Abstract
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. 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. 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. Miltefosine may be an interesting alternative for treating ML because of its oral administration and cure rate after long-term follow-up.
Highlights
The treatment of mucosal leishmaniasis (ML) is difficult due to the toxicity and route of administration of standard drugs
We aimed to evaluate the efficacy of miltefosine for ML treatment compared to that of pentavalent antimonial in a pilot study
We observed no differences in cure probability between miltefosine and N-MA
Summary
The treatment of mucosal leishmaniasis (ML) is difficult due to the toxicity and route of administration of standard drugs. 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. We observed no differences in cure probability between miltefosine and N-MA (relative risk = 0.66; 95% CI = 0.33–1.32). The standard treatment for mucosal leishmaniasis (ML) defined by the World Health Organization (WHO), the Pan American Health Organization (PAHO), and the Brazilian Ministry of Health (MS) is a relatively toxic dose of N-methylglucamine (N-MA) at 20 mg SbV/kg/day for 30 days by parenteral route. Sampaio RNR et al - Mucosal leishmaniasis treatment with miltefosine in 30%–42% of treated patients[1,11,14]. Secondline treatment options include drugs such as amphotericin B and pentamidine; they are administered by injection and have numerous severe adverse reactions[16]
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have