FDA Hasn't Approved Seizure Control Medication for Treatment of Alcoholism

By Shankar Vedantam, Washington Post Staff Writer
Friday, May 16, 2003; Page A02


A drug with a novel mechanism of action reduced the craving for alcohol among heavy drinkers and may help alcoholics quit or seriously reduce their drinking, researchers reported yesterday.


The medicine, topiramate, which is marketed to control seizures, was found to be effective in a trial with 150 volunteers conducted at the University of Texas at San Antonio, said lead investigator Bankole Johnson, a psychiatrist.


"We think it's very significant," he said in an interview. In a comparison of those taking the drug with those receiving placebo pills and behavioral counseling, the drug "is four times better in terms of heavy drinking and eight times better in terms of complete abstinence."


The Food and Drug Administration has not approved the medicine, which appears to affect the brain's ability to experience the pleasure of drinking and to reduce the craving for alcohol, for treating alcoholism.  The study would have to be replicated in larger groups before doctors could recommend it.


Still, federal researchers and others agreed that it could open a new front in the treatment of alcohol abuse, which afflicts about 14 million Americans -- one in every 13 adults. Alcohol abusers are defined as men who have five or more drinks per day and women who have four or more drinks each day.


Unlike traditional alcohol abuse studies, which usually examine the effectiveness of medicines and psychological interventions in keeping alcoholics from drinking at all, Johnson's study involved volunteers who were active heavy drinkers. The results were published in the Lancet medical journal.


"The results were very promising," said Raye Litten, chief of the Treatment Research Branch at the National Institute on Alcohol Abuse and Alcoholism.


Large studies are underway to measure the effects of combining other medications with a range of psychosocial therapies.


Topiramate may be especially effective in easing the symptoms of withdrawal, said Robert Swift, an alcohol abuse researcher at Brown University.


Doctors believe that most alcoholics require treatment with multiple approaches, including other medicines and psychological or religious techniques, to quit drinking and stay sober. Since many alcoholics go back to the bottle, doctors have come to mark victory against alcohol abuse in modest terms -- keeping people sober for periods of time rather than expecting them to quit permanently.


"Alcoholism is not a homogenous disease, so there is no magic bullet out there to treat" it, Litten said. "There is a biological component and a psychological component and a cultural component and a social component, and they vary from individual to individual."


Two medicines are approved to treat alcohol abuse -- disulfiram, sold under the trade name Antabuse, makes drinkers feel sick if they drink, while the better known naltrexone, sold as ReVia or Depade, appears to reduce the pleasure in drinking, Swift said.


Johnson pointed out that all the patients taking topiramate in his study -- even those still drinking -- were no longer consuming dangerous amounts of alcohol.


"We are able to get practically everybody drinking close to nothing, and the ones who are still drinking are not drinking as much," he said.


The study measured the effectiveness of topiramate -- which is sold under the brand name Topamax -- among 150 heavy drinkers. Half received the medicine and low-intensity counseling, while the other half received placebo pills and the same counseling.


The average person in the topiramate group was drinking 9.59 drinks a day upon beginning the study, compared with 8.85 drinks a day in the placebo group. Participants were asked to keep track of how much they drank, and even before they began taking medication their consumption dropped dramatically -- an indication of the role social factors play in alcohol abuse.


By the end of the three-month trial, patients taking topiramate were down to 1.5 drinks a day, while those taking the placebo were down to 3.36 drinks a day.


Johnson said 13 or 14 patients in the topiramate group quit entirely and stayed sober, while only two from the placebo group stopped drinking altogether.


Topiramate is sold in the United States by Ortho-McNeil Pharmaceutical of Raritan, N.J., which provided the pills and some funding. Most of the funding came from Johnson's own department. The researcher said he owns no stock in the company and would not financially benefit if the FDA approved the medicine for treating alcohol abuse.


Stephanie Scott, a spokeswoman for the company, said, "Right now, all we can say is the results are promising and would warrant some future investigation. We are not actively pursuing an indication for alcoholism for this compound."


Johnson's study did not report any severe side effects, but a recent study of topiramate in epileptics, conducted by Kimford J. Meador, chairman of the Neurology Department at Georgetown University Medical Center, found that some experienced severe side effects unless they started at low doses and built up gradually.

2003 The Washington Post Company©

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