Treatment of American Cutaneous Leishmaniasis with Miltefosine, an Oral Agent

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Abstract
There is no recognized oral treatment for American cutaneous leishmaniasis. A rising-dose, open-label phase I/II trial of the oral agent miltefosine against Colombian cutaneous leishmaniasis was conducted. Seventy-two male Colombian soldiers (mean weight, 67 kg) received miltefosine at 50–100 mg/day for 3 weeks (for 32 evaluable patients) or at 133–150 mg/day for 3–4 weeks (for 32 evaluable patients). The per-protocol cure rate for 50–100 mg/day was 21 (66%) of 32 patients. The per-protocol cure rate for 133–150 mg/day was 30 (94%) of 32 patients (P = .01, by use of Fisher's exact test). The historic per-protocol cure rate for standard injections of antimony is 93%. “Motion sickness” that did not interfere with normal duties was experienced by 40% of patients and was dose related. Vomiting and diarrhea were reported on ∼2% of treatment days. In this uncontrolled study of oral miltefosine for treatment of patients with American cutaneous leishmaniasis, a dosage of ∼2.25 mg/kg/day for 3–4 weeks was effective and tolerated.