Pattern of adverse events of antiepileptic drugs: results of the aESCAPE study in Poland

INTRODUCTION: The Adverse Event Scale in Patients With Epilepsy (aESCAPE) European study (NCT00394927) explored and analyzed adverse events (AEs) and reasons for modifying treatment in patients treated with newer and older antiepileptic drugs (AEDs) used in monotherapy or polytherapy. The present analysis concerns the results of patients recruited in Poland. MATERIAL AND METHODS: Multicentre, international, observational, cross-sectional study investigating AEs in patients with epilepsy (aged ≥ 4 years), on stable AED treatment with one or two AED(s) for ≥ 3 months, using standardized questionnaires completed by a physician during a single study visit. RESULTS: Out of 309 patients, 24.6% were treated exclusively with newer AED(s) in monotherapy or in combination, while 75.4% were treated with older AED(s) or a combination of older and newer AED(s). 60.8% were on monotherapy, and 39.9% on polytherapy. In general, 73.8% of patients reported ≥ 1 AE(s). There were no significant differences in the frequency of reported AEs in compared groups. The most common were disturbances in cognitive function (40.5%), psychological problems (36.2%), and sedation (32.7%). Some AEs were found to be more specific for particular types and treatment regimens. Changes in treatment or dose during the study visit occurred in 22.3% of the patients, mainly due to lack of efficacy (10.7%), AEs (5.2%) or absence of seizures (4.5%). CONCLUSIONS: A detailed structured interview revealed high frequency of AEs in patients treated with AEDs. The main reasons for treatment modifications at the study visit were lack of efficacy, adverse events and absence of seizures.