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

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Autor(es): dc.creatorSampaio, Raimunda Nonata Ribeiro-
Autor(es): dc.creatorSilva, Juliana Saboia Fontenele e-
Autor(es): dc.creatorPaula, Carmen Dea Ribeiro de-
Autor(es): dc.creatorPorto, Cláudia-
Autor(es): dc.creatorMotta, Jorgeth de Oliveira Carneiro da-
Autor(es): dc.creatorPereira, Ledice Inacia de Araujo-
Autor(es): dc.creatorMartins, Sofia Sales-
Autor(es): dc.creatorBarroso, Daniel Holanda-
Autor(es): dc.creatorFreire, Gustavo Subtil Magalhães-
Autor(es): dc.creatorGomes, Ciro Martins-
Data de aceite: dc.date.accessioned2021-10-14T18:24:29Z-
Data de disponibilização: dc.date.available2021-10-14T18:24:29Z-
Data de envio: dc.date.issued2020-01-23-
Data de envio: dc.date.issued2020-01-23-
Data de envio: dc.date.issued2019-
Fonte completa do material: dc.identifierhttps://repositorio.unb.br/handle/10482/36245-
Fonte completa do material: dc.identifierhttps://doi.org/10.1590/0037-8682-0292-2018-
Fonte completa do material: dc.identifierhttp://orcid.org/0000-0002-8223-0058-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/capes/630908-
Descrição: dc.descriptionINTRODUCTION: 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.-
Formato: dc.formatapplication/pdf-
Idioma: dc.languageen-
Publicador: dc.publisherSociedade Brasileira de Medicina Tropical - SBMT-
Direitos: dc.rightsAcesso Aberto-
Direitos: dc.rightsOPEN ACCESS - https://creativecommons.org/licenses/by/4.0/. (CC BY).-
Palavras-chave: dc.subjectLeishmaniose-
Palavras-chave: dc.subjectLeishmaniose tegumentar americana-
Palavras-chave: dc.subjectEnsaios clínicos-
Palavras-chave: dc.subjectTerapêutica-
Palavras-chave: dc.subjectMedicamentos-
Título: dc.titleA randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis-
Tipo de arquivo: dc.typelivro digital-
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