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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.
Financial support: This study is part of a National Multicenter Clinical Trial for the evaluation of miltefosine in the treatment of cutaneous leishmaniasis caused by L. (V.) guyanensis and L. (V.) braziliensis. Both studies were conducted in Brazil. The current study was funded by FINEP/Brazil (project no. 3726/05) and coordinated by the Núcleo de Medicina Tropical from the University of Brasília, Brasília, DF, Brazil. The present manuscript refers to the study arm performed at the Fundação de Medicina Tropical do Amazonas with patients infected with L. (V.) guyanensis. The other arm was conducted at the Immunology Service of the University Hospital Professor Edgar Santos at the Federal University of Bahia, on patients infected with L. (V.) braziliensis with financial support of CNPq no. 410559/2006-7 (edital mct/cnpq/ms/sctie/decit 25/2006). Miltefosine (Impavido), was supplied by Zentaris GmbH (presently Aeterna Zentaris GmbH).
Authors' addresses: Anette Chrusciak-Talhari, Fundação de Medicina Tropical do Amazonas, Universidade Estadual do Amazonas, Manaus, AM, Brasil, E-mail: email@example.com. Reynaldo Dietze, Núcleo de Doenças Infecciosas, Universidade Federal do Espírito Santo, Vitória, ES, Brasil, E-mail: firstname.lastname@example.org. Carolina Chrusciak Talhari, Fundação de Medicina Tropical do Amazonas, Manaus, AM, Brasil, E-mail: email@example.com. Roberto Moreira da Silva, Fundação de Medicina Tropical do Amazonas, Manaus, AM, Brasil, E-mail: firstname.lastname@example.org. Ellen Priscila Gadelha Yamashita, Fundação de Medicina Tropical do Amazonas, Manaus, AM, Brasil, E-mail: email@example.com. Gerson de Oliveira Penna, Núcleo de Medicina Tropical, Universidade de Brasilia, Brasilia, DF, Brasil, E-mails: firstname.lastname@example.org or email@example.com. Paulo Roberto Lima Machado, Serviço de Imunologia, Hosp. Univ. Prof. Edgar Santos, Universidade Federal da Bahia, Salvador, BA, Brasil, E-mail: firstname.lastname@example.org. Sinésio Talhari, Fundação de Medicina Tropical do Amazonas, Manaus, AM, Brasil, E-mail: email@example.com.