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Title: Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil : a randomized and controlled trial
Authors: Machado, Paulo R.
Ampuero, Julia
Guimarães, Luiz H.
Villasboas, Leonardo
Rocha, Ana T.
Schriefer, Albert
Sousa, Rosana S.
Talhari, Anette
Penna, Gerson Oliveira
Carvalho, Edgar M.
Assunto:: Leishmaniose cutânea
Leishmaniose cutânea - tratamento
Issue Date: 21-Dec-2010
Publisher: Plos Neglected Tropical Diase
Citation: MACHADO, Paulo R. et al. Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial. Plos Neglected Tropical Diases, v. 4, n. 12, Article e912, 21 dez. 2010. Disponível em: <>. Acesso em: 14 jun. 217. doi:
Abstract: Background: Cutaneous leishmaniasis (CL) is treated with parenteral drugs for decades with decreasing rate cures. Miltefosine is an oral medication with anti leishmania activity and may increase the cure rates and improve compliance. Methodology/Principal Findings: This study is a randomized, open-label, controlled clinical trial aimed to evaluate the efficacy and safety of miltefosine versus pentavalent antimony (Sbv) in the treatment of patients with CL caused by Leishmania braziliensis in Bahia, Brazil. A total of 90 patients were enrolled in the trial; 60 were assigned to receive miltefosine and 30 to receive Sbv. Six months after treatment, in the intention-to-treat analyses, the definitive cure rate was 53.3% in the Sbv group and 75% in the miltefosine group (difference of 21.7%, 95% CI 0.08% to 42.7%, p = 0.04). Miltefosine was more effective than Sbv in the age group of 13–65 years-old compared to 2–12 years-old group (78.9% versus 45% p = 0.02; 68.2% versus 70% p = 1.0, respectively). The incidence of adverse events was similar in the Sbv and miltefosine groups (76.7% vs. 78.3%). Vomiting (41.7%), nausea (40%), and abdominal pain (23.3%) were significantly more frequent in the miltefosine group while arthralgias (20.7%), mialgias (20.7%) and fever (23.3%) were significantly more frequent in the Sbv group. Conclusions: This study demonstrates that miltefosine therapy is more effective than standard Sbv and safe for the treatment of CL caused by Leishmania braziliensis in Bahia, Brazil.
Licença:: Copyright: 2010 Machado et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Appears in Collections:FMD - Artigos publicados em periódicos e preprints

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