Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy
Autor(a) principal: | |
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Data de Publicação: | 2021 |
Outros Autores: | , , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Arquivos de neuro-psiquiatria (Online) |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0004-282X2021000400290 |
Resumo: | ABSTRACT Background: Epilepsy affects about 50 million people worldwide and around 30% of these patients have refractory epilepsy, with potential consequences regarding quality of life, morbidity and premature mortality. Objective: The aim of treatment with antiseizure medications (ASMs) is to allow patients to remain without seizures, with good tolerability. Levetiracetam is a broad-spectrum ASM with a unique mechanism of action that differs it from other ASMs. It has been shown to be effective and safe for treating adults and children with epilepsy. Methods: This was a phase III, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of levetiracetam in children and adults (4-65 years) as an adjuvant treatment for focal-onset seizures. It was conducted among 114 patients undergoing treatment with up to three ASMs. The primary efficacy analysis was based on the proportion of patients who achieved a reduction of ≥ 50% in the mean number of focal seizures per week, over a 16-week treatment period. The patients were randomized to receive placebo or levetiracetam, titrated every two weeks from 20 mg/kg/day or 1,000 mg/day up to 60 mg/kg/day or 3,000 mg/day. Results: Levetiracetam was significantly superior to placebo (p = 0.0031); 38.7% of the participants in the levetiracetam group and 14.3% in the control group shows reductions in focal seizures. Levetiracetam was seen to have a favorable safety profile and an adverse event rate similar to that of placebo. Conclusion: Corroborating the results in the literature, levetiracetam was shown to be effective and safe for children and adults with refractory focal-onset epilepsy. |
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Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsyLevetiracetamRefractory EpilepsyFocal SeizuresAntiseizure MedicationsSeizuresABSTRACT Background: Epilepsy affects about 50 million people worldwide and around 30% of these patients have refractory epilepsy, with potential consequences regarding quality of life, morbidity and premature mortality. Objective: The aim of treatment with antiseizure medications (ASMs) is to allow patients to remain without seizures, with good tolerability. Levetiracetam is a broad-spectrum ASM with a unique mechanism of action that differs it from other ASMs. It has been shown to be effective and safe for treating adults and children with epilepsy. Methods: This was a phase III, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of levetiracetam in children and adults (4-65 years) as an adjuvant treatment for focal-onset seizures. It was conducted among 114 patients undergoing treatment with up to three ASMs. The primary efficacy analysis was based on the proportion of patients who achieved a reduction of ≥ 50% in the mean number of focal seizures per week, over a 16-week treatment period. The patients were randomized to receive placebo or levetiracetam, titrated every two weeks from 20 mg/kg/day or 1,000 mg/day up to 60 mg/kg/day or 3,000 mg/day. Results: Levetiracetam was significantly superior to placebo (p = 0.0031); 38.7% of the participants in the levetiracetam group and 14.3% in the control group shows reductions in focal seizures. Levetiracetam was seen to have a favorable safety profile and an adverse event rate similar to that of placebo. Conclusion: Corroborating the results in the literature, levetiracetam was shown to be effective and safe for children and adults with refractory focal-onset epilepsy.Academia Brasileira de Neurologia - ABNEURO2021-04-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0004-282X2021000400290Arquivos de Neuro-Psiquiatria v.79 n.4 2021reponame:Arquivos de neuro-psiquiatria (Online)instname:Academia Brasileira de Neurologiainstacron:ABNEURO10.1590/0004-282x-anp-2020-0082info:eu-repo/semantics/openAccessMANREZA,Maria Luiza Giraldes dePAN,Tatiane AmaralCARBONE,Eduardo QuinalhaVATTIMO,Antonio Carlos AmedeoHERRERA,RenataMORAIS,Douglas CostaCARDOSO,Rita AntonelliLACERDA,Glenda Corrêa Borges deLIN,KatiaNAKANO,Frederico NakaneKOWACS,Pedro AndréPALMINI,André Luis FernandesSOUZA,Adélia Maria de Miranda HenriquesZUNG,StevinYACUBIAN,Elza Márcia Targaseng2021-06-07T00:00:00Zoai:scielo:S0004-282X2021000400290Revistahttp://www.scielo.br/anphttps://old.scielo.br/oai/scielo-oai.php||revista.arquivos@abneuro.org1678-42270004-282Xopendoar:2021-06-07T00:00Arquivos de neuro-psiquiatria (Online) - Academia Brasileira de Neurologiafalse |
dc.title.none.fl_str_mv |
Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy |
title |
Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy |
spellingShingle |
Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy MANREZA,Maria Luiza Giraldes de Levetiracetam Refractory Epilepsy Focal Seizures Antiseizure Medications Seizures |
title_short |
Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy |
title_full |
Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy |
title_fullStr |
Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy |
title_full_unstemmed |
Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy |
title_sort |
Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy |
author |
MANREZA,Maria Luiza Giraldes de |
author_facet |
MANREZA,Maria Luiza Giraldes de PAN,Tatiane Amaral CARBONE,Eduardo Quinalha VATTIMO,Antonio Carlos Amedeo HERRERA,Renata MORAIS,Douglas Costa CARDOSO,Rita Antonelli LACERDA,Glenda Corrêa Borges de LIN,Katia NAKANO,Frederico Nakane KOWACS,Pedro André PALMINI,André Luis Fernandes SOUZA,Adélia Maria de Miranda Henriques ZUNG,Stevin YACUBIAN,Elza Márcia Targas |
author_role |
author |
author2 |
PAN,Tatiane Amaral CARBONE,Eduardo Quinalha VATTIMO,Antonio Carlos Amedeo HERRERA,Renata MORAIS,Douglas Costa CARDOSO,Rita Antonelli LACERDA,Glenda Corrêa Borges de LIN,Katia NAKANO,Frederico Nakane KOWACS,Pedro André PALMINI,André Luis Fernandes SOUZA,Adélia Maria de Miranda Henriques ZUNG,Stevin YACUBIAN,Elza Márcia Targas |
author2_role |
author author author author author author author author author author author author author author |
dc.contributor.author.fl_str_mv |
MANREZA,Maria Luiza Giraldes de PAN,Tatiane Amaral CARBONE,Eduardo Quinalha VATTIMO,Antonio Carlos Amedeo HERRERA,Renata MORAIS,Douglas Costa CARDOSO,Rita Antonelli LACERDA,Glenda Corrêa Borges de LIN,Katia NAKANO,Frederico Nakane KOWACS,Pedro André PALMINI,André Luis Fernandes SOUZA,Adélia Maria de Miranda Henriques ZUNG,Stevin YACUBIAN,Elza Márcia Targas |
dc.subject.por.fl_str_mv |
Levetiracetam Refractory Epilepsy Focal Seizures Antiseizure Medications Seizures |
topic |
Levetiracetam Refractory Epilepsy Focal Seizures Antiseizure Medications Seizures |
description |
ABSTRACT Background: Epilepsy affects about 50 million people worldwide and around 30% of these patients have refractory epilepsy, with potential consequences regarding quality of life, morbidity and premature mortality. Objective: The aim of treatment with antiseizure medications (ASMs) is to allow patients to remain without seizures, with good tolerability. Levetiracetam is a broad-spectrum ASM with a unique mechanism of action that differs it from other ASMs. It has been shown to be effective and safe for treating adults and children with epilepsy. Methods: This was a phase III, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of levetiracetam in children and adults (4-65 years) as an adjuvant treatment for focal-onset seizures. It was conducted among 114 patients undergoing treatment with up to three ASMs. The primary efficacy analysis was based on the proportion of patients who achieved a reduction of ≥ 50% in the mean number of focal seizures per week, over a 16-week treatment period. The patients were randomized to receive placebo or levetiracetam, titrated every two weeks from 20 mg/kg/day or 1,000 mg/day up to 60 mg/kg/day or 3,000 mg/day. Results: Levetiracetam was significantly superior to placebo (p = 0.0031); 38.7% of the participants in the levetiracetam group and 14.3% in the control group shows reductions in focal seizures. Levetiracetam was seen to have a favorable safety profile and an adverse event rate similar to that of placebo. Conclusion: Corroborating the results in the literature, levetiracetam was shown to be effective and safe for children and adults with refractory focal-onset epilepsy. |
publishDate |
2021 |
dc.date.none.fl_str_mv |
2021-04-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0004-282X2021000400290 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0004-282X2021000400290 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.1590/0004-282x-anp-2020-0082 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
dc.publisher.none.fl_str_mv |
Academia Brasileira de Neurologia - ABNEURO |
publisher.none.fl_str_mv |
Academia Brasileira de Neurologia - ABNEURO |
dc.source.none.fl_str_mv |
Arquivos de Neuro-Psiquiatria v.79 n.4 2021 reponame:Arquivos de neuro-psiquiatria (Online) instname:Academia Brasileira de Neurologia instacron:ABNEURO |
instname_str |
Academia Brasileira de Neurologia |
instacron_str |
ABNEURO |
institution |
ABNEURO |
reponame_str |
Arquivos de neuro-psiquiatria (Online) |
collection |
Arquivos de neuro-psiquiatria (Online) |
repository.name.fl_str_mv |
Arquivos de neuro-psiquiatria (Online) - Academia Brasileira de Neurologia |
repository.mail.fl_str_mv |
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