Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial.
<h4>Background</h4>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.<h4>Methodology/principal findings</h4&...
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Public Library of Science (PLoS)
2010-12-01
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| Series: | PLoS Neglected Tropical Diseases |
| Online Access: | https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0000912&type=printable |
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| 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 |
| collection | DOAJ |
| description | <h4>Background</h4>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.<h4>Methodology/principal findings</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration</h4>Clinicaltrials.gov Identifier NCT00600548. |
| format | Article |
| id | doaj-art-fed5a58e5fb04ecead71ad89bc5a3d97 |
| institution | DOAJ |
| issn | 1935-2727 1935-2735 |
| language | English |
| publishDate | 2010-12-01 |
| publisher | Public Library of Science (PLoS) |
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| series | PLoS Neglected Tropical Diseases |
| spelling | doaj-art-fed5a58e5fb04ecead71ad89bc5a3d972025-08-20T03:00:51ZengPublic Library of Science (PLoS)PLoS Neglected Tropical Diseases1935-27271935-27352010-12-01412e91210.1371/journal.pntd.0000912Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial.Paulo R MachadoJulia AmpueroLuiz H GuimarãesLeonardo VillasboasAna T RochaAlbert SchrieferRosana S SousaAnette TalhariGerson PennaEdgar M Carvalho<h4>Background</h4>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.<h4>Methodology/principal findings</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration</h4>Clinicaltrials.gov Identifier NCT00600548.https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0000912&type=printable |
| spellingShingle | 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. PLoS Neglected Tropical Diseases |
| title | 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_short | 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 |
| url | https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0000912&type=printable |
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