First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study.

Brivaracetam (BRV) is the latest approved antiepileptic drug and acts as a synaptic vesicle protein 2A ligand. The aim of the present study was to evaluate the efficacy and tolerability of BRV in the clinical setting. Retrospective, observational multicentre study. We retrospectively collected clinical data of patients who received BRV in 10 epilepsy centres using a questionnaire that was answered by the reporting neurologist. Data of 615 epilepsy patients treated with BRV were included in the study. Efficacy regarding seizure frequency and tolerability of BRV were evaluated. Descriptive statistics complemented by X Overall, 44% of the patients had a decreased, 38% a stable and 18% an increased seizure frequency. 17% of patients achieved seizure freedom after initiation of BRV. The seizure frequency decreased in 63% of 19 patients with BRV monotherapy. 27% reported adverse effects, but only 10% of patients with monotherapy. Brivaracetam was significantly more often associated with decreased seizure frequency in levetiracetam (LEV) naïve patients (p=0.012), but BRV also led to a decreased seizure frequency in 42% of patients who had been treated with LEV before, including 17% of patients who were completely seizure free. Adverse effects under LEV improved in 62% and deteriorated in 2% of patients after the switch to BRV. At latest follow-up (mean±SD = 26.3±6.5 months), 68% were still on BRV. The present study shows that results of the phase III studies on BRV match data from real life clinical settings. Brivaracetam seems to be a useful alternative in patients who have suffered adverse effects while taking LEV.

Informations de copyright

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: KM has received honoraria as advisory board member from Eisai and UCB. FR has received personal fees from Bayer-Vital, Cerbomed, Eisai, Hexal and Sandoz, personal fees and support for continuing medical education activities from Desitin, Novartis, Shire and UCB Pharma and grants from DFG (German Research Foundation) and the European Union. SS-B reports personal fees from UCB, Eisai, Desitin Pharma, LivaNova, Bial, Novartis and Zogenix outside of the submitted work. FVP reports industry-funded travel with support of Desitin Arzneimittel, UCB Pharma, Eisai Pharma and BIAL, obtained honoraria for speaking engagements from Desitin Arzneimittel, UCB Pharma, Eisai Pharma and BIAL and was part of a speaker’s bureau of Desitin Arzneimittel, UCB Pharma and BIAL. RK reports industry-funded travel with support of Eisai Pharma and Desitin Arzneimittel. MH has received honoraria for lectures from pharmaceutical companies (Eisai, UCB) and research support for participation in clinical trials and registries from Medtronic, Cyberonics and Precisis. TM has received travel expenses for attending a meeting from UCB Pharma. YW received travel grants and honoraries for lectures from UCB Pharma, BIAL, Eisai, Bayer and Novartis, which were not related to the publication. LL has received lecture honoraria from Eisai. MC has received travel expenses for attending meetings from Desitin and Zogenix. AS reports personal fees and/or grants from Desitin Arzneimittel, Eisai, GW Pharma, LivaNova, Medtronic, Sage Therapeutics, UCB Pharma and Zogenix. SK reports honoraria for speaking engagements from Desitin and UCB as well as educational grants from AD Tech, Desitin Arzneimittel, Eisai, GW, Medtronic, Novartis, Siemens and UCB.