Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis : an open-label, randomized, and controlled pilot trial in Brazil
Autor(a) principal: | |
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Data de Publicação: | 2017 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UnB |
Texto Completo: | http://repositorio.unb.br/handle/10482/30574 http://dx.doi.org/10.1590/0037-8682-0455-2016 |
Resumo: | Introduction: despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. Methods: this was a randomized, open-label, 2-arm and controlled pilot clinical trial. Treatment naïve children and adolescents with VL without signs of severe illness were treated with N-methylglucamine antimoniate (20mg/kg/day for 20 days) or amphotericin B deoxycholate (1 mg/kg/day for 14 days). All patients were diagnosed with positive direct examination and/or positive PCR for Leishmania spp. performed in bone marrow samples. The primary efficacy end-point was VL cure determined after 180 days of completion of treatment. The analysis was performed using intention-to-treat (ITT) and per protocol (PP) analyses. Results: in total, 101 volunteers were assessed. Efficacy was similar for both groups. The antimonial (n=51) and amphotericin B groups (n=50) had a cure rate of 94.1% and 100%, and 94% and 97.9% according to ITT and PP analyses, respectively. All patients reported adverse events (AE). Serious AE incidence was similar in both groups. Five individuals were excluded from the study because of severe adverse events. Conclusions: N-methylglucamine antimoniate and amphotericin B deoxycholate have similar efficacy and adverse events rate in pediatric patients with VL. |
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Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis : an open-label, randomized, and controlled pilot trial in BrazilLeishmaniose visceral - criançasIntroduction: despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. Methods: this was a randomized, open-label, 2-arm and controlled pilot clinical trial. Treatment naïve children and adolescents with VL without signs of severe illness were treated with N-methylglucamine antimoniate (20mg/kg/day for 20 days) or amphotericin B deoxycholate (1 mg/kg/day for 14 days). All patients were diagnosed with positive direct examination and/or positive PCR for Leishmania spp. performed in bone marrow samples. The primary efficacy end-point was VL cure determined after 180 days of completion of treatment. The analysis was performed using intention-to-treat (ITT) and per protocol (PP) analyses. Results: in total, 101 volunteers were assessed. Efficacy was similar for both groups. The antimonial (n=51) and amphotericin B groups (n=50) had a cure rate of 94.1% and 100%, and 94% and 97.9% according to ITT and PP analyses, respectively. All patients reported adverse events (AE). Serious AE incidence was similar in both groups. Five individuals were excluded from the study because of severe adverse events. Conclusions: N-methylglucamine antimoniate and amphotericin B deoxycholate have similar efficacy and adverse events rate in pediatric patients with VL.Faculdade de Medicina (FMD)Sociedade Brasileira de Medicina Tropical - SBMT2018-01-04T19:13:13Z2018-01-04T19:13:13Z2017-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfBORGES, Myrlena Mescouto et al. Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil. Revista da Sociedade Brasileira de Medicina Tropical, Uberaba, v. 50, n. 1, p. 67-74, jan./fev. 2017. Disponível em: <http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822017000100067&lng=en&nrm=iso>. Acesso em: 22 fev. 2018. doi: http://dx.doi.org/10.1590/0037-8682-0455-2016.http://repositorio.unb.br/handle/10482/30574http://dx.doi.org/10.1590/0037-8682-0455-2016Revista da Sociedade Brasileira de Medicina Tropical - This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0). Fonte: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822017000100067&lng=en&nrm=iso. Acesso em: 22 fev. 2018.info:eu-repo/semantics/openAccessBorges, Myrlena MescoutoPranchevicius, Maria Cristina da SilvaNoronha, Elza FerreiraRomero, Gustavo Adolfo SierraCarranza Tamayo, César Omarengreponame:Repositório Institucional da UnBinstname:Universidade de Brasília (UnB)instacron:UNB2023-08-25T02:17:32Zoai:repositorio.unb.br:10482/30574Repositório InstitucionalPUBhttps://repositorio.unb.br/oai/requestrepositorio@unb.bropendoar:2023-08-25T02:17:32Repositório Institucional da UnB - Universidade de Brasília (UnB)false |
dc.title.none.fl_str_mv |
Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis : an open-label, randomized, and controlled pilot trial in Brazil |
title |
Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis : an open-label, randomized, and controlled pilot trial in Brazil |
spellingShingle |
Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis : an open-label, randomized, and controlled pilot trial in Brazil Borges, Myrlena Mescouto Leishmaniose visceral - crianças |
title_short |
Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis : an open-label, randomized, and controlled pilot trial in Brazil |
title_full |
Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis : an open-label, randomized, and controlled pilot trial in Brazil |
title_fullStr |
Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis : an open-label, randomized, and controlled pilot trial in Brazil |
title_full_unstemmed |
Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis : an open-label, randomized, and controlled pilot trial in Brazil |
title_sort |
Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis : an open-label, randomized, and controlled pilot trial in Brazil |
author |
Borges, Myrlena Mescouto |
author_facet |
Borges, Myrlena Mescouto Pranchevicius, Maria Cristina da Silva Noronha, Elza Ferreira Romero, Gustavo Adolfo Sierra Carranza Tamayo, César Omar |
author_role |
author |
author2 |
Pranchevicius, Maria Cristina da Silva Noronha, Elza Ferreira Romero, Gustavo Adolfo Sierra Carranza Tamayo, César Omar |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Borges, Myrlena Mescouto Pranchevicius, Maria Cristina da Silva Noronha, Elza Ferreira Romero, Gustavo Adolfo Sierra Carranza Tamayo, César Omar |
dc.subject.por.fl_str_mv |
Leishmaniose visceral - crianças |
topic |
Leishmaniose visceral - crianças |
description |
Introduction: despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. Methods: this was a randomized, open-label, 2-arm and controlled pilot clinical trial. Treatment naïve children and adolescents with VL without signs of severe illness were treated with N-methylglucamine antimoniate (20mg/kg/day for 20 days) or amphotericin B deoxycholate (1 mg/kg/day for 14 days). All patients were diagnosed with positive direct examination and/or positive PCR for Leishmania spp. performed in bone marrow samples. The primary efficacy end-point was VL cure determined after 180 days of completion of treatment. The analysis was performed using intention-to-treat (ITT) and per protocol (PP) analyses. Results: in total, 101 volunteers were assessed. Efficacy was similar for both groups. The antimonial (n=51) and amphotericin B groups (n=50) had a cure rate of 94.1% and 100%, and 94% and 97.9% according to ITT and PP analyses, respectively. All patients reported adverse events (AE). Serious AE incidence was similar in both groups. Five individuals were excluded from the study because of severe adverse events. Conclusions: N-methylglucamine antimoniate and amphotericin B deoxycholate have similar efficacy and adverse events rate in pediatric patients with VL. |
publishDate |
2017 |
dc.date.none.fl_str_mv |
2017-01 2018-01-04T19:13:13Z 2018-01-04T19:13:13Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
BORGES, Myrlena Mescouto et al. Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil. Revista da Sociedade Brasileira de Medicina Tropical, Uberaba, v. 50, n. 1, p. 67-74, jan./fev. 2017. Disponível em: <http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822017000100067&lng=en&nrm=iso>. Acesso em: 22 fev. 2018. doi: http://dx.doi.org/10.1590/0037-8682-0455-2016. http://repositorio.unb.br/handle/10482/30574 http://dx.doi.org/10.1590/0037-8682-0455-2016 |
identifier_str_mv |
BORGES, Myrlena Mescouto et al. Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil. Revista da Sociedade Brasileira de Medicina Tropical, Uberaba, v. 50, n. 1, p. 67-74, jan./fev. 2017. Disponível em: <http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822017000100067&lng=en&nrm=iso>. Acesso em: 22 fev. 2018. doi: http://dx.doi.org/10.1590/0037-8682-0455-2016. |
url |
http://repositorio.unb.br/handle/10482/30574 http://dx.doi.org/10.1590/0037-8682-0455-2016 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Sociedade Brasileira de Medicina Tropical - SBMT |
publisher.none.fl_str_mv |
Sociedade Brasileira de Medicina Tropical - SBMT |
dc.source.none.fl_str_mv |
reponame:Repositório Institucional da UnB instname:Universidade de Brasília (UnB) instacron:UNB |
instname_str |
Universidade de Brasília (UnB) |
instacron_str |
UNB |
institution |
UNB |
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Repositório Institucional da UnB |
collection |
Repositório Institucional da UnB |
repository.name.fl_str_mv |
Repositório Institucional da UnB - Universidade de Brasília (UnB) |
repository.mail.fl_str_mv |
repositorio@unb.br |
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