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Seizure drug improves abstinence from drinking, study shows

San Antonio (May 15, 2003) — Hailed as a landmark discovery that is likely to change the direction of clinical alcoholism treatment, researchers at The University of Texas Health Science Center at San Antonio have found that topiramate, a derivative of the naturally occurring sugar monosaccharide D-fructose, is effective at promoting abstinence among alcohol-dependent individuals.

Reported in the May 17 issue of The Lancet, this study conducted by Professor Bankole A. Johnson, M.D., Ph.D., and colleagues was carried out at the Health Science Center's dynamic South Texas Addiction Research & Technology (START) Center, where more than 100 professionals develop new medications for treating alcohol and drug dependence. Dr. Johnson is the William and Marguerite Wurzbach Distinguished Professor at the Health Science Center, professor of psychiatry and pharmacology, deputy chairman for research in the department of psychiatry, chief of the division of alcohol and drug addiction, and START Center director.

"Remarkably, all 150 patients were enrolled into this clinical trial while they were still drinking heavily (defined as more than five standard drinks a day for men and more than four for women)," Professor Johnson said. "Next, these patients were randomized to receive either oral topiramate (up to 300 milligrams a day) or the placebo for three months along with a minimum intervention behavioral treatment. Patients who took topiramate were six times more likely than those who received placebo to be continuously abstinent for at least one month during the three-month trial. Over the same period, those taking the placebo were four times more likely to drink heavily for an entire month during the trial."

Alcohol-dependent patients frequently have liver disease, one indicator of which is a rise in the plasma level of the enzyme gamma glutamyl transferase (GGT). "It is of considerable clinical importance that topiramate was superior to placebo at significantly reducing the plasma GGT levels during the trial," Professor Johnson said. "Further, topiramate was shown to be effective treatment for all types of alcohol-dependent patients." Topiramate already is an approved anti-seizure drug.

Leading researchers in the field welcomed the news. "Professor Bankole Johnson and colleagues have made a landmark discovery by demonstrating the utility of topiramate in the treatment of alcohol dependence," said Domenic Ciraulo, M.D., professor and chairman of the department of psychiatry at Boston University. "This finding is a major scientific advance in the treatment of alcoholism, and considerably increases our understanding of the neurobiology of the alcoholism disease process. The research design used, which enrolled drinking patients who plan to become abstinent, affords the practical innovation of delivering immediate help to those in crisis. The results of this remarkable study open up new and exciting directions for the pharmacological treatment of alcohol dependence."

"The strength of their findings is likely to change the direction of clinical alcoholism treatment and will be welcome news for practitioners," said Robert Malcolm, M.D., of the Center for Drug and Alcohol Programs at the Medical University of South Carolina, where he is associate dean and professor of psychiatry and family medicine. He said "the results of Professor Johnson's study suggest that topiramate, even in low doses early in treatment, has the capacity to ameliorate the turbulence of anxiety and mood instability that accompanies cessation from alcohol. Topiramate also produced a robust effect on improving maintenance of abstinence and reduced alcohol use. A single pharmacologic agent that enhances early abstinence, stabilizes mood and anxiety symptoms, and promotes long-term abstinence with only modest psychosocial intervention is indeed a remarkable treatment advance."

R. Adron Harris, Ph.D., the M. June and J. Virgil Waggoner Professor and director of the Waggoner Center for Alcohol and Addiction Research at The University of Texas at Austin, said topiramate is from a different class of drug than those previously used in the treatment of alcoholism. "It offers a new choice for alcoholism," he said. "Certainly not every patient will benefit from this drug or others, but because it is a different kind of drug than what is currently approved or in trials, it offers the possibility of bringing benefits to patients for whom other drugs are not successful. If this were a 'me-too' drug, or a variation on an existing drug, it would not be as important as a new class of drug being applied in this way."

Otto Michael Lesch, M.D., Ph.D., secretary of the European Society of Biomedical Research on Alcoholism, said scientists should confirm the finding in an American-European-Australian trial. He said "this study is much better than other studies," but noted that further clinical trials are needed to identify the optimum dosage of topiramate in the treatment of alcohol dependence.

"Although at present we have few pharmacologic agents to treat alcoholism, research groups such as Professor Johnson's are working hard to provide new treatment alternatives," said Raye Z. Litten, Ph.D., chief, Treatment Research Branch, National Institute on Alcohol Abuse and Alcoholism (NIAAA). "If this promising finding is replicated and topiramate is approved by the FDA (U.S. Food and Drug Administration), it should bring new hope to many who struggle with this devastating disorder."

Charles L. Bowden, M.D., professor of psychiatry and pharmacology and the Nancy Ullman Karren Chair in Psychiatry at the Health Science Center, said "the evidence of topiramate's benefits on cessation of alcohol dependence is noteworthy on two intriguing accounts. Not only was self-reported drinking reduced, but a strictly objective lab test measure for evidence of recent alcohol use (plasma GGT) showed the benefit of topiramate."

The investigation team included Nassima Ait-Daoud, M.D.; Professor Bowden; John D. Roache, Ph.D.; Kevin Lawson, Ph.D.; Martin A. Javors, Ph.D.; and Jennie Z. Ma, Ph.D., all of the START Center at the UT Health Science Center, and Carlo C. DiClemente, Ph.D., professor and chairman of psychology at the University of Maryland.

Nearly 14 million Americans — 1 in every 13 adults — abuse alcohol or are alcoholic, according to the NIAAA. Several million more adults engage in risky drinking that could lead to alcohol problems. This behavior includes binge drinking and heavy drinking on a regular basis. In addition, 53 percent of men and women in the United States report drinking problems in close relatives. Alcohol-related problems cost society about $185 billion per year, the NIAAA estimates.

Contact: Will Sansom or Aileen Salinas