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Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial

Machado, Paulo R ; Ampuero, Julia ; Guimarães, Luiz H ; Villasboas, Leonardo ; Rocha, Ana T ; Schriefer, Albert ; Sousa, Rosana S ; Talhari, Anette ; Penna, Gerson ; Carvalho, Edgar M Buffet, Pierre

PLoS neglected tropical diseases, 2010-12, Vol.4 (12), p.e912 [Peer Reviewed Journal]

United States: Public Library of Science

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Title:
Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial
Author: Machado, Paulo R ; Ampuero, Julia ; Guimarães, Luiz H ; Villasboas, Leonardo ; Rocha, Ana T ; Schriefer, Albert ; Sousa, Rosana S ; Talhari, Anette ; Penna, Gerson ; Carvalho, Edgar M
Buffet, Pierre
Subjects: Abdominal Pain - chemically induced ; Administration, Oral ; Adolescent ; Adult ; Aged ; Antimony - administration & dosage ; Antiprotozoal Agents - administration & dosage ; Antiprotozoal Agents - adverse effects ; Brazil ; Child ; Child, Preschool ; Clinical trials ; Dermatology/Skin Infections ; Drug therapy ; Female ; Humans ; Infectious Diseases/Neglected Tropical Diseases ; Infectious Diseases/Protozoal Infections ; Infectious Diseases/Skin Infections ; Leishmania braziliensis - drug effects ; Leishmania braziliensis - isolation & purification ; Leishmaniasis, Cutaneous - drug therapy ; Male ; Middle Aged ; Nausea - chemically induced ; Parasitic diseases ; Phosphorylcholine - administration & dosage ; Phosphorylcholine - adverse effects ; Phosphorylcholine - analogs & derivatives ; Population ; Prevalence ; Rural areas ; Treatment Outcome ; Tropical diseases ; Vomiting - chemically induced ; Young Adult
Is Part Of: PLoS neglected tropical diseases, 2010-12, Vol.4 (12), p.e912
Notes: Conceived and designed the experiments: PRM AT GP EMC. Performed the experiments: PRM JA LHG LV. Analyzed the data: ATR. Contributed reagents/materials/analysis tools: JA AS RSS. Wrote the paper: PRM EMC. Assignment of interventions: PRM. Collected the data: PRM JA. Evaluated clinical outcome: LHG EMC.
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.
Publisher: United States: Public Library of Science
Language: English

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Miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil: a randomized and controlled trial

Machado, Paulo R ; Ampuero, Julia ; Guimarães, Luiz H ; Villasboas, Leonardo ; Rocha, Ana T ; Schriefer, Albert ; Sousa, Rosana S ; Talhari, Anette ; Penna, Gerson ; Carvalho, Edgar M Buffet, Pierre

United States: Public Library of Science

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