[Naltrexone in the treatment of alcoholism. Clinical evolution, safety and efficacy in a sample of 198 patients].

BACKGROUND

Our aim was to verify the safety of naltrexone administered during 6 months to alcohol-dependent patients submitted to detoxification. In addition, we aimed at contributing new data on the course of craving and alcohol consumption in naltrexone treated patients and to study prognostic factors predictive of response to treatment.

METHODS

Multicenter, prospective, pharmacovigilance, follow-up study of a cohort of 198 patients older than 18 years of age meeting DSM-IV criteria for alcohol dependence, who were administered naltrexone over a 6 months period.

RESULTS

77 patients (39.1%) had some adverse event (AA) during the study, including nausea/vomiting (13.7%), sleepiness/sedation (12.8%) and asthenia-laxity-fatigability (10.3%). Only 3.6% of AA were considered severe (6 cases). As to laboratory values, no relevant hematological abnormalities were observed, yet significant reductions from baseline were recorded for cholesterol, total and conjugated bilirubin, transaminases (AST/ALT), and *-GT. Overall, patients had a notable improvement, as reflected by a decrease in craving (from 22.5 to 5.3 on the OCDS scale; p < 0.01), as well as an improved in both global activity (from 68.7 to 85.4 on the EEAG; p < 0.01) and depressive symptoms (from 12.0 to 4.1 on the MDRS scale; p < 0.01). Time passed until first relapse was 33 days, and the abstinence cumulative duration was 126 days. No predictive model of therapeutic success with sufficient statistical power was obtained to guarantee its use in clinical practice.

CONCLUSIONS

Naltrexona has a good safety profile to treat alcoholic patients. No predictive factors of response to treatment was found. Thus, the question about which alcoholic patients could mostly benefit from naltrexone treatment remains unanswered.