CHICAGO Topamax, a drug commonly used to prevent migraines, helped reduce the number of days alcoholics spent binge drinking, U.S. researchers said on Tuesday, suggesting the drug should be studied further.
The study was funded by Johnson & Johnson, which makes Topamax, or topiramate, a drug that is also approved to treat seizures.
Researchers tested Topamax in 371 men and women aged 18 to 65 with alcohol dependence in 17 U.S. cities.
"The individuals are being treated at a point of maximum crisis, when they are drinking severely," said Dr. Bankole Johnson of the University of Virginia in Charlottesville, whose study appears in the Journal of the American Medical Association.
Men in the study drank 35 or more standard drinks per week and women drank 28 or more standard drinks per week in the 28-day period prior to being screened for the 14-week study, which took place between January 2004 and August 2006.
Researchers defined a standard drink as a half ounce of absolute alcohol, or the equivalent of a 10-ounce beer or a 4-ounce glass of wine. Half of the patients got a drug and half got a placebo and all got a 15-minute weekly counseling session.
The percentage of heavy drinking days fell in both groups by the 14th week of the study, but the reduction was greater in the Topamax group, where heavy drinking days fell to 43.8 percent from 81.9 percent.
In the placebo group, the percentage of heavy drinking days fell to 51.8 percent from 82 percent.
A heavy drinking day was defined as five or more drinks for men and four or more for women.
WATCHDOG GROUP'S CONCERNS
Topamax was more likely to cause side effects with about half who got the drug experiencing abnormal skin sensations such as tingling and numbness, compared with about 10 percent in the placebo group.
Other side effects included difficulty concentrating and anorexia. About 30 percent of study participants dropped out, mostly because of the side effects, Johnson said.
An analysis that excluded the dropouts showed a 16 percent reduction in binge drinking among those who took Topamax compared with the placebo group.
Johnson said the drug shows promise given that current treatments require alcoholics to stop drinking before they can get a drug to keep them sober.
But consumer watchdog group Public Citizen said the benefit was modest and charged that promotional materials accompanying the study suggest doctors could prescribe the drug to alcoholics as a so-called off-label treatment.
In a letter sent to U.S. Food and Drug Administration Commissioner Dr. Andrew von Eschenbach, Public Citizen noted that background materials sent out by the University of Virginia suggest the drug "is available to your doctor to prescribe it to you off-label."
J&J spokeswoman Kara Russell said the company had not seen the materials and said J&J was not marketing Topamax as a treatment for alcoholism.