Wednesday, October 10, 2007

Topamax Effective in Reducing Heavy Alcohol Drinking

JAMA has an article this week by Bankole Johnson, et al., showing the anticonvulsant Topamax (topiramate) to be effective in reducing percentage of heavy drinking days, from 82% in the placebo group to 44% in the Topamax group.

This was a double-blind, placebo-controlled, 14-week study, using 371 study participants. Dose range was 50-300 mg daily. Side effects included tingling sensations, changes in taste, loss of appetite, and impairments in concentration. Mean daily dose was 171 mg/day. They started with 25 mg/d for Week 1, then 50 mg/day for week 2, and increasing by 50 mg weekly (in divided morning and night doses) to the maximum of 300 mg/d.

This may be a good approach to helping some people reduce drinking, especially folks who might also have bipolar disorder, which is sometimes also treated with Topamax.

"Our study had 3 limitations. First, while the pattern of adverse events was similar to that found in our previous study,3 the more rapid titration was associated with decreased study adherence with taking the medication. Previously, when topiramate was titrated over an additional 2 weeks (ie, over 8 weeks rather than 6 weeks), retention rates were similar between the topiramate and placebo groups. Clinical sites least familiar with topiramate experienced more difficulties with retention, whereas completion rates among some experienced groups approached 90% (data not shown). We advise clinicians to use the slower titration schedule and to provide participants with focused education on managing emergent adverse events to maximize adherence with taking the medication. Second, as with most clinical trials in the alcohol dependence field, enrolled participants have to meet criteria enabling the conduct of a safe study. Because this cohort is often relatively healthier and perhaps more homogeneous than the general population of all those seeking treatment for alcohol dependence, our ability to generalize without restriction from this trial to clinical practice is limited. Third, this study did not have a follow-up period, so we could not determine whether, how many, and at what interval participants would have relapsed following medication withdrawal. Nevertheless, with respect to how people fare, on average, following treatment for alcoholism in a clinical trial, a meta-analysis of recent studies has shown that, even after a single treatment event, most can show substantial reductions in drinking up to 1 year afterward.

Our finding in this study that topiramate is a safe and consistently efficacious medication for treating alcohol dependence is scientifically and clinically important. Alcoholism ranks third and fifth on the US and global burdens of disease, respectively. Discovering pharmacological agents such as topiramate that improve drinking outcomes can make a major contribution to global health. Because topiramate pharmacotherapy can be paired with a brief intervention deliverable by nonspecialist health practitioners, a next step would be to examine its efficacy in community practice settings.