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

• Autor(a) principal: Sampaio,Raimunda Nonata Ribeiro
• Data de Publicação: 2019
• Outros Autores: 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
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Revista da Sociedade Brasileira de Medicina Tropical
• Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822019000100315
• topic: Leishmaniasis; Mucosal Leishmaniasis; Controlled Clinical Trial; Pentavalent antimonial; Therapeutics; Miltefosine.

Abstract 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.