Article
Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial
Registro en:
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 Diseases, [San Francisco], v. 12, n. 4, p.1-6, Dec. 2010.
1935-2727
10.1371/journal.pntd.0000912
Autor
Machado, Paulo Roberto Lima
Ampuero, Julia
Guimarães, Luiz Henrique Santos
Villasboas, Leonardo
Rocha, Ana T.
Schriefer, Albert
Sousa, Rosana S.
Talhari, Anette Chursciack
Penna, Gerson Oliveira
Carvalho, Edgar Marcelino
Resumen
Gerson Oliveira Penna - Fundação Oswaldo Cruz. Fiocruz Brasília. Brasília, DF, Brasil. Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta à informação no documento do vinculo com a unidade da Fiocruz Brasília. 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.