title: A randomized clinical trial comparing meglumine antimoniate, pentamidine and amphotericin B for the treatment of cutaneous leishmaniasis by Leishmania guyanensis.
abstract: OBJECTIVE
  American tegumentary leishmaniasis (ATL) treatment remains a challenge, since most available drugs are injectable and only a small number of comparative, randomized clinical trials have been performed to support their use. Moreover, treatment outcome may depend on the causative species of Leishmania.
  
  
  OBJECTIVE
  To evaluate and compare the efficacy and tolerability of meglumine antimoniate, pentamidine isethionate, and amphotericin B in the treatment of ATL caused by Leishmania (Viannia) guyanensis.
  
  
  METHODS
  185 patients were selected according to the eligibility criteria and randomly allocated into three groups - two groups with 74 patients each, and one group with 37 patients, which underwent meglumine, pentamidine and amphotericin B treatment, respectively. Doses, mode of administration and time periods of treatment followed the current recommendations for each drug. Patients were re-examined one, two and six months after completion of treatment.
  
  
  RESULTS
  No differences were observed among the therapeutic groups in relation to gender, age, number or site of lesions. Intention-to-treat (ITT) analysis showed efficacy of 58.1% for pentamidine and 55.5% for meglumine (p=0.857). The amphotericin B group was analyzed separately, since 28 patients (75.7%) in this group refused to continue participating in the study. Mild or moderate adverse effects were reported by 74 (40%) patients, especially arthralgia (20.3%) in the meglumine group, and pain (35.1%) or induration (10.8%) at the site of injection in the pentamidine group.
  
  
  CONCLUSIONS
  Pentamidine and meglumine show similar efficacy in the treatment of ATL caused by L. guyanensis. Given the low efficacy of both drugs, there is an urgent need for new therapeutical approaches.
authors.affiliation: Tropical Medicine Foundation of Amazonas, Manaus, Brazil. lourives@ig.com.br
authors.forename: Leandro Ourives
authors.initials: LO
authors.lastname: Neves
authors.forename: Anette Chrusciak
authors.initials: AC
authors.lastname: Talhari
authors.forename: Ellen Priscilla Nunes
authors.initials: EP
authors.lastname: Gadelha
authors.forename: Roberto Moreira da
authors.initials: RM
authors.lastname: Silva Júnior
authors.forename: Jorge Augusto de Oliveira
authors.initials: JA
authors.lastname: Guerra
authors.forename: Luiz Carlos de Lima
authors.initials: LC
authors.lastname: Ferreira
authors.forename: Sinésio
authors.initials: S
authors.lastname: Talhari
mesh_terms: D000293:Adolescent; D000328:Adult; D000666:Amphotericin B / Q000627:therapeutic use*; D000981:Antiprotozoal Agents / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D018334:Leishmania guyanensis / Q000469:parasitology*; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy*; D008297:Male; D008536:Meglumine / Q000627:therapeutic use*; D000077485:Meglumine Antimoniate; D008875:Middle Aged; D009942:Organometallic Compounds / Q000627:therapeutic use*; D010419:Pentamidine / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000981:Antiprotozoal Agents; D009942:Organometallic Compounds; D010419:Pentamidine; D008536:Meglumine; D000077485:Meglumine Antimoniate; D000666:Amphotericin B