Magazine article Drug Topics

Under Control

Magazine article Drug Topics

Under Control

Article excerpt

New antiepileptic called powerful in cutting seizures

A new agent that helps control epileptic seizures in difficult to treat patients has been approved by the Food & Drug Administration as adjunctive therapy. In addition, major studies of the potent compound as monotherapy are continuing.

Topiramate (Topamax, OrthoMcNeil Pharmaceutical) is indicated for use with standard medications for partial onset seizures, the most common type. These begin in one area of the brain and, if untreated, can spread through the entire brain causing generalized convulsions.

About 30% of epilepsy patients in the United States--some 650,000 people-still endure recurrent seizures even though they regularly take traditional antiepileptic drugs, including phenytoin, carbamazepine, and/or phenobarbital, or newer agents such as feldamate, gabapentin, and lamotrigine.

"In my experience with all these antiepileptics, topiramate is by far the most effective in reducing seizures," veteran investigator Michael Privitera, M.D., associate professor of neurology, University of Cincinnati Medical Center, told Drug Topics in an interview. "It's a very powerful drug, but not the easiest to use."

Patients involved in five worldwide placebo-controlled clinical trials of topiramate represented the most difficult treatment challenges, added Ortho-McNeil's clinical director, Marc Kamin, M.D. "The typical patient had 11 seizures per month and was getting little help from standard medications." All patients had to continue to take their regular medication during the trials. "There could be no adjustments in dosages of any drugs," Kamin emphasized.

The new compound reduced seizure frequency in many cases; some of the patients even became seizure-free. Kamin noted that in one study with 181 patients the recurrence of attacks was reduced by at least half in 44% of these patients-compared to 18% for placebo. In 22% of patients taking the recommended dose of 400 mg per day, the frequency of convulsions fell by more than 75%. (The trials had a range of doses, from 200 mg to 1,000 mg per day.)

Undesirable side effects are a problem with all anticonvulsant agents, and topiramate is no exception. "But the package insert-in which data are based on the trialsexaggerates the negatives because the trial dosages often were too high and we were not allowed to adjust them to fit patients' needs as physicians normally would do," said Privitera. …

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