title: Treatment of Bolivian mucosal leishmaniasis with miltefosine.
abstract: BACKGROUND
  Although mucosal leishmaniasis is a prominent disease, it has been studied only to a limited extent. It is classically treated with parenteral antimony or, as a last resort, amphotericin B.
  
  
  METHODS
  We treated Bolivian mucosal leishmaniasis due to Leishmania braziliensis with the oral agent miltefosine, 2.5 mg/kg/day for 28 days, and followed-up for 12 months.
  
  
  RESULTS
  Seventy-two patients were evaluable. The cure rate for the 36 patients who had "mild" disease (i.e., affecting nasal skin and nasal mucosa) was 83%. The cure rate for the 36 patients who had more extensive disease (involving the palate, pharynx, and larynx) was 58%. Patients refused to be randomized to parenteral agents, but the cure rate for an almost contemporary group who was receiving amphotericin B (45 mg/kg over 90 days) was 7 (50%) of 14.
  
  
  CONCLUSIONS
  In this unrandomized trial, oral miltefosine was at least as effective as heroic doses of parenteral amphotericin B. The cure rate for miltefosine was approximately equivalent to historical cure rates using parenteral pentavalent antimony for mild and extensive disease in neighboring Peru. Although gastrointestinal side reactions do occur with miltefosine, its toxicity profile is superior to that of antimony and far superior to that of amphotericin B--in part because of the inherent attractiveness of oral versus parenteral agents. Our results suggest that miltefosine should be the treatment of choice for mucosal disease in North and South America.
authors.affiliation: Consorcio de Investigaciones Bioclinicas, Bogota, Colombia. Jaime.Soto@medplus.org.co
authors.forename: J
authors.initials: J
authors.lastname: Soto
authors.forename: J
authors.initials: J
authors.lastname: Toledo
authors.forename: L
authors.initials: L
authors.lastname: Valda
authors.forename: M
authors.initials: M
authors.lastname: Balderrama
authors.forename: I
authors.initials: I
authors.lastname: Rea
authors.forename: R
authors.initials: R
authors.lastname: Parra
authors.forename: J
authors.initials: J
authors.lastname: Ardiles
authors.forename: P
authors.initials: P
authors.lastname: Soto
authors.forename: A
authors.initials: A
authors.lastname: Gomez
authors.forename: F
authors.initials: F
authors.lastname: Molleda
authors.forename: C
authors.initials: C
authors.lastname: Fuentelsaz
authors.forename: G
authors.initials: G
authors.lastname: Anders
authors.forename: H
authors.initials: H
authors.lastname: Sindermann
authors.forename: J
authors.initials: J
authors.lastname: Engel
authors.forename: J
authors.initials: J
authors.lastname: Berman
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D000981:Antiprotozoal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001838:Bolivia; D005260:Female; D006801:Humans; D007892:Leishmania braziliensis / Q000187:drug effects*; D007897:Leishmaniasis, Mucocutaneous / Q000188:drug therapy*; D008297:Male; D010767:Phosphorylcholine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000981:Antiprotozoal Agents; D010767:Phosphorylcholine; C039128:miltefosine