10779/rcsi.10781645.v1 Vicente Villanueva Vicente Villanueva Martin Holtkamp Martin Holtkamp Norman Delanty Norman Delanty Juan Rodriguez-Uranga Juan Rodriguez-Uranga Rob McMurray Rob McMurray Patricia Santagueda Patricia Santagueda Euro-Esli: a European audit of real-world use of eslicarbazepine acetate as a treatment for partial-onset seizures. Royal College of Surgeons in Ireland 2019 Antiepileptic drug Clinical practice Epilepsy Eslicarbazepine acetate Pooled analysis Real world Clinical Pharmacology and Therapeutics 2019-11-22 16:15:27 Journal contribution https://repository.rcsi.com/articles/journal_contribution/Euro-Esli_a_European_audit_of_real-world_use_of_eslicarbazepine_acetate_as_a_treatment_for_partial-onset_seizures_/10781645 <p>The Euro-Esli study was an exploratory pooled analysis of data from 14 European clinical practice studies, which was conducted to audit the real-world effectiveness, safety, and tolerability of eslicarbazepine acetate (ESL) as an adjunctive treatment for partial-onset seizures. Retention and effectiveness were assessed after 3, 6, and 12 months of ESL treatment, and at the final visit. Safety and tolerability were assessed throughout ESL treatment by evaluating adverse events (AEs) and ESL discontinuation due to AEs. Data from 2058 patients (52.1% male; mean age 44.0 years) were included. All 2058 patients were assessed for safety and 1975 (96.0%) patients were assessed for effectiveness. After 12 months, retention, responder (≥50% seizure frequency reduction), and seizure freedom rates were 73.4, 75.6, and 41.3%, respectively. AEs were reported for 34.0% of patients and led to discontinuation in 13.6% of patients. The most frequently reported AEs were dizziness (6.7% of patients), fatigue (5.4%), and somnolence (5.1%). No unexpected safety signals emerged over a median duration of follow-up of >5 years. Subgroup analyses revealed that ESL was significantly more effective in patients aged ≥65 versusyears, in patients who were not receiving treatment with other sodium channel blockers versus those who were receiving treatment with other sodium channel blockers, and in patients who were receiving≥2 concomitant antiepileptic drugs at baseline. Euro-Esli is the largest ESL clinical practice study conducted to date. This study provides strong and reassuring evidence of ESL's safety profile, and complements the data from clinical trials.</p>