Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial.
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.This study is a randomized, open-label, controlled clinical trial aimed to eval...
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ftdoajarticles:oai:doaj.org/article:fed5a58e5fb04ecead71ad89bc5a3d97 2023-05-15T15:10:59+02:00 Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial. Paulo R Machado Julia Ampuero Luiz H Guimarães Leonardo Villasboas Ana T Rocha Albert Schriefer Rosana S Sousa Anette Talhari Gerson Penna Edgar M Carvalho 2010-12-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0000912 https://doaj.org/article/fed5a58e5fb04ecead71ad89bc5a3d97 EN eng Public Library of Science (PLoS) http://europepmc.org/articles/PMC3006132?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0000912 https://doaj.org/article/fed5a58e5fb04ecead71ad89bc5a3d97 PLoS Neglected Tropical Diseases, Vol 4, Iss 12, p e912 (2010) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2010 ftdoajarticles https://doi.org/10.1371/journal.pntd.0000912 2022-12-31T11:53:48Z 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.This study is a randomized, open-label, controlled clinical trial aimed to evaluate the efficacy and safety of miltefosine versus pentavalent antimony (Sb(v)) 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 Sb(v). Six months after treatment, in the intention-to-treat analyses, the definitive cure rate was 53.3% in the Sb(v) 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 Sb(v) 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 Sb(v) 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 Sb(v) group.This study demonstrates that miltefosine therapy is more effective than standard Sb(v) and safe for the treatment of CL caused by Leishmania braziliensis in Bahia, Brazil.Clinicaltrials.gov Identifier NCT00600548. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLoS Neglected Tropical Diseases 4 12 e912 |
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Directory of Open Access Journals: DOAJ Articles |
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English |
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Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Paulo R Machado Julia Ampuero Luiz H Guimarães Leonardo Villasboas Ana T Rocha Albert Schriefer Rosana S Sousa Anette Talhari Gerson Penna Edgar M Carvalho Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial. |
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Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
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.This study is a randomized, open-label, controlled clinical trial aimed to evaluate the efficacy and safety of miltefosine versus pentavalent antimony (Sb(v)) 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 Sb(v). Six months after treatment, in the intention-to-treat analyses, the definitive cure rate was 53.3% in the Sb(v) 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 Sb(v) 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 Sb(v) 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 Sb(v) group.This study demonstrates that miltefosine therapy is more effective than standard Sb(v) and safe for the treatment of CL caused by Leishmania braziliensis in Bahia, Brazil.Clinicaltrials.gov Identifier NCT00600548. |
format |
Article in Journal/Newspaper |
author |
Paulo R Machado Julia Ampuero Luiz H Guimarães Leonardo Villasboas Ana T Rocha Albert Schriefer Rosana S Sousa Anette Talhari Gerson Penna Edgar M Carvalho |
author_facet |
Paulo R Machado Julia Ampuero Luiz H Guimarães Leonardo Villasboas Ana T Rocha Albert Schriefer Rosana S Sousa Anette Talhari Gerson Penna Edgar M Carvalho |
author_sort |
Paulo R Machado |
title |
Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial. |
title_short |
Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial. |
title_full |
Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial. |
title_fullStr |
Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial. |
title_full_unstemmed |
Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial. |
title_sort |
miltefosine in the treatment of cutaneous leishmaniasis caused by leishmania braziliensis in brazil: a randomized and controlled trial. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2010 |
url |
https://doi.org/10.1371/journal.pntd.0000912 https://doaj.org/article/fed5a58e5fb04ecead71ad89bc5a3d97 |
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Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
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PLoS Neglected Tropical Diseases, Vol 4, Iss 12, p e912 (2010) |
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http://europepmc.org/articles/PMC3006132?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0000912 https://doaj.org/article/fed5a58e5fb04ecead71ad89bc5a3d97 |
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https://doi.org/10.1371/journal.pntd.0000912 |
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PLoS Neglected Tropical Diseases |
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12 |
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e912 |
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