Evidence map›Paper›PMID 34476770›Full record

Trial reportCNS drugs2021

Adjunctive Brivaracetam in Focal Epilepsy: Real-World Evidence from the BRIVAracetam add-on First Italian netwoRk STudy (BRIVAFIRST).

Simona Lattanzi, Laura Canafoglia, Maria Paola Canevini, Sara Casciato, Valentina Chiesa, Filippo Dainese, Giovanni De Maria, Giuseppe Didato, Giovanni Falcicchio, Martina Fanella and 16 more

Erratum issuedAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in CNS drugs, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 27 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 5 pooled it
–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

27 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Efficacy and safety of Brivaracetam as adjunctive therapy in pediatric epilepsy: A systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
    Pooled it
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  3. Brivaracetam add-on therapy for drug-resistant epilepsy.The Cochrane database of systematic reviews · 2022
    Pooled it
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  17. Review
  18. Brivaracetam use in clinical practice: a Delphi consensus on its role as first add-on therapy in focal epilepsy and beyond.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors.

Simona LattanziNeurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Via Conca 71, 60020, Ancona, Italy. alfierelattanzisimona@gmail.com.ORCID http://orcid.org/0000-0001-8748-0083
Laura CanafogliaDepartment of Epileptology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.
Maria Paola CaneviniEpilepsy Center, Child Neuropsychiatry Unit, AAST Santi Paolo Carlo, Milan, Italy.
Sara CasciatoIRCCS Neuromed, Pozzilli, Italy.
Valentina ChiesaEpilepsy Center, Child Neuropsychiatry Unit, AAST Santi Paolo Carlo, Milan, Italy.
Filippo DaineseEpilepsy Centre, Neurology Unit, Venice, Italy.
Giovanni De MariaClinical Neurophysiology Unit, Epilepsy Center, Spedali Civili, Brescia, Italy.
Giuseppe DidatoEpilepsy Unit, Fondazione IRCCS Istituto Neurologico "Carlo Besta", Milan, Italy.
Giovanni FalcicchioDepartment of Basic Medical Sciences, Neurosciences and Sense Organs, University Hospital of Bari "A. Moro", Bari, Italy.
Martina FanellaDepartment of Human Neurosciences, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.
Edoardo FerlazzoDepartment of Medical and Surgical Sciences, Magna Græcia University of Catanzaro, Catanzaro, Italy.
Giacomo FiscoDepartment of Human Neurosciences, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.
Massimo GangitanoDepartment of Biomedicine, Neuroscience, and advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.
Anna Teresa GiallonardoDepartment of Human Neurosciences, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.
Filippo Sean GiorgiDepartment of Translational Research on New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Angela La NeveDepartment of Basic Medical Sciences, Neurosciences and Sense Organs, University Hospital of Bari "A. Moro", Bari, Italy.
Oriano MecarelliDepartment of Human Neurosciences, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.
Elisa MontalentiEpilepsy Center, AOU Città della Salute e della Scienza di Torino, Turin, Italy.
Federico PiazzaDepartment of Neurosciences, Rita Levi Montalcini, University of Turin, Turin, Italy.
Patrizia PulitanoDepartment of Human Neurosciences, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.
Pier Paolo QuaratoIRCCS Neuromed, Pozzilli, Italy.
Federica RanzatoEpilepsy Center, UOC Neurology, AULSS, 8 Vicenza, Vicenza, Italy.
Eleonora RosatiDepartment Neurology 2, Careggi University Hospital, Florence, Italy.
Laura TassiC. Munari" Epilepsy Surgery Centre, Niguarda Hospital, Milan, Italy.
Carlo Di BonaventuraDepartment of Human Neurosciences, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.
BRIVAFIRST Group Membership

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn randomized controlled trials, add-on brivaracetam (BRV) reduced seizure frequency in patients with drug-resistant focal epilepsy. Studies performed in a naturalistic setting are a useful complement to characterize the drug profile.

objectiveThis multicentre study assessed the effectiveness and tolerability of adjunctive BRV in a large population of patients with focal epilepsy in the context of real-world clinical practice.

methodsThe BRIVAFIRST (BRIVAracetam add-on First Italian netwoRk STudy) was a retrospective, multicentre study including adult patients prescribed adjunctive BRV. Patients with focal epilepsy and 12-month follow-up were considered. Main outcomes included the rates of seizure-freedom, seizure response (≥ 50% reduction in baseline seizure frequency), and treatment discontinuation. The incidence of adverse events (AEs) was also considered. Analyses by levetiracetam (LEV) status and concomitant use of strong enzyme-inducing antiseizure medications (EiASMs) and sodium channel blockers (SCBs) were performed.

resultsA total of 1029 patients with a median age of 45 years (33-56) was included. At 12 months, 169 (16.4%) patients were seizure-free and 383 (37.2%) were seizure responders. The rate of seizure freedom was 22.3% in LEV-naive patients, 7.1% in patients with prior LEV use and discontinuation due to insufficient efficacy, and 31.2% in patients with prior LEV use and discontinuation due to AEs (p < 0.001); the corresponding values for ≥ 50% seizure frequency reduction were 47.9%, 29.7%, and 42.8% (p < 0.001). There were no statistically significant differences in seizure freedom and seizure response rates by use of strong EiASMs. The rates of seizure freedom (20.0% vs. 16.6%;  p = 0.341) and seizure response (39.7% vs. 26.9%; p = 0.006) were higher in patients receiving SCBs than those not receiving SCBs; 265 (25.8%) patients discontinued BRV. AEs were reported by 30.1% of patients, and were less common in patients treated with BRV and concomitant SCBs than those not treated with SCBs (28.9% vs. 39.8%; p = 0.017).

conclusionThe BRIVAFIRST provided real-world evidence on the effectiveness of BRV in patients with focal epilepsy irrespective of LEV history and concomitant ASMs, and suggested favourable therapeutic combinations.

Indexed as

AdultAnticonvulsantsChemotherapy, AdjuvantDrug Resistant EpilepsyEpilepsies, PartialFemaleHumansItalyLevetiracetamMaleMiddle AgedPyrrolidinonesRetrospective StudiesTreatment OutcomeAnticonvulsantsbrivaracetamLevetiracetamPyrrolidinones

Identifiers

PMID34476770
PMCPMC8642333

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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.