Treatment-emergent adverse events and antiseizure medication actual drug load

• DOI: 10.1016/j.yebeh.2022.108980
• Publication Date: 2022-11-11T17:50:18Z
• Authors: Tiffany Prétat; Irene Aícua-Rapún; Pascal André; Sebastien Lebon; Andrea O. Rossetti; Laurent A. Decosterd; Thierry Buclin; Jan Novy
• Keywords: Clinical Trials as Topic; 03 medical and health sciences; Epilepsy; 0302 clinical medicine; Body Weight; Humans; Humans; Body Weight; Epilepsy/drug therapy; Clinical Trials as Topic; Adverse events; Antiepileptic drug; Antiseizure drug; Tolerability; Treatment discontinuation; 3. Good health

The correlation between treatment-emergent adverse events (TEAE) and antiseizure medication (ASM) drug load is a controversial topic. Previous studies used daily defined dosage (DDD) to measure drug load. We aim to assess if ASM adjusted to body weight and plasma levels were associated with TEAE.We analyzed clinical visits of a trial on therapeutic drug monitoring in outpatients with epilepsy. TEAE, treatment, and its changes, as well as ASM plasma levels, were recorded at each visit. Each medication level was stratified according to its position in relation to its proposed reference range (below, in the lower half, upper half, or above).We analyzed 424 visits (151 participants). Treatment-emergent adverse events were reported in 84 (20%) visits. There was no significant difference when comparing visits with TEAE with those without TEAE in terms of ASM drug load (calculated with DDD), corrected for body weight, their changes since the last visit, as well as summed plasma levels compared to reference ranges.Actual drug load seems not to represent a major determinant of TEAE recorded during routine visits, even when accounting thoroughly for the patient's exposure to the treatment. The use of structured questionnaires and neuropsychometric tests may assess more accurately the potential consequences of drug loads.