To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: AES: Keppra (Levetiracetam) Safe, Effective In Elderly With Epilepsy URL: http://www.pslgroup.com/dg/20F44E.htm Doctor's Guide December 4, 2001
PHILADELPHIA, PA -- December 4, 2001 -- New data demonstrates the efficacy of Keppraź (levetiracetam), an anti-epileptic drug (AED), as add-on therapy in treating refractory epilepsy in elderly patients, according to a study presented today at the 55th American Epilepsy Society annual meeting in Philadelphia. The data revealed that Keppra patients older than 50 years had a higher rate of seizure freedom than the total patient population in the study (19 percent vs. 12 percent and 15 percent vs. 9 percent, respectively). The study, conducted by Guenter Kramer, M.D., Medical Director of the Swiss Epilepsy Centre, was designed to evaluate the efficacy and tolerability of Keppra in treating epilepsy in patients older than 50 years. The investigators analyzed data for patients with epilepsy who were taking Keppra during the drug's developmental program and isolated the data on those patients who were older than 50 years. The cutoff date for the data analysis was June 30, 1999, at which point, responder rates (greater than or equal to 50 percent and greater than or equal to 75 percent seizure reduction) and seizure freedom for the last 6 months and the last year were calculated. Tolerability was determined by the number of adverse event (AE) reports. "The data shows that Keppra is safe and effective as an add-on therapy for seizure reduction in the elderly patient population, while also revealing that this specific age group demonstrated higher seizure freedom rates than the total patient population studied," said Dr Kramer. "Given the rising incidence and prevalence of epilepsy among the elderly, the data is especially encouraging for healthcare professionals who treat these patients and need effective ways to reduce the frequency of their seizures." "Additionally, while efficacy has been demonstrated for other antiepileptic drugs, their use is usually limited by increased adverse events in this population. As the elderly are often on more than one medication, Keppra has increased benefits due to its lack of drug-drug interactions." From 1,422 total patients, the investigators isolated a subgroup of 211 patients with refractory epilepsy who were older than 50 and being treated with Keppra (median age 56 years, range 50-78 years). The median dose of Keppra administered was 3,000 milligrams per day, and the mean duration of exposure was 697 days. Forty-four percent of the patients were prescribed one other AED, and 43 percent were prescribed two other AEDs. At the end of the observation period, 44 percent of the elderly patients were still being treated with Keppra. Among those who were no longer being treated, the discontinuation of therapy rate was comparable to that seen in the total patient population, specifically: adverse events (20 percent), insufficient therapeutic effect (16 percent), completion of the study in which the patient was enrolled (12 percent) and other reasons such as protocol violation. The median seizure reduction from baseline was 44 percent (vs. 40 percent in the total population). The percentage of patients who had a seizure reduction of 50 percent or more, or of 75 percent or more, were comparable to those of the total patient population (37 percent vs. 39 percent and 19 percent vs. 20 percent, respectively). Seizure freedom during the six months prior to the final evaluation and during the last year was more prevalent in the elderly (19 percent vs. 12 percent and 15 percent vs. 9 percent). In the subgroup of 71 patients on only one concomitant AED, 34 percent (versus 20 percent in the total population) were seizure free during the six months prior to the final evaluation. Patients who received Keppra for less than six months or less than one year, but were seizure free throughout treatment with Keppra, were counted as seizure free. AEs were mainly CNS-related and mild. The incidences were comparable to the total population including somnolence (26 percent vs. 23 percent), asthenia (23 percent vs. 23 percent) and dizziness (18 percent vs. 19 percent). Other CNS-related AEs expected to be higher in an elderly population such as confusion (6 percent vs. 4 percent), hostility (1 percent vs. 4 percent), emotional lability (3 percent vs. 4 percent) and insomnia (9 percent vs. 7 percent) were not very different from the total population. There was no evidence of idiosyncratic side effects. The U.S. Food and Drug Administration approved Keppra tablets in November 1999 as an adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. SOURCE: The Swiss Epilepsy Centre --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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