Abstracts

Rationale: Levetiracetam (LEV) is an antiepileptic drug (AED) recently approved for the treatment of partial epilepsy as monotherapy. The aim of the present study was to perform a prospective evaluation of the efficacy and tolerability of LEV as monotherapy (1000 to 3000 mg/day) in adult patients with partial seizures refractory to a first AED, with a 6 month follow-up.Methods: Primary variables of efficacy were the percentage of responders (reduction of seizure frecuency > 50%) and the percentage of patients seizure free. As secondary variables of efficacy we asses the patient and the physician s opinion on treatment. We asses the tolerability profile through the spontaneous report of adverse events by patients and physicians. Results: We included 36 patients, 16 men and 16 females with a mean age of 36 19 years; 15 patients were between 16 and 30 years and 21 were over 30 years of age. The number of seizures (during the three months previous to the change of medication) was 8.6 12.6, with 16 patients having less than 5 seizures. With regard to the type of seizure, 26 presented SPS; 4, CPS; 6, SPS and CPS and in 13 cases were secondarily generalized. Regarding the etiology, 31 patients had idiopathic epilepsy and 5 patients had symptomatic epilepsy (secondary to stroke). The initial AED's that failed were CBZ/OXC 52%, PHT 26%, VAL 12%, other 10%. Five patients (13,8%) drop out (1 at 3 months; 2 at 4 months and 2 at 5 months) due to causes unrelated to adverse effects; 1 due to lack of efficacy. There were 91% of responders, (72% seizure free). Regarding the patient s opinion on treatment, 27 were greatly improved, 8 somewhat improved and 1 felt the same; and regarding to physician s opinion, in 29 patients they thought they were greatly improved, in 5 patients they felt they were somewhat improved and in 2 they were unchanged. Three patients presented adverse events: 2 somnolence and 1 dizziness.Conclusions: LEV showed to be effective in patients with partial seizure that failed to first AED with good tolerance in a short term study.