Volume 84, Issue 2
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645



Miltefosine has been used in the treatment of several new world cutaneous leishmaniasis (CL) species with variable efficacy. Our study is the first evidence on its clinical efficacy in () . In this phase II/III randomized clinical trial, 90 CL patients were randomly allocated (2:1) to oral miltefosine (2.5 mg/kg/day/28 days) ( = 60) or parenteral antimony (15–20 mg/Sb/kg/day/20 days) ( = 30) according to age groups: 2–12 y/o and 13–65 y/o. Patients were human immunodeficiency virus (HIV) noninfected parasitological proven CL without previous treatment. Definitive cure was accessed at 6 months follow-up visit. No severe adverse events occurred. Vomiting was the most frequent adverse event (48.3%) followed by nausea (8.6%) and diarrhea (6.7%). Cure rates were 71.4% (95% confidence interval [CI] = 57.8–82.7) and 53.6% (95% CI = 33.9–72.5) ( = 0.05) for miltefosine and antimonial, respectively. There were no differences in cure rates between age groups within the same treatment arms. Miltefosine was safe and relatively well tolerated and cure rate was higher than antimony.


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  1. Grimaldi G, Jr Momen H, Naiff RD, McMahon-Pratt D, , 1991. Characterization and classification of leishmanial parasites from humans, wild mammals, and sand flies in the Amazon region of Brazil. Am J Trop Med Hyg 44: 645661. [Google Scholar]
  2. Lainson R, Shaw JJ, Silveira FT, de Souza AA, Braga RR, Ishikawa EA, , 1994. The dermal leishmaniases of Brazil, with special reference to the ecoepidemiology of the disease in Amazonia. Mem Inst Oswaldo Cruz 89: 435443.[Crossref] [Google Scholar]
  3. Ministério da Saúde, Fundação Nacional de Saúde, Centro Nacional de Epidemiologia, , (Brazil), 2007. Manual de Vigilância da Leishmaniose Tegumentar Americana. Second edition. Brasília: Ministério da Saúde. Available at: http://portal.saude.gov.br/portal/arquivos/pdf/manual_lta_2ed.pdf. Accessed May 11, 2010. [Google Scholar]
  4. Sundar S, Jha TK, Thakur CP, Bhattacharya SK, Rai M, , 2006. Oral miltefosine for the treatment of Indian visceral leishmaniasis. Trans R Soc Trop Med Hyg 100 (Suppl 1): S26S33.[Crossref] [Google Scholar]
  5. Soto J, Berman J, , 2006. Treatment of New World cutaneous leishmaniasis with miltefosine. Trans R Soc Trop Med Hyg 100 (Suppl 1): S3440.[Crossref] [Google Scholar]
  6. Soto J, Toledo J, Gutierrez P, Nicholls RS, Padilla J, Engel J, Fischer C, Voss A, Berman JD, , 2001. Treatment of American cutaneous leishmaniasis with miltefosine, an oral agent. Clin Infect Dis 33: 5761.[Crossref] [Google Scholar]
  7. Soto J, Arana BA, Toledo J, Rizzo N, Vega JC, Diaz A, Luz M, Gutierrez P, Arboleda M, Berman JD, Junge K, Engel J, Sindermann H, , 2004. Miltefosine for new world cutaneous leishmaniasis. Clin Infect Dis 38: 12661272.[Crossref] [Google Scholar]
  8. Soto J, Toledo J, Valda L, Balderrama M, Rea I, Parra R, Ardiles J, Soto P, Gomez A, Molleda F, Fuentelsaz C, Anders G, Sindermann H, Engel J, Berman JD, , 2007. Treatment of Bolivian mucosal leishmaniasis with miltefosine. Clin Infec Dis 44: 350356.[Crossref] [Google Scholar]
  9. Soto J, Rea J, Balderrama M, Toledo J, Soto P, Valda L, Berman JD, , 2008. Efficacy of miltefosine for Bolivian cutaneous leishmaniasis. Am J Trop Med Hyg 78: 210211. [Google Scholar]
  10. Arevalo J, Ramirez L, Adaui V, Zimic M, Tulliano G, Miranda-Verástegui C, Lazo M, Loayza-Muro R, De Doncker S, Maurer A, Chappuis F, Dujardin JC, Llanos-Cuentas A, , 2007. Influence of Leishmania (Viannia) species on the response to antimonial treatment in patients with American tegumentary leishmaniasis. J Infect Dis 195: 18461851.[Crossref] [Google Scholar]
  11. Llanos-Cuentas A, Tulliano G, Araujo-Castillo R, Miranda-Verastegui C, Santamaria-Castrellon G, Ramirez L, Lazo M, De Doncker S, Boelaert M, Robays J, Dujardin JC, Arevalo J, Chappuis F, , 2008. Clinical and parasite species risk factors for pentavalent antimonial treatment failure in cutaneous leishmaniasis in Peru. Clin Infect Dis 46: 223231.[Crossref] [Google Scholar]
  12. Saldanha AC, Romero GA, Merchan-Hamann E, Magalhães VA, Macedo VO, , 1999. Comparative study between sodium stibogluconate BP 88 and meglumina antimoniate for cutaneous leishmaniasis treatment: I. Efficacy and safety. Rev Soc Bras Med Trop 32: 383387.[Crossref] [Google Scholar]
  13. Deps PD, Viana MC, Falqueto A, Dietze R, , 2000. Evaluation of the efficacy and toxicity of N-methyl-glucamine vs. BP88 sodium stibogluconate in the treatment of localized cutaneous leishmaniasis. Rev Soc Bras Med Trop 33: 535543.[Crossref] [Google Scholar]
  14. Romero GA, Guerra MV, Paes MG, Macedo VO, , 2001. Comparison of cutaneous leishmaniasis due to Leishmania (Viannia) braziliensis and L. (V.) guyanensis in Brazil: therapeutic response to meglumine antimoniate. Am J Trop Med Hyg 65: 456465. [Google Scholar]
  15. Garcia L, Kindt A, Bermudez H, Llanos-Cuentas A, De Doncker S, Arevalo J, Tintaya KW, Dujardin JC, , 2004. Culture-independent species typing of neotropical Leishmania for clinical validation of a PCR-based assay targeting heat shock protein 70 genes. J Clin Microbiol 42: 22942297.[Crossref] [Google Scholar]
  16. Berman J, , 2003. Current treatment approaches to leishmaniasis. Curr Opin Infect Dis 16: 397401.[Crossref] [Google Scholar]
  17. Rotureau B, Ravel C, Nacher M, Couppie P, Curtet I, Dedet JP, Carme B, , 2006. Molecular epidemiology of Leishmania (Viannia) guyanensis in French Guiana. J Clin Microbiol 44: 468473.[Crossref] [Google Scholar]
  18. Romero GA, Ishikawa E, Cupolillo E, Toaldo CB, Guerra MV, Paes MG, Macedo VO, Shaw JJ, , 2002. Identification of antigenically distinct populations of Leishmania (Viannia) guyanensis from Manaus, Brazil, using monoclonal antibodies. Acta Trop 82: 2529.[Crossref] [Google Scholar]
  19. McMahon-Pratt D, Bennett E, David JR, , 1982. Monoclonal antibodies that distinguish subspecies of Leishmania braziliensis . J Immunol 129: 926927. [Google Scholar]

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  • Received : 11 Mar 2010
  • Accepted : 02 Nov 2010
  • Published online : 04 Feb 2011

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