Normalization and cross-sectional validation of an extended Adverse Event Profile (E AEP) in a large cohort of patients with epilepsy.

The Liverpool Adverse Event Profile (L AEP) is commonly applied in clinical practice and pharmacological trials for the monitoring of side effects of anti-seizure medication (ASM). However, additional symptoms need to be assessed and normative data would be appreciated to put patients´ complaints into perspective. An extended 32-item AEP (E AEP) was given to 537 healthy subjects and 1,605 patients with epilepsy as part of the Bonn ASM side effect registry. The tool was factor-analyzed, normed with regard to age, gender, and repeated application, and related to drug load and individual substances (with N> 100) on item and scale level (total E AEP and its subscales cognition, dizziness, energy, mood, bodily symptoms, aggression, and sexuality). Compared to non-normalized results, on item level, between one and two-thirds less problematic responses were noted after normalization. Binary regression analyses revealed differential effects of antiseizure-drug treatment, but also of antidepressants and neuroleptics on complaint domains. The explained variance was better for bodily than psychic domains. The results reflect both known drug side effects and indications. Patients´ explicit attribution of problems to their drugs barely improved the correlation of the E AEP and treatment parameters. Application of a normed AEP is highly recommended to avoid an overestimation of treatment related problems in patients with epilepsy. It allows evaluation on item and scale level for individuals as well as groups in drug trials. Plausible relations to individual drugs and to drug load can be demonstrated. The explanatory power was better for physical than psychic domains. Drug-related complaint patterns reflect known drug side effects (e.g. perampanel and brivaracetam with aggression) as well as drug indications (e.g. lamotrigine for depression), the latter particularly when considerations of side effects found their way into treatment decisions. Longitudinal evaluation with repeated application of the E AEP along with changes of drug treatment is in progress.

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Copyright © 2023. Published by Elsevier Ltd.

Déclaration de conflit d'intérêts

Declaration of Competing Interest CH has nothing to declare in regard to the present work. Independent on this he received honoraria and travel support from UCB, Eisai, Jazz Pharma, Angelini, Desitin as well as license fees from UCB Japan and Eisai outside the presented work. CM, SM, SMH MR and RVW and JAW have nothing to declare in connection to the present work.