Skuteczność i bezpieczeństwo brivaracetamu u pacjentów z ogniskową epilepsją: przegląd systematyczny i metaanaliza

OBJECTIVE: To systematically evaluate the effectiveness and safety of brivaracetam (BRV) as adjunctive therapy for focal epilepsy. METHODS: Electronic databases (PubMed, Proquest, Web of Science, Clinical Trials, and Cochrane Library) were searched without date restriction. RCTs and observational studies of patients with focal epilepsy receiving adjunctive BRV that reported responder rates were included. Title, abstract and the full text were checked independently and in duplicate by two reviewers. Disagreements were resolved through discussion. One author extracted data which was verified by a second author using identified common standard in advance, including using a risk of bias tool we agreed on to evaluate study quality. RESULTS: Twenty-two studies (7 RCTs, 15 observational studies; 8150 patients) were included. The pooled responder rate was 44.0% (95% CI: 36.0%-51.0%). Subgroup differences were significant for study design and duration of epilepsy (P < 0.05), but not for male proportion, age, or sample size (P > 0.05). Treatment-emergent adverse events were common (53.9%-79.3% in RCTs), predominantly somnolence, dizziness, fatigue, and headache. Serious adverse events and discontinuation due to adverse events were both infrequent (<10%), with no novel safety signals. CONCLUSIONS: Adjunctive BRV achieves a pooled responder rate of 44.0%, with results stable on sensitivity analysis. Longer duration of epilepsy may be associated with reduced effectiveness. BRV exhibits an acceptable safety profile, supporting its use as an adjunctive option for focal epilepsy.