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

Detalhes bibliográficos
Autor(a) principal: Borges, Myrlena Mescouto
Data de Publicação: 2017
Outros Autores: Pranchevicius, Maria Cristina da Silva, Noronha, Elza Ferreira, Romero, Gustavo Adolfo Sierra, Carranza Tamayo, César Omar
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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spelling 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
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language eng
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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
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instname_str Universidade de Brasília (UnB)
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reponame_str Repositório Institucional da UnB
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repository.name.fl_str_mv Repositório Institucional da UnB - Universidade de Brasília (UnB)
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