First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study
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 retrosp...
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BMJ Publishing Group
2019-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/11/e030746.full |
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| author | Katja Menzler Peter Michael Mross Felix Rosenow Susanne Schubert-Bast Laurent Maximilian Willems Felix Zahnert Ilka Immisch Sven Fuest Felix von Podewils Rhina Kunz Martin Hirsch Tamara Mueller Justus Marquetand Yaroslav Winter Lisa Langenbruch Michal Cicanic Stefan Beyenburg Adam Strzelczyk Susanne Knake |
| author_facet | Katja Menzler Peter Michael Mross Felix Rosenow Susanne Schubert-Bast Laurent Maximilian Willems Felix Zahnert Ilka Immisch Sven Fuest Felix von Podewils Rhina Kunz Martin Hirsch Tamara Mueller Justus Marquetand Yaroslav Winter Lisa Langenbruch Michal Cicanic Stefan Beyenburg Adam Strzelczyk Susanne Knake |
| author_sort | Katja Menzler |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-0847375cebf042dabe390de60cdfd1bd |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-0847375cebf042dabe390de60cdfd1bd2025-08-20T02:05:35ZengBMJ Publishing GroupBMJ Open2044-60552019-11-0191110.1136/bmjopen-2019-030746First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre studyKatja Menzler0Peter Michael Mross1Felix Rosenow2Susanne Schubert-Bast3Laurent Maximilian Willems4Felix Zahnert5Ilka Immisch6Sven Fuest7Felix von Podewils8Rhina Kunz9Martin Hirsch10Tamara Mueller11Justus Marquetand12Yaroslav Winter13Lisa Langenbruch14Michal Cicanic15Stefan Beyenburg16Adam Strzelczyk17Susanne Knake181 Epilepsy Center Hessen, Department of Neurology, Philipps-University Marburg, Marburg, Germany1 Epilepsy Center Hessen, Department of Neurology, Philipps-University Marburg, Marburg, Germany5Epilepsy Center Frankfurt Rhine-Main, Frankfurt, Germany2 Epilepsy Center Frankfurt Rhine-Main, Department of Neurology, Center of Neurology and Neurosurgery, University Hospital, Goethe-University Frankfurt, Frankfurt am Main, Germany2 Epilepsy Center Frankfurt Rhine-Main, Department of Neurology, Center of Neurology and Neurosurgery, University Hospital, Goethe-University Frankfurt, Frankfurt am Main, Germany1 Epilepsy Center Hessen, Department of Neurology, Philipps-University Marburg, Marburg, Germany1 Epilepsy Center Hessen, Department of Neurology, Philipps-University Marburg, Marburg, Germany1 Epilepsy Center Hessen, Department of Neurology, Philipps-University Marburg, Marburg, Germany5 Epilepsy Center Greifswald and Department of Neurology, Ernst-Moritz-Arndt-University, Greifswald, Germany5 Epilepsy Center Greifswald and Department of Neurology, Ernst-Moritz-Arndt-University, Greifswald, Germany6 Epilepsy Center, Faculty of Medicine, University of Freiburg, Freiburg, GermanyDepartment of Neurology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany8 Epilepsy Center Tuebingen, Department of Neurology, University Hospital Tuebingen, Tuebingen, Germany9 Epilepsy Center Mainz, Department of Neurology, Johannes Gutenberg-University Mainz, Mainz, Germany10 Department of Neurology, University of Münster, Münster, Germany11 Sächsisches Epilepsiezentrum Radeberg gGmbH, Kleinwachau, Germany12 Hospital Center of Luxembourg, Luxembourg, Luxembourg5Epilepsy Center Frankfurt Rhine-Main, Frankfurt, Germany3 Department of Neurology, Epilepsy Centre Hessen, Philipps-University Marburg, Marburg, GermanyObjectives 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.https://bmjopen.bmj.com/content/9/11/e030746.full |
| spellingShingle | Katja Menzler Peter Michael Mross Felix Rosenow Susanne Schubert-Bast Laurent Maximilian Willems Felix Zahnert Ilka Immisch Sven Fuest Felix von Podewils Rhina Kunz Martin Hirsch Tamara Mueller Justus Marquetand Yaroslav Winter Lisa Langenbruch Michal Cicanic Stefan Beyenburg Adam Strzelczyk Susanne Knake First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study BMJ Open |
| title | First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study |
| title_full | First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study |
| title_fullStr | First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study |
| title_full_unstemmed | First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study |
| title_short | First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study |
| title_sort | first clinical postmarketing experiences in the treatment of epilepsies with brivaracetam a retrospective observational multicentre study |
| url | https://bmjopen.bmj.com/content/9/11/e030746.full |
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