Abstracts

Rationale: Randomized clinical trials (RCT) are mandatory for regulatory issues. However, real-life studies provide information about drug use in clinical practice. This work analyzes real-life experience with Brivaracetam (BRV) in a large series of patients with epilepsy  Methods: Briviact-life is a multicenter, retrospective, observational study. Inclusion criteria are: 1) patients older than 16 years; 2) partial-onset seizures; 3) Treatment with brivaracetam according to clinical practice. Patients were excluded if clinical records were not reliable or if they were enrolled in other studies. At this interim analysis all patients were required to have a minimum follow-up of three months since the onset of BRV. The source of data was patient clinical records and time-points for revision in this interim analysis were baseline and 3 months. Prior comorbidities, dosage, titration, effectiveness and safety were evaluated. Moreover an additional analysis in patients switched from levetiracetam (LEV) to BRV was performed. Results: A total of 439 patients were included but only the 298 patients that met inclusion/exclusion criteria and a follow-up of at least three months were considered for analysis. Prior to inclusion 112 patients (37.8%) had a prior psychiatric condition, 96 patients (32.5%) had a learning disability and 56 patients (12.7%) a concomitant medical comorbidity. The median number of seizures per month at onset was 5.3 and the median number of prior antiepileptic drugs (AED) was 8 and 61.4 % of the patients were taking >2 concomitant AEDs. The median daily dose at onset (first day) was 50 mg and 100 mg at 3 months, with a median titration period of 15 days. Retention rate was 90.3% at 3 months (2.7% discontinued because of lack of efficacy, 4.7% because of adverse events and 3% for both reasons). At 3 months 15.8% were considered as seizure-free, 39.8% as ≥50% responder and 7.4% reported a worsening. The median number of seizures per month was statistically significant reduced at 3 months (median 3.3 p < 0.001). Adverse events (AE) at 3 months were reported by 27.9 % (mild 10.4%, moderate 11.7% and 1.7% considered as severe). The most frequent AE were somnolence (7%), irritability (6.4%) and dizziness (4.7%%). One hundred sixteen patients changed from LEV to BRV, performing an overnight switch 32 patients (27.6%) and 84 patients (72.4%) a progressive transition. The median daily dose of BRV at onset (first day) was 50 mg and 200 mg at 3 months, with a median titration period of 21 days. The median daily dose of LEV before switching was 2000 mg so the dose equivalence at 3 months BRV:LEV was 1:10. Ninety-three patients (80.2%) switched because of lack of efficacy, 5 patients (4.3%) because of adverse events and 18 patients (15.5%) for both reasons. Considering  patients that switched from LEV to BRV because of lack of efficacy, 13.1% were considered as seizure-free, 38.3% as ≥50% responder and 9.4% reported a worsening at 3 months. In the group of patients that switched from LEV to BRV because of adverse events, 40.7% reported adverse events (14.8% mild, 22.2% moderate and 3.7% severe). The most frequently reported adverse events were irritability 11.1% and dizziness 11.1%. From the 17 patients that switched form LEV to BRV because of behavioral side-effects only 3 patients (17.7%) continued reporting this type of adverse events. Conclusions: Results after 3 months in a real-life refractory population treated with BRV showed a response similar to RCT. Adverse events were reported in few patients being most of them considerate mild or moderate. Additional effectiveness and improved tolerability, particularly in terms of psychiatric adverse events, were observed in patients that switched from LEV to BRV. Funding: No funding