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

Autor:	Sampaio RNR; Laboratório de Dermatomicologia, Faculdade de Medicina, Universidade de Brasília, Brasília, DF, Brasil.; Hospital Universitário de Brasília, Universidade de Brasília, Brasília, DF, Brasil.; Pós-graduação Stricto Sensu em ciências da saúde, Universidade de Brasília, Brasília, DF, Brasil., Silva JSFE; Secretaria de Saúde do Distrito Federal, Brasília, DF, Brasil., Paula CDR; Hospital Universitário de Brasília, Universidade de Brasília, Brasília, DF, Brasil., Porto C; Hospital Universitário de Brasília, Universidade de Brasília, Brasília, DF, Brasil., Motta JOCD; Hospital Universitário de Brasília, Universidade de Brasília, Brasília, DF, Brasil., Pereira LIA; Secretaria de Estado da Saúde de Goiás, Hospital de Doenças Tropicais, Goiânia, GO, Brasil., Martins SS; Pós-graduação Stricto Sensu em ciências da saúde, Universidade de Brasília, Brasília, DF, Brasil., Barroso DH; Pós-graduação Stricto Sensu em ciências da saúde, Universidade de Brasília, Brasília, DF, Brasil., Freire GSM; Hospital Universitário de Brasília, Universidade de Brasília, Brasília, DF, Brasil., Gomes CM; Laboratório de Dermatomicologia, Faculdade de Medicina, Universidade de Brasília, Brasília, DF, Brasil.; Hospital Universitário de Brasília, Universidade de Brasília, Brasília, DF, Brasil.
Jazyk:	angličtina
Zdroj:	Revista da Sociedade Brasileira de Medicina Tropical [Rev Soc Bras Med Trop] 2019 Mar 28; Vol. 52, pp. e20180292. Date of Electronic Publication: 2019 Mar 28.
DOI:	10.1590/0037-8682-0292-2018
Abstrakt:	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.
Databáze:	MEDLINE
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