Initial monotherapy with eslicarbazepine acetate for the management of adult patients with focal epilepsy in clinical practice: a meta-analysis of observational studies Fernández Anaya, Silvia Rico-Villademoros, Fernando Antiepileptic drug Epilepsy Eslicarbazepine acetate Focal seizures Monotherapy Systematic review This study was funded by Laboratorios Bial, S.A. (Madrid, Spain). The authors thank Alejandro Pedromingo (Bio-estadistica. com, Madrid, Spain) for the statistical analysis, and Isabel San Andrés (Incimed, Madrid, Spain) for performing the literature search. Their participation has been funded by Laboratorios Bial, S.A. (Madrid, Spain). Aim of the study To assess the effectiveness, overall tolerability of eslicarbazepine acetate (ESL) as an initial or early monotherapy treatment of adult patients with focal epilepsy under real-world practice conditions. Materials and methods We focused on real-world longitudinal studies that included or separately reported the results of at least one of the efficacy outcomes of interest. A DerSimonian-Laird random effects model was used with the presentation of the 95% confidence intervals of the estimate Results 5 studies met our selection criteria and were included in the quantitative synthesis. All studies were observational and uncontrolled studies, and all but one were retrospective studies. The pooled proportion of patients who were seizure-free for the entire study period was 64.6% (95% CI, 45.7 to 79.8) at month 6 and 56.6% (95% CI, 50.2 to 62.8) at month 12. Pooled retention rates were 95.0% (95% CI, 90.3 to 97.5) at 6 months and 83.6% (95% CI, 73.9 to 90.1) at 12 months. The pooled proportion of patients who reported at least one adverse event was 27.2% (95% CI, 21.7 to 33.6), and the pooled proportion of patients who discontinued ESL due to adverse events was 8.9% (95% CI 6.2 to 12.6). Conclusions Our results suggest that initial or early monotherapy with ESL is effective and well-tolerated for the management of adult patients with focal epilepsy in clinical practice, with results that are at least similar to those reported in the pivotal randomized clinical trial of ESL monotherapy. No new safety signals with ESL have been identified in this systematic review. 2021-06-16T10:37:57Z 2021-06-16T10:37:57Z 2021-06-01 info:eu-repo/semantics/article Silvia Fernández-Anaya... [et al.] (2021) Initial monotherapy with eslicarbazepine acetate for the management of adult patients with focal epilepsy in clinical practice: a meta-analysis of observational studies, International Journal of Neuroscience, DOI: [10.1080/00207454.2021.1925667] http://hdl.handle.net/10481/69232 10.1080/00207454.2021.1925667 eng http://creativecommons.org/licenses/by-nc-nd/3.0/es/ info:eu-repo/semantics/openAccess Atribución-NoComercial-SinDerivadas 3.0 España Taylor & Francis