Levetiracetam in Refractory Epilepsy: Predictors of Long-Term Retention
Abstract number :
3.183
Submission category :
Year :
2000
Submission ID :
807
Source :
www.aesnet.org
Presentation date :
12/2/2000 12:00:00 AM
Published date :
Dec 1, 2000, 06:00 AM
Authors :
Karsten Krakow, C Otoul, M C Walker, J W Sander, Goethe Univ Frankfurt, Frankfurt, Germany; UCB Pharma, Braine L'alleud, Belgium; Institute of Neurology, Loondon, United Kingdom; Institute of Neurology, London, United Kingdom.
RATIONALE: The long-term retention rate of an antiepileptic drug can be considered as a composite measure of tolerability and efficacy. In this study, the retention rate of the novel antiepileptic drug levetiracetam (LEV) in patients with refractory epilepsy was evaluated. METHODS: Data of all patients with epilepsy exposed to LEV during the developmental programme of the drug were analyzed. The retention rate was analyzed using the Kaplan-Meier method. A Cox regression model was used to identify predictors of a higher retention. RESULTS: Data until a cut-off data June 1, 2000 will be presented. Until June 1, 1999 1422 patients with refractory epilepsy were exposed to LEV (median age 36.0 years, range 5-78 years), the median LEV dose was 3000 mg/day. The mean duration of exposure was 622 days (range 1-2984 days). 40% of patients were still treated at the end of the observation period, in 14% of patients the treatment was terminated because of adverse events, in 18% because of lack or loss of efficacy. The LEV retention rate was estimated to be 60% after the first year, 37% after three years and 31% after five years. The median seizure reduction from baseline was 40%. 39% of patients had a seizure reduction of 50% or more, 20% of patients of 75% or more. 13% of patients became seizure free for at least 6 months, 8% for at least one year. The Cox regression model identified four factors which were correlated with higher retention rates: (1) higher maintenance doses of LEV, (2) lower starting doses of LEV, (3) presence of convulsive seizures, (4) presence of only one concomitant antiepileptic drug. LEV was generally well tolerated, adverse events were mainly CNS-related and mild, including somnolence and dizziness. There was no evidence for idiosyncratic side effects. No tolerance to the effects of LEV has been noted. CONCLUSIONS: LEV is an effective and well tolerated new antiepileptic drug. Both the long-term retention rate and the potential to achieve freedom of seizures in patients with refractory epilepsy seem to be higher than in other new antiepileptic drugs.