Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy
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 a...
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Thieme Revinter Publicações
2021-06-01
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| Series: | Arquivos de Neuro-Psiquiatria |
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| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0004-282X2021000400290&tlng=en |
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| author | Maria Luiza Giraldes de MANREZA Tatiane Amaral PAN Eduardo Quinalha CARBONE Antonio Carlos Amedeo VATTIMO Renata HERRERA Douglas Costa MORAIS Rita Antonelli CARDOSO Glenda Corrêa Borges de LACERDA Katia LIN Frederico Nakane NAKANO Pedro André KOWACS André Luis Fernandes PALMINI Adélia Maria de Miranda Henriques SOUZA Stevin ZUNG Elza Márcia Targas YACUBIAN |
| author_facet | Maria Luiza Giraldes de MANREZA Tatiane Amaral PAN Eduardo Quinalha CARBONE Antonio Carlos Amedeo VATTIMO Renata HERRERA Douglas Costa MORAIS Rita Antonelli CARDOSO Glenda Corrêa Borges de LACERDA Katia LIN Frederico Nakane NAKANO Pedro André KOWACS André Luis Fernandes PALMINI Adélia Maria de Miranda Henriques SOUZA Stevin ZUNG Elza Márcia Targas YACUBIAN |
| author_sort | Maria Luiza Giraldes de MANREZA |
| collection | DOAJ |
| 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. |
| format | Article |
| id | doaj-art-617ed1b4fc8a47b98d957712c4af06a2 |
| institution | OA Journals |
| issn | 1678-4227 |
| language | English |
| publishDate | 2021-06-01 |
| publisher | Thieme Revinter Publicações |
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| series | Arquivos de Neuro-Psiquiatria |
| spelling | doaj-art-617ed1b4fc8a47b98d957712c4af06a22025-08-20T02:23:45ZengThieme Revinter PublicaçõesArquivos de Neuro-Psiquiatria1678-42272021-06-0179429029810.1590/0004-282x-anp-2020-0082Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsyMaria Luiza Giraldes de MANREZAhttps://orcid.org/0000-0003-0346-3417Tatiane Amaral PANhttps://orcid.org/0000-0001-8560-6762Eduardo Quinalha CARBONEhttps://orcid.org/0000-0002-2876-8156Antonio Carlos Amedeo VATTIMOhttps://orcid.org/0000-0002-1976-7434Renata HERRERAhttps://orcid.org/0000-0001-5137-086XDouglas Costa MORAIShttps://orcid.org/0000-0001-5160-2501Rita Antonelli CARDOSOhttps://orcid.org/0000-0003-3023-8936Glenda Corrêa Borges de LACERDAhttps://orcid.org/0000-0003-0776-0769Katia LINhttps://orcid.org/0000-0002-5401-7524Frederico Nakane NAKANOhttps://orcid.org/0000-0002-6860-3487Pedro André KOWACShttps://orcid.org/0000-0001-7770-7475André Luis Fernandes PALMINIhttps://orcid.org/0000-0002-4163-6924Adélia Maria de Miranda Henriques SOUZAhttps://orcid.org/0000-0002-5303-5528Stevin ZUNGhttps://orcid.org/0000-0002-8172-0928Elza Márcia Targas YACUBIANhttps://orcid.org/0000-0001-8367-0189ABSTRACT 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.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0004-282X2021000400290&tlng=enLevetiracetamRefractory EpilepsyFocal SeizuresAntiseizure MedicationsSeizures |
| spellingShingle | Maria Luiza Giraldes de MANREZA Tatiane Amaral PAN Eduardo Quinalha CARBONE Antonio Carlos Amedeo VATTIMO Renata HERRERA Douglas Costa MORAIS Rita Antonelli CARDOSO Glenda Corrêa Borges de LACERDA Katia LIN Frederico Nakane NAKANO Pedro André KOWACS André Luis Fernandes PALMINI Adélia Maria de Miranda Henriques SOUZA Stevin ZUNG Elza Márcia Targas YACUBIAN Efficacy and safety of levetiracetam as adjunctive therapy for refractory focal epilepsy Arquivos de Neuro-Psiquiatria Levetiracetam Refractory Epilepsy Focal Seizures Antiseizure Medications Seizures |
| title | 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_short | 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 |
| topic | Levetiracetam Refractory Epilepsy Focal Seizures Antiseizure Medications Seizures |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0004-282X2021000400290&tlng=en |
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