Evidence map›Paper›PMID 39470722›Full record

Observational studyEpilepsia open2024

BRIVA-ONE study: 12-month outcomes of brivaracetam monotherapy in clinical practice.

Vicente Villanueva, Esther González Villar, Alejandro Fernandez-Cabrera, Jorge Zurita, Francisco J Lopez-Gonzalez, Xiana Rodríguez-Osorio, Beatriz Parejo-Carbonell, José C Estevez, Blanca Mercedes-Alvarez, Joaquín Ojeda and 21 more

Abstract readObservational StudyMulticenter Study
In one paragraph

Observational study in Epilepsia open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Observational
  6. Article
  7. Review
  8. Observational
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

31 authors.

Vicente VillanuevaHospital Universitario y Politécnic La Fe. Member of ERN EPICARE, Valencia, Spain.
Esther González VillarHospital Universitario y IIS Fundacion Jiménez Diaz, Madrid, Spain.
Alejandro Fernandez-CabreraHospital Universitario Lucus Augusti, Lugo, Spain.
Jorge ZuritaHospital Universitario Infanta Leonor, Madrid, Spain.
Francisco J Lopez-GonzalezComplejo Hospitalario Universitario Santiago, Santiago de Compostela, Spain.
Xiana Rodríguez-OsorioComplejo Hospitalario Universitario Santiago, Santiago de Compostela, Spain.
Beatriz Parejo-CarbonellHospital Clinico Universitario, Madrid, Spain.
José C EstevezHospital Universitario Reina Sofia, Cordoba, Spain.
Blanca Mercedes-AlvarezHospital Universitario Gregorio Marañón, Madrid, Spain.
Joaquín OjedaHospital Universitario Infanta Sofia, Madrid, Spain.ORCID https://orcid.org/0000-0002-1117-5389
Marta Rubio-RoyParc Taulí Hospital Universitari, Sabadell, Spain.
Alexandre Garcia-EscriváHospital Denia, Denia, Spain.
Asier Gómez-IbáñezClinica Universidad de Navarra, Madrid, Spain.
Javier Martinez-PolesHospital Universitario Rey Juan Carlos, Madrid, Spain.ORCID https://orcid.org/0000-0002-0866-9476
Paula Martinez-AgredanoHospital Universitario Reina Sofia, Cordoba, Spain.
Raquel CalleHospital Universitario Clinico San Cecilio, Granada, Spain.
Alba Sierra-MarcosHospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Ana M GonzalezHospital General La Mancha Centro, Alcazar de San Juan, Spain.
José D HerreraHospital Universitario Virgen de Las Nieves, Granada, Spain.
Juan Rodriguez-UrangaCentro Neurologia Avanzada, Sevilla, Spain.ORCID https://orcid.org/0009-0007-5354-1256
Beatriz CabezasComplejo Asistencial Universitario Leon, Leon, Spain.
Emilio MartinezHospital Vinaroz, Vinaroz, Spain.
Julia RenauHospital General Universitario, Castellon, Spain.
María de ToledoHospital Universitario La Princesa, Madrid, Spain.
Kevin G HampelHospital Universitario y Politécnic La Fe. Member of ERN EPICARE, Valencia, Spain.ORCID https://orcid.org/0000-0003-3582-060X
Cristina AlarcónHospital Gomez Ulla, Madrid, Spain.
María Inés BarcelóHospital Universitario Son Espases, Palma de Mallorca, Spain.
Angela MonterdeHospital Universitari Joan XXIII, Tarragona, Spain.
Lidia B LaraHospital Universitari Joan XXIII, Tarragona, Spain.
Gemma SansaHospital Parc Tauli, Sabadell, Spain.
José M SerratosaHospital Universitario y IIS Fundacion Jiménez Diaz, Madrid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study investigated the effectiveness and tolerability of brivaracetam (BRV) monotherapy in a large series of patients with epilepsy.

methodThis was a multicenter, retrospective, observational, non-interventional study in 24 hospitals across Spain. Patients aged ≥18 years who started on BRV monotherapy, either as first-line or following conversion, at least 1 year before database closure were included. Patients were evaluated at baseline and at 3, 6 and 12 months after initiation of BRV monotherapy, in accordance with usual clinical practice at these centers. Data were collected retrospectively from patients' individual charts by participating physicians. The primary effectiveness and safety endpoints were the percentage of seizure-free patients 1 year after initiation of BRV monotherapy and the proportion of patients reporting adverse events (AEs) over the complete follow-up period. Retention rates and subpopulation analysis (levetiracetam switchers, elderly and different etiologies) were also investigated.

resultsA total of 276 patients were included (48 with BRV as first-line monotherapy and 228 who converted to BRV monotherapy). The overall retention rate in monotherapy at 12 months was 89.9% (87.5% for first-line monotherapy group; 90.4% for conversion-to-monotherapy group). Seizure-freedom rates at 12 months were 77.8% (75% for first-line monotherapy group; 78.4% for conversion-to-monotherapy group). AEs occurred in 39.5% of patients at 12 months (35.4% for first-line monotherapy group; 40.4% for conversion-to-monotherapy group). Most AEs were mild-to-moderate. The most frequent AEs were irritability (12.3%) and dizziness (10.1%). The most frequent AEs leading to BRV withdrawal were dizziness (1.8%) and memory problems (1.4%). Similar outcomes in terms of effectiveness and tolerability of BRV monotherapy were observed in patients switching from levetiracetam, those with different epilepsy etiologies, and elderly patients. SIGNIFICANCE: BRV was effective and well tolerated both as first-line monotherapy and following conversion to monotherapy in a real-world setting of patients with epilepsy. PLAIN LANGUAGE SUMMARY: The goal of the medical treatment of epilepsy is to ensure best possible patient quality of life, by maximizing seizure control and minimizing medication toxicity. Brivaracetam (BRV) is a new-generation epilepsy treatment that is well tolerated by patients. In our study, monotherapy with BRV reduced seizures in patients who had not received other treatments and in patients who switched from a previous treatment to BRV monotherapy. BRV was well tolerated and also effective in sensitive patients (i.e., the elderly and those who had epilepsy caused by a brain tumor or a brain injury).

Indexed as

AnticonvulsantsEpilepsyPyrrolidinonesAdultAgedFemaleHumansMaleMiddle AgedRetrospective StudiesSpainTreatment OutcomeYoung AdultAnticonvulsantsbrivaracetamPyrrolidinonesanti‐seizure medicationepilepsymonotherapy

Identifiers

PMID39470722
PMCPMC11633701

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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.