Association of miltefosine with granulocyte and macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis in the Amazon region: A randomized and controlled trial
Luciana Mendes, Jorge Oliveira Guerra, Bleno Costa, Aríneia Soares da Silva, Maria das Graças Barbosa Guerra, Jéssica Ortiz, Susan Smith Doria, George Villarouco da Silva, Denison Vital de Jesus, Manoel Barral-Netto, Gerson Penna, Edgar M Carvalho, Paulo R L Machado, Luciana Mendes, Jorge Oliveira Guerra, Bleno Costa, Aríneia Soares da Silva, Maria das Graças Barbosa Guerra, Jéssica Ortiz, Susan Smith Doria, George Villarouco da Silva, Denison Vital de Jesus, Manoel Barral-Netto, Gerson Penna, Edgar M Carvalho, Paulo R L Machado
Abstract
Objectives: To compare topical granulocyte and macrophage colony-stimulating factor (GM-CSF) and miltefosine (G + M) versus placebo and miltefosine (P + M) or parenteral meglumine antimoniate (MA) in the treatment of 150 patients with cutaneous leishmaniasis (CL) caused by Leishmania guyanensis in the Amazon.
Design: A randomized and double-blinded clinical trial.
Results: At 90 days after the initiation of therapy, the cure rates were 66%, 58%, and 52% for the groups P + M, G + M, and MA, respectively (p > 0.05). Cure rates at 180 days did not differ. Healing time was similar in the 3 groups, but faster in the MA group as compared to the G + M group (p = 0.04). Mild and transitory systemic adverse events were frequent in all groups (above 85%). Nausea (85%) and vomiting (39%) predominated in the miltefosine groups and arthralgia (51%) and myalgia (48%) in the MA group. One patient (group MA) stopped treatment after presenting with fever, exanthema, and severe arthralgia.
Conclusions: Miltefosine did not present a higher cure rate than MA, and the association of GM-CSF did not improve the therapeutic response. Nevertheless, because of its less toxicity, easier administration, and a similar cure rate when compared with MA, miltefosine should remain as one of the main drugs for treating CL due to L. guyanensis. (Clinicaltrials.gov Identifier NCT03023111).
Keywords: Cutaneous leishmaniasis; GM-CSF; L. guyanensis; Meglumine antimoniate; Miltefosine.
Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.
Source: PubMed