ACAMPROSATE IN KOREAN ALCOHOL-DEPENDENT PATIENTS: A MULTI-CENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

— Aims:A multi-centre, randomized, double-blind, placebo-controlled trial was conducted to evaluate the efficacy and the safety of acamprosate over 8 weeks in Korean alcohol-dependent patients. Methods: One hundred and forty-two alcohol-dependent patients in 12 centres were randomized to 8 weeks treatment with either acamprosate (n = 72) or a placebo (n = 70) in combination with out-patient psychosocial intervention. They were predominantly male (95.8%), with a mean age of 44.3 ± 8.3 years; 76.1% were married; 59.9% were employed; 58.5% had received previous alcoholism treatment (previous mean number of admissions in alcoholism in-patient programmes 4.6 ± 6.9). At visits to the clinic (weekly for 4 weeks, then biweekly for 4 weeks), a record was made of alcohol use (Time-Line Follow-Back), alcohol craving using a Korean version of the Obsessive Compulsive Drinking Scale and a visual analogue scale, and adverse events. Serum aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase (GGT), blood urea nitrogen and creatinine levels were measured on weeks 0, 2, 4 and 8. Results: In the acamprosate group (A), 71.4% had had alcohol within the 2 days prior to starting medication, against 65.2% of patients in the placebo group (P); (P > 0.05). One hundred and one subjects (71.1%) completed 8-weeks of treatment (A, 73.6%; P, 68.6%; P > 0.05). During the 8-week treatment period, 37, (A) (n = 72) and 32% (P) (n = 70) achieved continuous abstinence (P > 0.05), and 40, (A) and 39% (P) remained without relapse (P > 0.05) (defined as a day when a man consumed five or more drinks or a woman four or more drinks). The percentage of days abstinent during the 8-week treatment period was 81.2, (A) and 78.5% (P) (P > 0.05), and the percentage of days without heavy drinking 86.1 (A) and 84.9% (P) (P > 0.05). The mean amount drunk per drinking occasion was 7.2, (A) and 8.6 standard drinks (P) (P > 0.05). No statistically significant differences in changes in the serum GGT level or craving scores from baseline to the end-point of treatment were found between the two groups. Recency of drinking prior to commencing study drug predicted percentage of days abstinent in the first 2 weeks on treatment; however, when ANOVAs were conducted using treatment outcomes as a dependent variable, medication condition as an independent variable and the period of abstinence prior to treatment as a covariate, a significant effect of medication condition was still not seen. Conc