Evidence map›Paper›PMID 31690606›Full record

Observational studyBMJ open2019

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

Katja Menzler, Peter Michael Mross, Felix Rosenow, Susanne Schubert-Bast, Laurent Maximilian Willems, Felix Zahnert, Ilka Immisch, Sven Fuest, Felix von Podewils, Rhina Kunz and 9 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Observational
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Effectiveness and Safety of Brivaracetam in Children.Indian journal of pediatrics · 2021
    Article
  11. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Katja MenzlerEpilepsy Center Hessen, Department of Neurology, Philipps-University Marburg, Marburg, Germany hattemer@med.uni-marburg.de.ORCID 0000-0001-8289-480X
Peter Michael MrossEpilepsy Center Hessen, Department of Neurology, Philipps-University Marburg, Marburg, Germany.
Felix RosenowEpilepsy Center Hessen, Department of Neurology, Philipps-University Marburg, Marburg, Germany.
Susanne Schubert-BastEpilepsy Center Frankfurt Rhine-Main, Department of Neurology, Center of Neurology and Neurosurgery, University Hospital, Goethe-University Frankfurt, Frankfurt am Main, Germany.ORCID 0000-0003-1545-7364
Laurent Maximilian WillemsEpilepsy Center Frankfurt Rhine-Main, Department of Neurology, Center of Neurology and Neurosurgery, University Hospital, Goethe-University Frankfurt, Frankfurt am Main, Germany.ORCID 0000-0001-8226-1674
Felix ZahnertEpilepsy Center Hessen, Department of Neurology, Philipps-University Marburg, Marburg, Germany.
Ilka ImmischEpilepsy Center Hessen, Department of Neurology, Philipps-University Marburg, Marburg, Germany.
Sven FuestEpilepsy Center Hessen, Department of Neurology, Philipps-University Marburg, Marburg, Germany.
Felix von PodewilsEpilepsy Center Greifswald and Department of Neurology, Ernst-Moritz-Arndt-University, Greifswald, Germany.
Rhina KunzEpilepsy Center Greifswald and Department of Neurology, Ernst-Moritz-Arndt-University, Greifswald, Germany.
Martin HirschEpilepsy Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Tamara MuellerEpilepsy Center Erlangen, Department of Neurology, University of Erlangen, Erlangen, Germany.
Justus MarquetandEpilepsy Center Tuebingen, Department of Neurology, University Hospital Tuebingen, Tuebingen, Germany.
Yaroslav WinterEpilepsy Center Mainz, Department of Neurology, Johannes Gutenberg-University Mainz, Mainz, Germany.
Lisa LangenbruchDepartment of Neurology, University of Münster, Münster, Germany.
Michal CicanicSächsisches Epilepsiezentrum Radeberg gGmbH, Kleinwachau, Germany.
Stefan BeyenburgHospital Center of Luxembourg, Luxembourg, Luxembourg.
Adam StrzelczykEpilepsy Center Hessen, Department of Neurology, Philipps-University Marburg, Marburg, Germany.
Susanne KnakeEpilepsy Center Hessen, Department of Neurology, Philipps-University Marburg, Marburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesBrivaracetam (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.

designRetrospective, observational multicentre study.

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

participantsData 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 X

resultsOverall, 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.

conclusionsThe 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.

Indexed as

AdultAnticonvulsantsEpilepsyFemaleHumansMaleMiddle AgedProduct Surveillance, PostmarketingPyrrolidinonesRetrospective StudiesTreatment OutcomeYoung AdultAnticonvulsantsbrivaracetamPyrrolidinonesadverse eventsbrivaracetamefficacylevetiracetammonotherapytolerability

Identifiers

PMID31690606
PMCPMC6858140

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.