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| |  Carisbamate Reduces Partial-Onset Seizures in Highly Refractory Patients, but Few Attain Seizure Freedom: Presented at AES By John Otrompke BOSTON -- December 6, 2009 -- The experimental drug carisbamate being studied for the treatment of partial-onset seizures in patients with epilepsy is well tolerated and significantly reduces seizures, although few patients experience freedom from seizures, according to results presented here at the American Epilepsy Society (AES) 63rd Annual Meeting. “These studies were done originally in folks with very intractable epilepsy,” said William E. Rosenfeld, MD, Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, Missouri. “If the drug was not working, they would go see another doctor or have surgery,” said Dr. Rosenfeld, during a poster presentation held on December 5. The median reduction in partial-onset seizures was 42.7%, with 40.8% of patients in the extension phase of the trial experiencing >= 50% reduction in frequency of partial-onset seizures. During the 18-month open-label period, 48% of patients withdrew, said Dr. Rosenfeld. To be included, patients had to have tried at least 3 prior antiepileptics. “The median number of prior drugs tried by patients was 6, and patients had been on anywhere from 2 to 18 drugs,” Dr. Rosenfeld explained. The study was an 18-month open-label extension of a 16-week, double-blind, dose-ranging study of carisbamate, in which the daily doses were repeatedly raised, lowered, and re-raised. The initial target dose was 400 to 800 mg, but could go up to 1,600 mg. Later the dose was capped at 800 mg during the extension period. However, the limit was subsequently raised again to 1,200 mg by the date of the presentation, Dr. Rosenfeld said. The dose was capped to balance side effects, such as dizziness or effect on liver function, with efficacy of the drug, he explained. In the study, 60% of patients received a modal dosage of between 400 and 800 mg/day, Dr. Rosenfeld said, adding that only 6% received a dosage of more than 1,200 mg/day. Of 537 patients originally randomised in the study, 80% were still on the drug at 6 months. At 1 year, the number was 68%, and at 18 months, 51% of patients were still in the study, Dr. Rosenfeld said. While most patients experienced a reduction in partial-onset seizures, only 2.9% of patients experienced no seizures at all on the drug. Behavioural or psychiatric adverse effects occurred in 13% of patients, while cognition-related adverse effects occurred in only 2%. Three deaths were reported: 2 in patients on the drug (1 due to a seizure; 1 due to sudden unexpected death), and another death within 3 days of the last dose. This study was funded by Johnson and Johnson Pharmaceutical Research and Development, LLC. [Presentation title: Carisbamate as Adjunctive Treatment of Partial Onset Seizures in Adults: Results at 18 Months From an Ongoing Open-Label Extension of a Double-Blind, Randomized, Dose-Ranging Study. Abstract 1.134]
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