Eslicarbazepine acetate as adjunctive therapy in clinical practice: ESLADOBA study

Abstract

ObjectiveTo assess seizure control and tolerability of eslicarbazepine acetate (ESL) as adjunctive therapy to one baseline antiepileptic drug (AED), in adults with partial‐onset seizures (POS) with or without secondary generalization.MethodsMulticenter, non‐interventional, prospective cohort study conducted between March 2012 and September 2014 at 12 neurology departments in Portugal. Adults with POS not controlled with one AED who had initiated ESL as adjunctive treatment were enrolled. Retention rate was defined at the final visit (Vfinal) 6‐9 months of follow‐up. Proportion of responders, seizure‐free, changes in seizure frequency were evaluated using patients' diaries. Clinical Global Impression of Change (CGI‐C) and Clinical Global Impression of Severity (CGI‐S) were assessed by the neurologist.ResultsFifty‐two patients (48.1% male) were included with mean age 41.5±13.3 years. Mean epilepsy duration was 18.5±14.8 years; mean seizure frequency in the four previous weeks to baseline was 7.5±12.7. At Vfinal, retention rate was 73.0%; responder rate and seizure‐free rates were 71.1% and 39.5%, respectively. The median relative reduction in seizure frequency between baseline and Vfinal was 82.2%. A reduction in epilepsy severity (CGI‐S) was observed in 42.1%. According to CGI‐C, 73.6% patients had their epilepsy “much improved” or “very much improved”. Twelve patients (23.1%) had at least one adverse event (AE), two (3.9%) had one serious AE, and five (9.6%) discontinued due to AE.ConclusionsEslicarbazepine acetate showed good retention rates, elicited a significant reduction in seizure frequency, and was well tolerated when used in the clinical practice.

Real‐world experience with direct brain‐responsive neurostimulation for focal onset seizures

“…A secondary outcome measure was overall impression of response to treatment using the Clinical Global Impressions Scale (CGIS), a clinician‐determined summary measure of the patient's ability to function 10 that has been used in other epilepsy therapy trials 11 . Antiepileptic drugs (AEDs) were also documented at each time point.…”

Eslicarbazepine acetate as monotherapy in clinical practice: Outcomes from Euro-Esli

“…The Euro-Esli study was an exploratory, retrospective, pooled analysis of data from European clinical practice studies, [9][10][11][12][13][14][15][16][17][18][19][20][21] conducted to audit the effectiveness, safety, and tolerability of ESL as an adjunctive treatment for focal-onset seizures in clinical practice, details of which have been published previously. 8 In brief, effectiveness was assessed after 3, 6, and 12 months of ESL treatment and at final follow-up, and safety and tolerability were assessed for the duration of ESL treatment.…”

The ROME (Retrospective Observational Multicenter study on Eslicarbazepine) study: Efficacy and behavioural effects of Eslicarbazepine acetate as adjunctive therapy for adults with partial onset seizures in real life

“…Adverse effects (AE) reported in clinical trials were dose-dependent [16] and mainly involving central nervous (diplopia, dizziness, headache, vertigo and somnolence) and gastrointestinal system. Validation trials reported few serious ESL-related AEs and these events were generally mild to moderate, predictable, manageable and occurring during the early stages of treatment [17][18][19]. Compared to other dibenzazepines the major adverse effect appears to be hyponatremia (defined as any report of Na 135 mmol/l); during phase III studies hyponatremia was found in 18% of the patients receiving ESL, in particular on those patients with significant comorbidities and poly-therapy, versus 6% in patients receiving placebo [20].…”