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.
CONCLUSIONS: Acamprosate was ineffective in reducing drinking in this Korean sample. The result differs from that of most European acamprosate trials. This might be explained by our sample's relatively severe alcohol dependence, and low social support, or the fact that many patients were still drinking near to their first medication. The variability of the psychosocial support, ethnicity (which might also affect acamprosate pharmacokinetics) and the Korean drinking style, which differs from that of Europeans, might have contributed to our negative result.

RCT Entities:   Population Interventions Outcomes