title: Randomized controlled clinical trial to access efficacy and safety of miltefosine in the treatment of cutaneous leishmaniasis Caused by Leishmania (Viannia) guyanensis in Manaus, Brazil.
abstract: Miltefosine has been used in the treatment of several new world cutaneous leishmaniasis (CL) species with variable efficacy. Our study is the first evidence on its clinical efficacy in Leishmania (Viannia) guyanensis. In this phase II/III randomized clinical trial, 90 CL patients were randomly allocated (2:1) to oral miltefosine (2.5 mg/kg/day/28 days) (N = 60) or parenteral antimony (15-20 mg/Sb/kg/day/20 days) (N = 30) according to age groups: 2-12 y/o and 13-65 y/o. Patients were human immunodeficiency virus (HIV) noninfected parasitological proven CL without previous treatment. Definitive cure was accessed at 6 months follow-up visit. No severe adverse events occurred. Vomiting was the most frequent adverse event (48.3%) followed by nausea (8.6%) and diarrhea (6.7%). Cure rates were 71.4% (95% confidence interval [CI] = 57.8-82.7) and 53.6% (95% CI = 33.9-72.5) (P = 0.05) for miltefosine and antimonial, respectively. There were no differences in cure rates between age groups within the same treatment arms. Miltefosine was safe and relatively well tolerated and cure rate was higher than antimony.
authors.affiliation: Fundação de Medicina Tropical do Amazonas and Universidade Estadual do Amazonas, Manaus, AM, Brasil. anettetalhari@terra.com.br
authors.forename: Anette
authors.initials: A
authors.lastname: Chrusciak-Talhari
authors.forename: Reynaldo
authors.initials: R
authors.lastname: Dietze
authors.forename: Carolina
authors.initials: C
authors.lastname: Chrusciak Talhari
authors.forename: Roberto Moreira
authors.initials: RM
authors.lastname: da Silva
authors.forename: Ellen Priscila
authors.initials: EP
authors.lastname: Gadelha Yamashita
authors.forename: Gerson
authors.initials: G
authors.lastname: de Oliveira Penna
authors.forename: Paulo Roberto
authors.initials: PR
authors.lastname: Lima Machado
authors.forename: Sinésio
authors.initials: S
authors.lastname: Talhari
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000981:Antiprotozoal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001938:Brazil; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D018334:Leishmania guyanensis / Q000187:drug effects*; D007897:Leishmaniasis, Mucocutaneous / Q000188:drug therapy*; D008297:Male; D008536:Meglumine / Q000009:adverse effects / Q000627:therapeutic use; D000077485:Meglumine Antimoniate; D008875:Middle Aged; D009942:Organometallic Compounds / Q000009:adverse effects / Q000627:therapeutic use; D010767:Phosphorylcholine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000981:Antiprotozoal Agents; D009942:Organometallic Compounds; D010767:Phosphorylcholine; C039128:miltefosine; D008536:Meglumine; D000077485:Meglumine Antimoniate