Comparison of the standard scheme and alternative meglumine antimoniate in the treatment of leishmaniasis mucocutaneous or mucosal

INTRODUCTION: In Rio de Janeiro State, Brazil, American tegumentary leishmaniasis (ATL) is caused by Leishmania (Viannia) braziliensis, whose transmission is dependent on the adaptation of the vector Lutzomyia intermedia to the home and peri-domestic environment. Mucocutaneous leishmaniasis (MCL) can cause deformities, with consequent psychological involvement and reflection on the social and economic fields. Brazilian Ministry of Health recommends treatment of the MCL patients with meglumine antimoniate (MA), 20mg Sb5+/kg/day during 30 days. However, there are reports of renal, cardiac, hepatic and pancreatic alterations, and even deaths. In the Laboratory of Leishmaniasis Surveillance of IPEC - Fiocruz, the dose of 5mg Sb5+/kg/day IM for at least 30 days has been effective and well tolerated. OBJECTIVE: To compare the effectiveness and safety between the standard scheme and an alternative regimen with MA in the treatment of patients with MCL. METHODS: Randomized controlled trial, double-blind, phase III, with 20 patients with MCL. Eligible subjects were randomly divided into groups of "high dose" (20mg Sb5+/ kg/day for 30 consecutive days), and "low dose" (5mg Sb5+/kg/day continued until cure, with a limit of 120 days of treatment). Adverse effects were monitored by clinical examination, serum biochemistry, blood count and electrocardiogram. RESULTS: From 20 eligible patients, 3 were excluded for breach of the treatment protocol. The age of the 17 studied patients ranged from 35 to 77 years, 94.4% were male and 94.1% acquired their infection in the Southeast Region of Brazil. Nasal mucosa was the most common location of the lesions (82.4%) and nasal obstruction was the most frequent symptom (64.7%). Twelve (70.6%) patients completed treatment and five (29.4%) did not, due to exclusion because of adverse effects. All 12 patients who completed treatment were cured within 120 days after the initiation of treatment. All patients had clinical, electrocardiographic and laboratory adverse effects. The mean age of patients who completed treatment was 51.92 + 12.83 years and of patients who did not complete it due to adverse effects was 68.40 + 7.34 years (p = 0.017). Dose of MA was not statistically associated with adverse effects, but among patients who had not completed treatment 60% had used "high dose". CONCLUSION: Considering there was no difference in efficacy between "low" and "high dose", and apparently adverse effects were more frequent in the "high dose" group, we recommend the use of "low dose" in the elderly.