title: 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.
authors.affiliation: Consorcio de Investigaciones Bioclinicas (CIBIC), Bogotá, Colombia. JSoto@elsitio.net.co
authors.forename: J
authors.initials: J
authors.lastname: Soto
authors.forename: J
authors.initials: J
authors.lastname: Toledo
authors.forename: P
authors.initials: P
authors.lastname: Gutierrez
authors.forename: R S
authors.initials: RS
authors.lastname: Nicholls
authors.forename: J
authors.initials: J
authors.lastname: Padilla
authors.forename: J
authors.initials: J
authors.lastname: Engel
authors.forename: C
authors.initials: C
authors.lastname: Fischer
authors.forename: A
authors.initials: A
authors.lastname: Voss
authors.forename: J
authors.initials: J
authors.lastname: Berman
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000981:Antiprotozoal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003105:Colombia; D006801:Humans; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy*; D008297:Male; D008889:Military Personnel; D010767:Phosphorylcholine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000981:Antiprotozoal Agents; D010767:Phosphorylcholine; C039128:miltefosine