Treatment of American Cutaneous Leishmaniasis with Miltefosine, an Oral Agent

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 approximately 2% of treatment days. In this uncontrolled study of oral miltefosine for treatment of patients with American cutaneous leishmaniasis, a dosage of approximately 2.25 mg/kg/day for 3-4 weeks was effective and tolerated.

Current diagnosis and treatment of cutaneous and mucocutaneous leishmaniasis

“…Miltefosine was effective in curing patients with visceral leishmaniasis in India; however, few studies on the treatment of tegumentary leishmaniasis have been reported. In Colombia, a cure rate of 89-100% was observed for cutaneous leishmaniasis and was dependent on the dose used [86]; however, in general, the results in the New World are poor [87].…”

Thermoterapy effective and safer than miltefosine in the treatment of cutaneous leishmaniasis in Colombia

“…In Colombia, two studies have been conducted for the treatment of CL. The first is a phase I-II study with a reported cure rate by protocol of 66% in individuals who received a dose of 50-100 mg/day and of 95% in individuals who received a dose of 133-150 mg/day 23 . The second study was a multicenter study (Colombia and Guatemala) where miltefosine was compared against a placebo; this study showed contradictory results.…”

Leishmanicidal activities of the extract from Blepharocalyx salicifolius (Kunth) O. Berg, Myrtaceae

“…The usual drugs used on leihsmaniasis therapy present several adverse effects as nephrotoxicity, hepatotoxicity and low efficacy (Soto et al, 2001). Besides the fractions F11 and F12 present activity against amastigota Leishmania (L.) amazonensis cells, they were not toxic to blood human cells.…”