment of Patients with Alcohol Dependence: An Interventional, Open-Label Study in Primary Care
| Autor: | Didier Meulien, Maiken Brix Schou, Josef Großkopf, Doris Zhang, Björn Steiniger Brach, Edmund Stewart, Carlos Brotons, Philippe Castera |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Health (social science) Nausea Medicine (miscellaneous) Alcohol 03 medical and health sciences chemistry.chemical_compound Young Adult 0302 clinical medicine Internal medicine medicine Humans 030212 general & internal medicine Adverse effect Nalmefene Primary Health Care business.industry Alcohol dependence Middle Aged Combined Modality Therapy Naltrexone Clinical trial Psychotherapy Psychiatry and Mental health Alcoholism Neuroprotective Agents Treatment Outcome chemistry Cohort Female medicine.symptom business Psychosocial 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | European addiction research. 24(6) |
| ISSN: | 1421-9891 |
| Popis: | Aims: This 12-week, open-label, primary care study (NCT02195817) evaluated the efficacy and safety of nalmefene, taken as needed, to reduce alcohol consumption in adults with a diagnosis of alcohol dependence and drinking at least at high drinking risk levels (DRL, > 60 g/day for men, > 40 g/day for women). Methods: Following the Screening Visit, patients recorded their daily alcohol consumption for 2 weeks. Patients were then categorised by their self-reported drinking levels; those who maintained at least a high DRL in the 2-week period were included in Cohort-A, and those who reduced their alcohol consumption below high DRL were included in Cohort-B. Cohort-A received simple psychosocial interventions and were supplied with nalmefene 18 mg to be taken on days when they perceived a risk of drinking alcohol. Patients in Cohort-B received a simple psychosocial intervention and were treated per normal practice. Results: Of the 378 enrolled patients, 330 were included in Cohort-A and 48 in Cohort-B. For patients in Cohort-A, the mean change from screening to Week-12 in the number of heavy drinking days/month was –13.1 days/month (95% CI –14.4 to –11.9, p < 0.0001). Overall, 55% of patients reduced their DRL by ≥2 risk levels and 44% of patients reduced to a low DRL. The most common adverse events were nausea (18.3%) and dizziness (17.7%). Patients in Cohort-B maintained their lower level alcohol consumption at the 12-week follow-up. Conclusions: Patients with alcohol dependence treated in primary care with nalmefene, taken as needed, in conjunction with simple psychosocial support, significantly reduced their alcohol consumption. Treatment was well tolerated. |
| Databáze: | OpenAIRE |
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