Miltefosine in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania braziliensis in Brazil: A Randomized and Controlled Trial

Abstract

Cutaneous leishmaniasis (CL) is characterized by skin ulcerations and occurs in rural poor areas of developing countries. It is treated with daily injections of antimony for 20 days, which is associated with irregular use and increasingly lower cure rates. Miltefosine is an oral medication with activity against the agent of CL (Leishmania). We have studied the efficacy and safety of miltefosine compared with antimony in patients with CL caused by Leishmania braziliensis in Bahia, Brazil. A total of 90 patients participated; 60 received miltefosine and 30 were treated with antimony. Six months after treatment, 75% of patients treated with miltefosine were cured, compared with 53% of the patients in the antimony group, a difference considered significant (p = 0.04). We also found that miltefosine was more effective than antimony in adults than in children. The incidence of side effects was similar with both drugs (76.7% vs. 78.3%), but all patients were able to finish the treatments. Our study shows that miltefosine is more effective than antimony for the treatment of CL in Bahia, Brazil and can contribute to the control of this disease due to its activity and easier administration