Abstracts

Rationale: Adverse effects (AEs) of antiepileptic drugs (AEDs) may be overlooked in everyday clinical practice. The primary objective of the adverse Event SCAle in Patients with Epilepsy (aESCAPE) study was to explore in a systematic and standardized way the incidence and type of AEs experienced by patients with epilepsy treated with newer and older AEDs. Methods: This multicenter, observational, cross-sectional, non-interventional study investigated AEs in patients with epilepsy (aged ≥4 years), who were stable on 1-2 AEDs for at least 3 months, using standardized physician-completed questionnaires. Results: 1,019 patients (47.6% male), mean age 31.5 years (4-85 years) were enrolled in the study. 56.9% and 43.1% of patients were receiving 1 or 2 AEDs, respectively. 71.3% of patients took older AEDs (51.9% 1 older; 10.7% 2 older; 37.4% a combination of older and newer AEDs) and 28.7% took newer AEDs exclusively (69.5% 1 newer; 30.5% 2 newer AEDs). The most frequently used (≥10%) older AEDs were valproate (47.7%) and carbamazepine (23.7%); the most common newer AEDs were: lamotrigine (21.9%), levetiracetam (17.9%) and oxcarbazepine (11.2%). The median time since last treatment modification was 13.0 months. Overall, 68.3% patients reported ≥1 AE. Fewer patients on newer AEDs reported ≥1 AE than those on older AEDs (61.3% vs. 71.1%), and fewer patients on monotherapy reported ≥1 AE than those on polytherapy (66.0% vs. 71.3%). In the monotherapy group, AEs were reported by a lower proportion of patients on newer AEDs (61.6% vs. 68.4% on older AEDs). Overall, patients on newer AEDs were significantly less likely to report ≥1 AEs than those on older AEDs (OR 0.64, 95%CI 0.46-0.89, p=0.0079). Patients receiving newer AEDs had a significantly lower incidence of the following AEs compared with patients on older AEDs: disturbance in cognitive function, tremor, sedation, and changes in hair quantity/texture since starting drug (Table 1). Changes in treatment/dose occurred at the study visit for 22.8% (17.5% on newer AEDs; 24.9% on older AEDs) with most common reasons (newer vs. older): lack of efficacy (6.2% vs. 7.8%); AEs (4.1% vs. 8.4%); absence of seizures (3.8% vs. 4.0%). Levetiracetam- (n=182) or lamotrigine-treated patients (n=223) were significantly less likely to experience an AE (levetiracetam OR 0.33 [95% CI 0.19-0.56, p<0.0001]; lamotrigine OR 0.51 [95% CI 0.31-0.84, p=0.0082]) or modify treatment (levetiracetam OR 0.33 [95% CI 0.19-0.57, p<0.0001]; lamotrigine OR 0.52 [95% CI 0.32-0.85, p=0.0088]) than patients not on either treatment. Conclusions: Patients treated with newer AEDs were significantly less likely to report AEs than those treated with older AEDs. Patients treated with levetiracetam or lamotrigine were less likely to report AEs or to change treatment. Overall, a standardized AE instrument appeared to be useful for monitoring AEs and optimizing AED therapy. Study funded by UCB.