Topiramate reduces the harm of excessive drinking: implications for public health and primary care.

AIMS: Having demonstrated previously the efficacy of topiramate--a sulfamate-substituted fructopyranose derivative-as pharmacotherapy for treating alcohol dependence, promoting abstinence and reducing the harmful psychosocial consequences of drinking, we investigated whether topiramate also promoted 'safe' levels of drinking: < or = 1 and < or = 2 standard drinks/day for women and men, respectively, among alcohol-dependent individuals. DESIGN, SETTING AND PARTICIPANTS: In a double-blind, randomized, controlled, 12-week clinical trial conducted in San Antonio, Texas, 75 alcohol-dependent adults received topiramate and 75 received placebo as an adjunct to weekly standardized medication compliance management. MEASUREMENTS: For this secondary analysis of data from that trial, we calculated, based on self-reports, specific intervals of up to 30 days of continuous 'safe' drinking for each subject.
FINDINGS: The average longest 'safe' drinking period was 16.7 days for topiramate recipients versus 8.9 days for placebo recipients. By day 50 of treatment, 44% versus 26.4% had achieved > or = 7 and 30.8% versus 10% had achieved > or = 14 continuous 'safe' drinking days. Similarly, topiramate increased the relative likelihood of continuous 'safe' drinking from 77% for > or = 7 days [relative risk (RR) for achieving continuous 'safe' drinking = 1.77] to threefold for > or = 14 days (RR = 3.37) and fourfold for > or = 28 days (RR = 4.07). Thus, participants who received topiramate were more likely to achieve longer periods of 'safe' drinking compared with those who received placebo.
CONCLUSIONS: For alcohol-dependent individuals who drank within an abstinence-oriented treatment program, topiramate promoted 'safe' drinking. Topiramate's potential to decrease the public health consequences of hazardous drinking needs to be established in future long-term studies.

RCT Entities:   Population Interventions Outcomes