Ellen Priscilla

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Anette Chrusciak Talhari

Fundação de Medicina Tropical

Jorge Augusto

Universidade do Porto

Leandro Ourives Neves

Universidade Federal de Goiás

Nunes Gadelha

Luíz Carlos de Lima Ferreira

Fundação de Medicina Tropical

Roberto Moreira da Silva Júnior

Universidade Federal do Amazonas

Oliveira Guerra

Amazon (Germany)

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Fundação de Medicina Tropical

Universidade do Estado do Amazonas

Universidade Federal do Amazonas

Division of Undergraduate Education

Universidade do Porto

Hospital do Espírito Santo

Universidade Federal de Goiás

Hospital for Tropical Diseases

Escola Superior de Ciências da Saúde

Fundação Getulio Vargas

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A randomized clinical trial comparing meglumine antimoniate, pentamidine and amphotericin B for the treatment of cuta- neous leishmaniasis by Leishmania guyanensis * Estudo clínico randomizado comparando antimoniato de meglumina, pentami- dina e anfotericina B para o tratamento da leishmaniose cutânea ocasionada por Leishmania guyanensis

Leandro Ourives Neves Anette Chrusciak Talhari Ellen Priscilla Nunes Gadelha Roberto Moreira da Silva Júnior

Fundamentals: 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. O BJECTIVES: 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. M ETHODS: 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-exam- ined one, two and six months after completion of treatment. R ESULTS: 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. C

Meglumine antimoniate

Pentamidine

Meglumine

Tolerability

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