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A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis

INTRODUCTION: The treatment of mucosal leishmaniasis (ML) is difficult due to the toxicity and route of administration of standard drugs. Miltefosine is an oral agent used for leishmaniasis treatment; however, no data exist regarding its use for ML in Brazil. In this study, we aimed to evaluate the...

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Main Authors: Sampaio, Raimunda Nonata Ribeiro, Silva, Juliana Saboia Fontenele e, Paula, Carmen Dea Ribeiro de, Porto, Cláudia, Motta, Jorgeth de Oliveira Carneiro da, Pereira, Ledice Inacia de Araujo, Martins, Sofia Sales, Barroso, Daniel Holanda, Freire, Gustavo Subtil Magalhães, Gomes, Ciro Martins
Format: Artigo
Language: English
Published: Sociedade Brasileira de Medicina Tropical - SBMT 2020
Subjects:
Leishmaniose
Leishmaniose tegumentar americana
Ensaios clínicos
Terapêutica
Medicamentos
Online Access: https://repositorio.unb.br/handle/10482/36245
https://doi.org/10.1590/0037-8682-0292-2018
http://orcid.org/0000-0002-8223-0058
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spelling ir-10482-362452020-05-22T14:00:55Z A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis Sampaio, Raimunda Nonata Ribeiro Silva, Juliana Saboia Fontenele e Paula, Carmen Dea Ribeiro de Porto, Cláudia Motta, Jorgeth de Oliveira Carneiro da Pereira, Ledice Inacia de Araujo Martins, Sofia Sales Barroso, Daniel Holanda Freire, Gustavo Subtil Magalhães Gomes, Ciro Martins Leishmaniose Leishmaniose tegumentar americana Ensaios clínicos Terapêutica Medicamentos INTRODUCTION: The treatment of mucosal leishmaniasis (ML) is difficult due to the toxicity and route of administration of standard drugs. Miltefosine is an oral agent used for leishmaniasis treatment; however, no data exist regarding its use for ML in Brazil. In this study, we aimed to evaluate the efficacy of miltefosine for ML treatment compared to that of pentavalent antimonial in a pilot study. METHODS: We performed a randomized clinical trial with two parallel groups. The tested intervention consisted of miltefosine 1.3-2 mg/kg/day (two capsules) for 28 days or intravenous 20 mg SbV/kg/day of meglumine antimoniate (N-MA) for 30 days. The final endpoint was defined as complete healing of the lesion four years after treatment. We also analyzed an early endpoint at 90 days after treatment. RESULTS: Forty patients were included in this study: each experimental group comprised 20 patients. Applying a multivariate model in an intention-to-treat analysis, we observed that patients treated with miltefosine had a cure probability 2.08 times greater (95% confidence interval [CI] = 1.03-4.18) than those treated with N-MA at 90 days after treatment. At the final endpoint, we observed no differences in cure probability between miltefosine and N-MA (relative risk = 0.66; 95% CI = 0.33-1.32). With respect to adverse reactions, significant differences between groups were related to gastrointestinal effects, which were more frequent in the miltefosine group. CONCLUSIONS: Miltefosine may be an interesting alternative for treating ML because of its oral administration and cure rate after long-term follow-up. 2020-01-24T10:29:59Z 2020-01-24T10:29:59Z 2019 Artigo SAMPAIO, Raimunda Nonata Ribeiro et al. A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis. Revista da Sociedade Brasileira de Medicina Tropical. v. 52, e20180292, 2019. DOI: https://doi.org/10.1590/0037-8682-0292-2018. Disponível em: http://scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822019000100315. Acesso em: 23 janeiro 2020. https://repositorio.unb.br/handle/10482/36245 https://doi.org/10.1590/0037-8682-0292-2018 http://orcid.org/0000-0002-8223-0058 en Acesso Aberto OPEN ACCESS - https://creativecommons.org/licenses/by/4.0/. (CC BY). application/pdf Sociedade Brasileira de Medicina Tropical - SBMT
institution REPOSITORIO UNB
collection REPOSITORIO UNB
language English
topic Leishmaniose
Leishmaniose tegumentar americana
Ensaios clínicos
Terapêutica
Medicamentos
spellingShingle Leishmaniose
Leishmaniose tegumentar americana
Ensaios clínicos
Terapêutica
Medicamentos
Sampaio, Raimunda Nonata Ribeiro
Silva, Juliana Saboia Fontenele e
Paula, Carmen Dea Ribeiro de
Porto, Cláudia
Motta, Jorgeth de Oliveira Carneiro da
Pereira, Ledice Inacia de Araujo
Martins, Sofia Sales
Barroso, Daniel Holanda
Freire, Gustavo Subtil Magalhães
Gomes, Ciro Martins
A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis
description INTRODUCTION: The treatment of mucosal leishmaniasis (ML) is difficult due to the toxicity and route of administration of standard drugs. Miltefosine is an oral agent used for leishmaniasis treatment; however, no data exist regarding its use for ML in Brazil. In this study, we aimed to evaluate the efficacy of miltefosine for ML treatment compared to that of pentavalent antimonial in a pilot study. METHODS: We performed a randomized clinical trial with two parallel groups. The tested intervention consisted of miltefosine 1.3-2 mg/kg/day (two capsules) for 28 days or intravenous 20 mg SbV/kg/day of meglumine antimoniate (N-MA) for 30 days. The final endpoint was defined as complete healing of the lesion four years after treatment. We also analyzed an early endpoint at 90 days after treatment. RESULTS: Forty patients were included in this study: each experimental group comprised 20 patients. Applying a multivariate model in an intention-to-treat analysis, we observed that patients treated with miltefosine had a cure probability 2.08 times greater (95% confidence interval [CI] = 1.03-4.18) than those treated with N-MA at 90 days after treatment. At the final endpoint, we observed no differences in cure probability between miltefosine and N-MA (relative risk = 0.66; 95% CI = 0.33-1.32). With respect to adverse reactions, significant differences between groups were related to gastrointestinal effects, which were more frequent in the miltefosine group. CONCLUSIONS: Miltefosine may be an interesting alternative for treating ML because of its oral administration and cure rate after long-term follow-up.
format Artigo
author Sampaio, Raimunda Nonata Ribeiro
Silva, Juliana Saboia Fontenele e
Paula, Carmen Dea Ribeiro de
Porto, Cláudia
Motta, Jorgeth de Oliveira Carneiro da
Pereira, Ledice Inacia de Araujo
Martins, Sofia Sales
Barroso, Daniel Holanda
Freire, Gustavo Subtil Magalhães
Gomes, Ciro Martins
author_sort Sampaio, Raimunda Nonata Ribeiro
title A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis
title_short A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis
title_full A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis
title_fullStr A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis
title_full_unstemmed A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis
title_sort randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis
publisher Sociedade Brasileira de Medicina Tropical - SBMT
publishDate 2020
url https://repositorio.unb.br/handle/10482/36245
https://doi.org/10.1590/0037-8682-0292-2018
http://orcid.org/0000-0002-8223-0058
_version_ 1672205967197995008
score 13.657419

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