Universidad Peruana Cayetano Heredia

A phase II multicenter randomized study to evaluate the safety and efficacy of combining thermotherapy and a short course of miltefosine for the treatment of uncomplicated cutaneous leishmaniasis in the New World.

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dc.contributor.author Lopez, Liliana
dc.contributor.author Alvarez, Fiorela
dc.contributor.author Ramos, Ana Pilar
dc.contributor.author Llanos Cuentas, Elmer Alejandro
dc.contributor.author Echevarria Zarate, Juan Ignacio
dc.contributor.author Velez, Ivan
dc.contributor.author Boni, Marina
dc.contributor.author Rode, Joelle
dc.contributor.author Quintero, Juliana
dc.contributor.author Jimenez, Alejandra
dc.contributor.author Tabares, Yulied
dc.contributor.author Mendez, Claudia
dc.contributor.author Arana, Byron
dc.date.accessioned 2022-03-23T16:54:19Z
dc.date.available 2022-03-23T16:54:19Z
dc.date.issued 2022
dc.identifier.uri https://hdl.handle.net/20.500.12866/11459
dc.description.abstract Background: Systemic pentavalent antimonials, mainly meglumine antimoniate, continue to be the first-choice drugs for treatment of cutaneous leishmaniasis (CL) despite their toxicity, difficulty of administration and high cost. In the search for therapeutic alternatives, combining two treatment interventions has emerged as a potential alternative to either reduce the use of antimonials with the associated toxicities, or to increase efficacy. Here, we report the results of a recently completed trial assessing the efficacy and safety of a combination of thermotherapy (TT) plus a short course of miltefosine (MLT) for the treatment of uncomplicated CL in Colombia and Peru. Methods: A multicenter, randomized, evaluator-blinded, phase II, controled clinical trial was conducted. Adult volunteers with a parasitologically confirmed diagnosis of uncomplicated CL were randomly allocated to receive either a single session of TT or a combination of TT plus a short course of MLT (3 weeks). Therapeutic response outcomes and safety were assessed. Results: 130 subjects were included in the study, of whom 64 were randomly assigned to the TT arm and 66 to the TT + MLT arm. Cure at 3 months’ follow-up was achieved in 57.8% (n = 37) and 80.3% (n = 53) in the TT and TT + MLT groups, respectively, in the intention to treat analysis. The TT + MLT regimen was better that TT alone (p = 0.0055). The presence of vesicles at the site of heat application was the most common adverse event reported associated with the use of TT; while vomiting (31.8%) and elevation of liver enzymes (28.8%) were the most frequent adverse events reported associated with the use of MLT. Conclusion: The combination of TT plus a short course of MLT was shown to be significantly better than TT alone for the treatment of uncomplicated CL in the New World. en_US
dc.language.iso eng
dc.publisher Public Library of Science
dc.relation.ispartofseries PLoS Neglected Tropical Diseases
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject phase II multicenter randomized study en_US
dc.subject safety and efficacy en_US
dc.subject thermotherapy en_US
dc.subject short course en_US
dc.subject miltefosine en_US
dc.subject treatment en_US
dc.subject cutaneous leishmaniasis en_US
dc.title A phase II multicenter randomized study to evaluate the safety and efficacy of combining thermotherapy and a short course of miltefosine for the treatment of uncomplicated cutaneous leishmaniasis in the New World. en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1371/journal.pntd.0010238
dc.relation.issn 1935-2735


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