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Spectrum of patients with refractory epilepsy: Local analysis of clinical evaluation of SKATE in the Czech Republic

Publication at First Faculty of Medicine, Second Faculty of Medicine |
2005

Abstract

The objective: Evaluating tolerance and efficacy of the levetiracetam administration in routinely followedup patiens with insufficiently compensated partial epileptic seizures. Methods: Results of the Czech part of the international clinical assessment of SKATE have been presented.

This was an open 16-weeks' multicentric clinical evaluation of the IVth phase in routinely folio wed-up patients with epilepsy above 16 years with insufficiently compensated partial fits. At the beginning of the clinical assessment, the patients were administered levetiracetam (LEV) in the dosis of 500 mg twice a day (the total dosis was 1000 mg/day).

During clinical evaluation, the levetiracetam dosis was titrated by 1000 mg/day up to the maximum doses of 1500 mg twice a day (the maximum dosis of LEV was 3000 mg/day) with the aim to achieve the seizure control under the maintained LEV tolerance. The principal results of the clinical assessment were as follows: "retention rate", "responder rate" (compared with the initial period) in partial seizures/week, total evaluating the changed severity of the disease ("Global Evaluation Scale") and undesirable events in the course of clinical assessment.

Results: Out of 92 patients involved in the Czech analysis, 91.3 % completed he whole clinical evaluation. The median of decreasing the number of partial seizures was 49.25 %.

Eor patients with partial fits there were "responder rate >50 %", 49.5 %, and "responder rate 100 %" (patients without seizures) 12.1 %. Undesirable results were mostly of mild up to middle intensity, total weakness. somnolence, headache and vertigo were reported most frequently.

Conclusion: LEV is an effective therapeutical preparation with very good tolerance for adjuvant treatment of refractory partial epileptic seizures in routinely followed up patients.