A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis
Rev. Soc. Bras. Med. Trop
;
52: e20180292, 2019. tab, graf
Artículo
en Inglés
| LILACS
| ID: biblio-990435
ABSTRACT
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.
Texto completo:
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Índice:
LILACS (Américas)
Asunto principal:
Fosforilcolina
/
Leishmaniasis Mucocutánea
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Antimoniato de Meglumina
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Antiprotozoarios
Tipo de estudio:
Ensayo Clínico Controlado
/
Estudio de etiología
/
Estudio pronóstico
Límite:
Femenino
/
Humanos
/
Masculino
Idioma:
Inglés
Revista:
Rev. Soc. Bras. Med. Trop
Asunto de la revista:
Medicina Tropical
Año:
2019
Tipo del documento:
Artículo
País de afiliación:
Brasil
Institución/País de afiliación:
Secretaria de Estado da Saúde de Goiás/BR
/
Secretaria de Saúde do Distrito Federal/BR
/
Universidade de Brasília/BR
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