You are here

  • Home
  • Archive
  • Volume 9, Issue 11
  • First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study

Article Text

Article menu

Download PDFPDF

XML
Neurology
Original research
First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study
  1. Katja Menzler1,
  2. Peter Michael Mross1,
  3. Felix Rosenow1,2,3,
  4. Susanne Schubert-Bast2,3,4,
  5. Laurent Maximilian Willems2,
  6. Felix Zahnert1,
  7. Ilka Immisch1,
  8. Sven Fuest1,
  9. Felix von Podewils5,
  10. Rhina Kunz5,
  11. Martin Hirsch6,
  12. Tamara Mueller7,
  13. Justus Marquetand8,
  14. Yaroslav Winter9,
  15. Lisa Langenbruch10,
  16. Michal Cicanic11,
  17. Stefan Beyenburg12,
  18. Adam Strzelczyk1,2,3,
  19. Susanne Knake1,3
  1. 1 Epilepsy Center Hessen, Department of Neurology, Philipps-University Marburg, Marburg, Germany
  2. 2 Epilepsy Center Frankfurt Rhine-Main, Department of Neurology, Center of Neurology and Neurosurgery, University Hospital, Goethe-University Frankfurt, Frankfurt am Main, Germany
  3. 3 Center for Personalized Translational Epilepsy Research (CePTER)
  4. 4 Department of Child Neurology, Goethe-University Frankfurt am Main, Frankfurt am Main, Germany
  5. 5 Epilepsy Center Greifswald and Department of Neurology, Ernst-Moritz-Arndt-University, Greifswald, Germany
  6. 6 Epilepsy Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany
  7. 7 Epilepsy Center Erlangen, Department of Neurology, University of Erlangen, Erlangen, Germany
  8. 8 Epilepsy Center Tuebingen, Department of Neurology, University Hospital Tuebingen, Tuebingen, Germany
  9. 9 Epilepsy Center Mainz, Department of Neurology, Johannes Gutenberg-University Mainz, Mainz, Germany
  10. 10 Department of Neurology, University of Münster, Münster, Germany
  11. 11 Sächsisches Epilepsiezentrum Radeberg gGmbH, Kleinwachau, Germany
  12. 12 Hospital Center of Luxembourg, Luxembourg, Luxembourg
  1. Correspondence to Dr Katja Menzler; hattemer{at}med.uni-marburg.de

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.

  • brivaracetam
  • monotherapy
  • levetiracetam
  • adverse events
  • efficacy
  • tolerability

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-030746

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors KM: analysis and interpretation of the data, writing of the manuscript. PMM: acquisition of data, analysis and interpretation of the data. FR: acquisition of data, revision of the manuscript. SSB: acquisition of data, revision of the manuscript. LMW: acquisition of data, revision of the manuscript. FZ: acquisition of data, revision of the manuscript. Il: acquisition of data, revision of the manuscript. SF: acquisition of data, revision of the manuscript. FvP: acquisition of data, revision of the manuscript. RK: acquisition of data, revision of the manuscript. MH: acquisition of data, revision of the manuscript. TM: acquisition of data, revision of the manuscript. JM: acquisition of data, revision of the manuscript. YW: acquisition of data, revision of the manuscript. LL: acquisition of data, revision of the manuscript. MC: acquisition of data, revision of the manuscript. SB: acquisition of data, revision of the manuscript. AS: acquisition of data, revision of the manuscript. SK: study concept and design, analysis and interpretation of the data, revision of the manuscript.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • 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.

    • Patient consent for publication Not required.

    • Ethics approval The study was approved by local ethic committees.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon reasonable request.