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

BMJ Open. 2019 Nov 4;9(11):e030746. doi: 10.1136/bmjopen-2019-030746.

Abstract

Objectives: 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.

Design: Retrospective, observational multicentre study.

Setting: We retrospectively collected clinical data of patients who received BRV in 10 epilepsy centres using a questionnaire that was answered by the reporting neurologist.

Participants: Data of 615 epilepsy patients treated with BRV were included in the study.

Primary and secondary outcome measures: Efficacy regarding seizure frequency and tolerability of BRV were evaluated. Descriptive statistics complemented by X2 contingency tests and effect sizes were performed.

Results: 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.

Conclusions: 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.

Keywords: adverse events; brivaracetam; efficacy; levetiracetam; monotherapy; tolerability.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Anticonvulsants / therapeutic use*
  • Epilepsy / drug therapy*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Product Surveillance, Postmarketing
  • Pyrrolidinones / therapeutic use*
  • Retrospective Studies
  • Treatment Outcome
  • Young Adult

Substances

  • Anticonvulsants
  • Pyrrolidinones
  • brivaracetam