BRIVA‐LIFE–A multicenter retrospective study of the long‐term use of brivaracetam in clinical practice

Objectives Evaluate long‐term effectiveness and tolerability of brivaracetam in clinical practice in patients with focal epilepsy. Materials and Methods This was a multicenter retrospective study. Patients aged ≥16 years were started on brivaracetam from November 2016 to June 2017 and followed over...

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Veröffentlicht in:Acta neurologica Scandinavica 2019-04, Vol.139 (4), p.360-368
Hauptverfasser: Villanueva, Vicente, López‐González, Francisco Javier, Mauri, José Angel, Rodriguez‐Uranga, Juan, Olivé‐Gadea, Marta, Montoya, Javier, Ruiz‐Giménez, Jesus, Zurita, Jorge, Abril, J, Toledo, M, Garcés, M, Gómez‐Ibáñez, A, Hampel, K, Rodriguez‐Osorio, X, Poza, JJ, Campos, D, Ojeda, J, Tortosa, D, Castro‐Vilanova, MD, Saiz‐Diaz, R, González de la Aleja, J, Castillo, A, de Toledo, M, Gago‐Veiga, AB, Piera, A, Crisostomo, J
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container_issue 4
container_start_page 360
container_title Acta neurologica Scandinavica
container_volume 139
creator Villanueva, Vicente
López‐González, Francisco Javier
Mauri, José Angel
Rodriguez‐Uranga, Juan
Olivé‐Gadea, Marta
Montoya, Javier
Ruiz‐Giménez, Jesus
Zurita, Jorge
Abril, J
Toledo, M
Garcés, M
Gómez‐Ibáñez, A
Hampel, K
Rodriguez‐Osorio, X
Poza, JJ
Campos, D
Ojeda, J
Tortosa, D
Castro‐Vilanova, MD
Saiz‐Diaz, R
González de la Aleja, J
Castillo, A
de Toledo, M
Gago‐Veiga, AB
Piera, A
Crisostomo, J
description Objectives Evaluate long‐term effectiveness and tolerability of brivaracetam in clinical practice in patients with focal epilepsy. Materials and Methods This was a multicenter retrospective study. Patients aged ≥16 years were started on brivaracetam from November 2016 to June 2017 and followed over 1 year. Data were obtained from medical records at 3, 6 and 12 months after treatment initiation for evaluation of safety‐ and seizure‐related outcomes. Results A total of 575 patients were included in analyses; most had been treated with ≥4 lifetime antiepileptic drugs. Target dosage was achieved by 30.6% of patients on the first day. Analysis of primary variables at 12 months revealed that mean reduction in seizure frequency was 36.0%, 39.7% of patients were ≥50% responders and 17.5% were seizure‐free. Seizure‐freedom was achieved by 37.5% of patients aged ≥65 years. Incidence of adverse events (AEs) and psychiatric AEs (PAEs) was 39.8% and 14.3%, respectively, and discontinuation due to these was 8.9% and 3.7%, respectively. Somnolence, irritability, and dizziness were the most frequently reported AEs. At baseline, 228 (39.7%) patients were being treated with levetiracetam; most switched to brivaracetam (dose ratio 1:10‐15). Among those who switched because of PAEs (n = 53), 9 (17%) reported PAEs on brivaracetam, and 3 (5.7%) discontinued because of PAEs. Tolerability was not highly affected among patients with learning disability or psychiatric comorbidity. Conclusions In a large population of patients with predominantly drug‐resistant epilepsy, brivaracetam was effective and well‐tolerated; no unexpected AEs occurred over 1 year, and the incidence of PAEs was lower compared with levetiracetam.
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Materials and Methods This was a multicenter retrospective study. Patients aged ≥16 years were started on brivaracetam from November 2016 to June 2017 and followed over 1 year. Data were obtained from medical records at 3, 6 and 12 months after treatment initiation for evaluation of safety‐ and seizure‐related outcomes. Results A total of 575 patients were included in analyses; most had been treated with ≥4 lifetime antiepileptic drugs. Target dosage was achieved by 30.6% of patients on the first day. Analysis of primary variables at 12 months revealed that mean reduction in seizure frequency was 36.0%, 39.7% of patients were ≥50% responders and 17.5% were seizure‐free. Seizure‐freedom was achieved by 37.5% of patients aged ≥65 years. Incidence of adverse events (AEs) and psychiatric AEs (PAEs) was 39.8% and 14.3%, respectively, and discontinuation due to these was 8.9% and 3.7%, respectively. Somnolence, irritability, and dizziness were the most frequently reported AEs. At baseline, 228 (39.7%) patients were being treated with levetiracetam; most switched to brivaracetam (dose ratio 1:10‐15). Among those who switched because of PAEs (n = 53), 9 (17%) reported PAEs on brivaracetam, and 3 (5.7%) discontinued because of PAEs. Tolerability was not highly affected among patients with learning disability or psychiatric comorbidity. Conclusions In a large population of patients with predominantly drug‐resistant epilepsy, brivaracetam was effective and well‐tolerated; no unexpected AEs occurred over 1 year, and the incidence of PAEs was lower compared with levetiracetam.</description><identifier>ISSN: 0001-6314</identifier><identifier>EISSN: 1600-0404</identifier><identifier>DOI: 10.1111/ane.13059</identifier><identifier>PMID: 30506559</identifier><language>eng</language><publisher>Denmark: Hindawi Limited</publisher><subject>Adolescent ; Adult ; Aged ; Anticonvulsants - therapeutic use ; Antiepileptic agents ; Clinical medicine ; Convulsions &amp; seizures ; Dosage ; Drug Resistant Epilepsy - drug therapy ; Epilepsies, Partial - drug therapy ; Epilepsy ; Etiracetam ; Female ; Humans ; Male ; Medical records ; Middle Aged ; Patients ; Pyrrolidinones - therapeutic use ; Retrospective Studies ; Seizures ; Seizures - prevention &amp; control ; Treatment Outcome ; Young Adult</subject><ispartof>Acta neurologica Scandinavica, 2019-04, Vol.139 (4), p.360-368</ispartof><rights>2018 John Wiley &amp; Sons A/S. Published by John Wiley &amp; Sons Ltd</rights><rights>2018 John Wiley &amp; Sons A/S. Published by John Wiley &amp; Sons Ltd.</rights><rights>Copyright © 2019 John Wiley &amp; Sons A/S. 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Materials and Methods This was a multicenter retrospective study. Patients aged ≥16 years were started on brivaracetam from November 2016 to June 2017 and followed over 1 year. Data were obtained from medical records at 3, 6 and 12 months after treatment initiation for evaluation of safety‐ and seizure‐related outcomes. Results A total of 575 patients were included in analyses; most had been treated with ≥4 lifetime antiepileptic drugs. Target dosage was achieved by 30.6% of patients on the first day. Analysis of primary variables at 12 months revealed that mean reduction in seizure frequency was 36.0%, 39.7% of patients were ≥50% responders and 17.5% were seizure‐free. Seizure‐freedom was achieved by 37.5% of patients aged ≥65 years. Incidence of adverse events (AEs) and psychiatric AEs (PAEs) was 39.8% and 14.3%, respectively, and discontinuation due to these was 8.9% and 3.7%, respectively. Somnolence, irritability, and dizziness were the most frequently reported AEs. At baseline, 228 (39.7%) patients were being treated with levetiracetam; most switched to brivaracetam (dose ratio 1:10‐15). Among those who switched because of PAEs (n = 53), 9 (17%) reported PAEs on brivaracetam, and 3 (5.7%) discontinued because of PAEs. Tolerability was not highly affected among patients with learning disability or psychiatric comorbidity. Conclusions In a large population of patients with predominantly drug‐resistant epilepsy, brivaracetam was effective and well‐tolerated; no unexpected AEs occurred over 1 year, and the incidence of PAEs was lower compared with levetiracetam.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Anticonvulsants - therapeutic use</subject><subject>Antiepileptic agents</subject><subject>Clinical medicine</subject><subject>Convulsions &amp; seizures</subject><subject>Dosage</subject><subject>Drug Resistant Epilepsy - drug therapy</subject><subject>Epilepsies, Partial - drug therapy</subject><subject>Epilepsy</subject><subject>Etiracetam</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Medical records</subject><subject>Middle Aged</subject><subject>Patients</subject><subject>Pyrrolidinones - therapeutic use</subject><subject>Retrospective Studies</subject><subject>Seizures</subject><subject>Seizures - prevention &amp; 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López‐González, Francisco Javier ; Mauri, José Angel ; Rodriguez‐Uranga, Juan ; Olivé‐Gadea, Marta ; Montoya, Javier ; Ruiz‐Giménez, Jesus ; Zurita, Jorge ; Abril, J ; Toledo, M ; Garcés, M ; Gómez‐Ibáñez, A ; Hampel, K ; Rodriguez‐Osorio, X ; Poza, JJ ; Campos, D ; Ojeda, J ; Tortosa, D ; Castro‐Vilanova, MD ; Saiz‐Diaz, R ; González de la Aleja, J ; Castillo, A ; de Toledo, M ; Gago‐Veiga, AB ; Piera, A ; Crisostomo, J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3889-1837058f3faa2993aee8c7ec89c49f1d518ebf1718d8aa7e4b530db73ccd91683</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Anticonvulsants - therapeutic use</topic><topic>Antiepileptic agents</topic><topic>Clinical medicine</topic><topic>Convulsions &amp; seizures</topic><topic>Dosage</topic><topic>Drug Resistant Epilepsy - drug therapy</topic><topic>Epilepsies, Partial - drug therapy</topic><topic>Epilepsy</topic><topic>Etiracetam</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Medical records</topic><topic>Middle Aged</topic><topic>Patients</topic><topic>Pyrrolidinones - therapeutic use</topic><topic>Retrospective Studies</topic><topic>Seizures</topic><topic>Seizures - prevention &amp; control</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Villanueva, Vicente</creatorcontrib><creatorcontrib>López‐González, Francisco Javier</creatorcontrib><creatorcontrib>Mauri, José Angel</creatorcontrib><creatorcontrib>Rodriguez‐Uranga, Juan</creatorcontrib><creatorcontrib>Olivé‐Gadea, Marta</creatorcontrib><creatorcontrib>Montoya, Javier</creatorcontrib><creatorcontrib>Ruiz‐Giménez, Jesus</creatorcontrib><creatorcontrib>Zurita, Jorge</creatorcontrib><creatorcontrib>Abril, J</creatorcontrib><creatorcontrib>Toledo, M</creatorcontrib><creatorcontrib>Garcés, M</creatorcontrib><creatorcontrib>Gómez‐Ibáñez, A</creatorcontrib><creatorcontrib>Hampel, K</creatorcontrib><creatorcontrib>Rodriguez‐Osorio, X</creatorcontrib><creatorcontrib>Poza, JJ</creatorcontrib><creatorcontrib>Campos, D</creatorcontrib><creatorcontrib>Ojeda, J</creatorcontrib><creatorcontrib>Tortosa, D</creatorcontrib><creatorcontrib>Castro‐Vilanova, MD</creatorcontrib><creatorcontrib>Saiz‐Diaz, R</creatorcontrib><creatorcontrib>González de la Aleja, J</creatorcontrib><creatorcontrib>Castillo, A</creatorcontrib><creatorcontrib>de Toledo, M</creatorcontrib><creatorcontrib>Gago‐Veiga, AB</creatorcontrib><creatorcontrib>Piera, A</creatorcontrib><creatorcontrib>Crisostomo, J</creatorcontrib><creatorcontrib>BRIVA-LIFE study group</creatorcontrib><creatorcontrib>the BRIVA-LIFE study group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health &amp; 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Materials and Methods This was a multicenter retrospective study. Patients aged ≥16 years were started on brivaracetam from November 2016 to June 2017 and followed over 1 year. Data were obtained from medical records at 3, 6 and 12 months after treatment initiation for evaluation of safety‐ and seizure‐related outcomes. Results A total of 575 patients were included in analyses; most had been treated with ≥4 lifetime antiepileptic drugs. Target dosage was achieved by 30.6% of patients on the first day. Analysis of primary variables at 12 months revealed that mean reduction in seizure frequency was 36.0%, 39.7% of patients were ≥50% responders and 17.5% were seizure‐free. Seizure‐freedom was achieved by 37.5% of patients aged ≥65 years. Incidence of adverse events (AEs) and psychiatric AEs (PAEs) was 39.8% and 14.3%, respectively, and discontinuation due to these was 8.9% and 3.7%, respectively. Somnolence, irritability, and dizziness were the most frequently reported AEs. At baseline, 228 (39.7%) patients were being treated with levetiracetam; most switched to brivaracetam (dose ratio 1:10‐15). Among those who switched because of PAEs (n = 53), 9 (17%) reported PAEs on brivaracetam, and 3 (5.7%) discontinued because of PAEs. Tolerability was not highly affected among patients with learning disability or psychiatric comorbidity. Conclusions In a large population of patients with predominantly drug‐resistant epilepsy, brivaracetam was effective and well‐tolerated; no unexpected AEs occurred over 1 year, and the incidence of PAEs was lower compared with levetiracetam.</abstract><cop>Denmark</cop><pub>Hindawi Limited</pub><pmid>30506559</pmid><doi>10.1111/ane.13059</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-2080-8042</orcidid><oa>free_for_read</oa></addata></record>
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source MEDLINE; Wiley Online Library Journals Frontfile Complete
subjects Adolescent
Adult
Aged
Anticonvulsants - therapeutic use
Antiepileptic agents
Clinical medicine
Convulsions & seizures
Dosage
Drug Resistant Epilepsy - drug therapy
Epilepsies, Partial - drug therapy
Epilepsy
Etiracetam
Female
Humans
Male
Medical records
Middle Aged
Patients
Pyrrolidinones - therapeutic use
Retrospective Studies
Seizures
Seizures - prevention & control
Treatment Outcome
Young Adult
title BRIVA‐LIFE–A multicenter retrospective study of the long‐term use of brivaracetam in clinical practice
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