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RESEARCH PRODUCT
First clinical postmarketing experiences in the treatment of epilepsies with brivaracetam: a retrospective observational multicentre study.
Justus MarquetandKatja MenzlerPeter Michael MrossRhina KunzFelix ZahnertStefan BeyenburgIlka ImmischLisa LangenbruchFelix RosenowSusanne Schubert-bastLaurent M. WillemsAdam StrzelczykMichal CicanicSusanne KnakeTamara M. MuellerFelix Von PodewilsMartin S. HirschYaroslav WinterSven Fuestsubject
AdultMalemedicine.medical_specialtylevetiracetamefficacyBrivaracetam03 medical and health sciencesEpilepsyYoung Adult0302 clinical medicineInternal medicinemedicineProduct Surveillance PostmarketingHumansIn patient030212 general & internal medicine1506tolerabilityAdverse effectRetrospective StudiesOriginal ResearchSeizure frequencyEpilepsybrivaracetambusiness.industryGeneral MedicineMiddle Agedmedicine.diseasePyrrolidinonesadverse eventsTreatment OutcomeTolerabilityNeurologymonotherapy1713Observational studyAnticonvulsantsFemaleLevetiracetambusiness030217 neurology & neurosurgerymedicine.drugdescription
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 measuresEfficacy regarding seizure frequency and tolerability of BRV were evaluated. Descriptive statistics complemented by X2 contingency tests and effect sizes were performed.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.
year | journal | country | edition | language |
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2019-11-07 | BMJ open |