MULTICENTER OBSERVATIONAL STUDY OF LEVETIRACETAM IN SPAIN
Abstract number :
1.359
Submission category :
Year :
2004
Submission ID :
4387
Source :
www.aesnet.org
Presentation date :
12/2/2004 12:00:00 AM
Published date :
Dec 1, 2004, 06:00 AM
Authors :
1Jose M. Serratosa, 2Mar Carre[ntilde]o, 3Javier Salas-Puig, 4Antonio Gil-Nagel, and 5Jose Luis Herranz
To analyze the efficacy and safety of levetiracetam by means of an open-label, observational, transectional study. Patients with any type of seizure and epilepsy in whom treatment with levetiracetam was started in 8 centers were included in this study. The following data were analyzed at baseline: age, age at seizure onset, seizure types, type of epilepsy, monthly seizure frequency and number of antiepileptic drugs (AEDs) tried. After a minimum of 6 months of starting levetiracetam seizure frequency, side effects (type and duration), dose of levetiracetam, reasons for discontinuation of levetiracetam and concomitant AED use were analyzed. A total of 425 patients were included in the study. Mean seizure frequency at baseline was 17.6 seizures/month and mean number of AEDs tried was 5.8. The majority of patients (90.3%) presented partial seizures with or without secondary generalization. Mean duration of treatment with levetiracetam was 7.9 months and mean dose was 1,802 mg/day. At evaluation, 64.2% of patients had experienced a [gt]50% reduction in seizure frequency (including 25.4% of seizure free patients), 26.8% presented no changes in seizure frequency and 8.2% had an increase in seizure frequency. Side effects were reported by 111 patients (26,1%) and required withdrawing levetiracetam in 31. The most common side effects were somnolence (n=73), irritability (n=19), and depression (n=15). At the end of the study 35 patients (8.2%) were on monotherapy with levetiracetam. When only children or elderly patients were analyzed, similar results were obtained, although less children and more elderly patients achieved a [gt]50% reduction in seizure frequency and more elderly patients and less children presented side effects. In this observational study in close-to-clinical-practice conditions, levetiracetam proved to be an effective drug in 64% of patients. Side effects were usually mild, transitory and rarely severe enough to discontinue medication. Levetiracetam also proved to be effective and safe in children and elderly patients.