[Open-label, prospective and observational study of efficacy and tolerability with levetiracetam during one year of follow-up].

Abstract Analyze efficacy and tolerability of levetiracetam under clinical practice conditions. An open-label, observational and prospective study with a one-year follow-up period, was conducted. All the patients in whom treatment was initiated with levetiracetam between January 2002 and January 2004 in the site where the study was conducted were included. The patients were evaluated in the baseline visit and months 1, 3, 6 and 12. The following were collected in the baseline visit: age, gender, age at onset of the episode, types of episodes, type of epilepsy, etiology, monthly rate of episodes and number of anti-epileptic drugs (AED) used. During the follow-up visits, episodes, adverse effects and concomitant AED were counted. Analysis was conducted by intention-to-treat (ITT) and in the patients who completed one year of follow-up. One hundred eight patients were enrolled in the study. Most had partial complex seizures (63.1 %) and partial epilepsy (88 %). Eighty-one patients completed the one year of follow-up (75 %). In relationship to the ITT, the percentage of responders was 63 % and the percentage of seizure-free patients 35.2 %. These percentages remained stable during the study. Secondary effects were maintained in 21 patients (19.4 %), resulting in withdrawal in 9 patients (8.3 %). The most frequent adverse event was somnolence. Monotherapy was achieved with levetiracetam at the end of the one year of follow-up in 18 patients (16.7%) This study shows the efficacy and tolerability, which rarely led to withdrawal, of levetiracetam under conditions of clinical practice.