{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T04:08:35Z","timestamp":1790050115794,"version":"4.0.1"},"reference-count":37,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2010,8,5]]},"abstract":"<jats:p>Miltefosine is an oral agent used for cutaneous leishmaniasis treatment. An open-label, randomized, phase III clinical trial was carried out in the Colombian army population. Miltefosine, 50 mg capsule was taken orally three times per day for 28 days (<jats:italic>N<\/jats:italic> = 145) or meglumine antimoniate, 20 mg\/kg body weight per day for 20 days by intramuscular injection (<jats:italic>N<\/jats:italic> = 143). The efficacy of miltefosine by protocol was 69.8% (85\/122 patients) and 58.6% (85\/145 patients) by intention to treat. For meglumine antimoniate, the efficacy by protocol was 85.1% (103\/121 patients) and 72% (103\/143 patients) by intention to treat. No association was found between drug efficacy and <jats:italic>L. (<jats:italic>V.<\/jats:italic>) braziliensis<\/jats:italic> or <jats:italic>L.<\/jats:italic> (<jats:italic>V.<\/jats:italic>) <jats:italic>panamensis<\/jats:italic> species of <jats:italic>Leishmania<\/jats:italic> responsible for infection. Adverse gastrointestinal events were associated with the use of miltefosine, the meglumine antimoniate treatment was associated with adverse effects on the skeletal musculature, fever, cephalea, and higher toxicity in kidney, liver, pancreas, and hematological system.<\/jats:p>","DOI":"10.4269\/ajtmh.2010.10-0060","type":"journal-article","created":{"date-parts":[[2010,8,3]],"date-time":"2010-08-03T19:18:56Z","timestamp":1280863136000},"page":"351-356","source":"Crossref","is-referenced-by-count":84,"title":["Efficacy of Miltefosine for the Treatment of American Cutaneous Leishmaniasis"],"prefix":"10.4269","volume":"83","author":[{"given":"Iv\u00e1n","family":"V\u00e9lez","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liliana","family":"L\u00f3pez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ximena","family":"S\u00e1nchez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laureano","family":"Mestra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos","family":"Rojas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erwin","family":"Rodr\u00edguez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2795","reference":[{"key":"R1","series-title":"J Dtsch Dermatol Ges","first-page":"754","article-title":"Leishmaniasis","volume":"6","author":"Neuber","year":"2008"},{"key":"R2","series-title":"Cochrane Database Syst Rev","first-page":"CD004834","article-title":"Interventions for American cutaneous and mucocutaneous leishmaniasis","author":"Gonzalez","year":"2009"},{"key":"R3","series-title":"Trends Parasitol","first-page":"552","article-title":"Leishmaniasis and poverty","volume":"22","author":"Alvar","year":"2006"},{"key":"R4","series-title":"Clin Dermatol","first-page":"203","article-title":"Cutaneous leishmaniasis","volume":"25","author":"Bailey","year":"2007"},{"issue":"(Suppl 1)","key":"R5","series-title":"Biomedica (Bogota)","first-page":"194","article-title":"Current situation and future of antileishmanial therapy in Colombia","volume":"26","author":"Soto","year":"2006"},{"key":"R6","series-title":"Curr Med Chem","first-page":"599","article-title":"Leishmaniasis: current treatment and prospects for new drugs and vaccines","volume":"16","author":"Kedzierski","year":"2009"},{"key":"R7","series-title":"Lancet","first-page":"1561","article-title":"Advances in leishmaniasis","volume":"366","author":"Murray","year":"2005"},{"key":"R8","series-title":"Drug Resist Updat","first-page":"257","article-title":"Leishmaniasis: drugs in the clinic, resistance and new developments","volume":"7","author":"Ouellette","year":"2004"},{"key":"R9","series-title":"Am J Ther","first-page":"178","article-title":"Current treatment for cutaneous leishmaniasis: a review","volume":"16","author":"Palumbo","year":"2009"},{"key":"R10","series-title":"Clin Infect Dis","first-page":"1549","article-title":"Role of imiquimod and parenteral meglumine antimoniate in the initial treatment of cutaneous leishmaniasis","volume":"44","author":"Arevalo","year":"2007"},{"key":"R11","series-title":"Clin Dermatol","first-page":"519","article-title":"Treatment of New World cutaneous and mucosal leishmaniases","volume":"14","author":"Berman","year":"1996"},{"key":"R12","series-title":"Rev Soc Bras Med Trop","first-page":"457","article-title":"The evaluation of the tolerance and nephrotoxicity of pentavalent antimony administered in a dose of 40 mg Sb V\/kg\/day, 12\/12 hr, for 30 days in the mucocutaneous form of leishmaniasis","volume":"30","author":"Sampaio","year":"1997"},{"key":"R13","series-title":"J Infect Dis","first-page":"1793","article-title":"Antimony plus recombinant human granulocyte-macrophage colony-stimulating factor applied topically in low doses enhances healing of cutaneous Leishmaniasis ulcers: a randomized, double-blind, placebo-controlled study","volume":"190","author":"Santos","year":"2004"},{"key":"R14","series-title":"QJM","first-page":"659","article-title":"Out-patient parenteral antimicrobial therapy\u2014a viable option for the management of cutaneous leishmaniasis","volume":"92","author":"Seaton","year":"1999"},{"key":"R15","series-title":"Lancet","first-page":"498","article-title":"Treatment of cutaneous leishmaniasis in Colombia with dapsone","volume":"351","author":"Osorio","year":"1998"},{"key":"R16","series-title":"J Dermatolog Treat","first-page":"26","article-title":"Treatment of cutaneous leishmaniasis with ketoconazole cream","volume":"14","author":"Momeni","year":"2003"},{"key":"R17","series-title":"Int J Dermatol","first-page":"120","article-title":"Failure of ketoconazole treatment in cutaneous leishmaniasis","volume":"34","author":"Singh","year":"1995"},{"key":"R18","series-title":"Am J Trop Med Hyg","first-page":"889","article-title":"Lack of efficacy of mefloquine in the treatment of New World cutaneous leishmaniasis in Colombia","volume":"59","author":"Hendrickx","year":"1998"},{"key":"R19","series-title":"Ann Intern Med","first-page":"232","article-title":"Inefficacy of allopurinol as monotherapy for Colombian cutaneous leishmaniasis. A randomized, controlled trial","volume":"126","author":"Velez","year":"1997"},{"key":"R20","series-title":"J Coll Physicians Surg Pak","first-page":"471","article-title":"A therapeutic update on cutaneous leishmaniasis","volume":"13","author":"Bari","year":"2003"},{"issue":"(Suppl 1)","key":"R21","series-title":"Trans R Soc Trop Med Hyg","first-page":"S4","article-title":"Miltefosine\u2013discovery of the antileishmanial activity of phospholipid derivatives","volume":"100","author":"Croft","year":"2006"},{"key":"R22","series-title":"J Antimicrob Chemother","first-page":"1041","article-title":"The activities of four anticancer alkyllysophospholipids against Leishmania donovani, Trypanosoma cruzi and Trypanosoma brucei","volume":"38","author":"Croft","year":"1996"},{"key":"R23","series-title":"Acta Trop","first-page":"151","article-title":"Sensitivities of Leishmania species to hexadecylphosphocholine (miltefosine), ET-18-OCH(3) (edelfosine) and amphotericin B","volume":"81","author":"Escobar","year":"2002"},{"key":"R24","series-title":"Antimicrob Agents Chemother","first-page":"4950","article-title":"Efficacy of orally administered 2-substituted quinolines in experimental murine cutaneous and visceral leishmaniases","volume":"49","author":"Nakayama","year":"2005"},{"key":"R25","series-title":"Am J Trop Med Hyg","first-page":"272","article-title":"The sensitivity of clinical isolates of Leishmania from Peru and Nepal to miltefosine","volume":"73","author":"Yardley","year":"2005"},{"key":"R26","series-title":"Antimicrob Agents Chemother","first-page":"1872","article-title":"Activities of hexadecylphosphocholine (miltefosine), AmBisome, and sodium stibogluconate (Pentostam) against Leishmania donovani in immunodeficient scid mice","volume":"45","author":"Escobar","year":"2001"},{"key":"R27","series-title":"N Engl J Med","first-page":"1739","article-title":"Oral miltefosine for Indian visceral leishmaniasis","volume":"347","author":"Sundar","year":"2002"},{"key":"R28","series-title":"Lancet","first-page":"1821","article-title":"Trial of oral miltefosine for visceral leishmaniasis","volume":"352","author":"Sundar","year":"1998"},{"key":"R29","series-title":"Clin Infect Dis","first-page":"1266","article-title":"Miltefosine for new world cutaneous leishmaniasis","volume":"38","author":"Soto","year":"2004"},{"key":"R30","series-title":"Clin Infect Dis","first-page":"E57","article-title":"Treatment of American cutaneous leishmaniasis with miltefosine, an oral agent","volume":"33","author":"Soto","year":"2001"},{"key":"R31","series-title":"Leishmaniosis Manual de Procedimientos para el Diagn\u00f3stico de la Leishmaniosis Cut\u00e1nea Americana Medell\u00edn","first-page":"13","author":"Velez","year":"1996"},{"key":"R32","series-title":"Expert Rev Mol Diagn","first-page":"251","article-title":"Applications of molecular methods for Leishmania control","volume":"5","author":"Singh","year":"2005"},{"key":"R33","series-title":"Semin Radiat Oncol","first-page":"176","article-title":"CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment","volume":"13","author":"Trotti","year":"2003"},{"key":"R34","series-title":"Cad Saude Publica","first-page":"171","article-title":"Gender and cutaneous leishmaniasis in Colombia","volume":"17","author":"Velez","year":"2001"},{"key":"R35","series-title":"Am J Trop Med Hyg","first-page":"210","article-title":"Efficacy of miltefosine for Bolivian cutaneous leishmaniasis","volume":"78","author":"Soto","year":"2008"},{"key":"R36","series-title":"Clin Infect Dis","first-page":"350","article-title":"Treatment of Bolivian mucosal leishmaniasis with miltefosine","volume":"44","author":"Soto","year":"2007"},{"issue":"(Suppl 1)","key":"R37","series-title":"Biomedica (Bogota)","first-page":"13","article-title":"Miltefosine for disseminated cutaneous leishmaniasis","volume":"26","author":"Gonzalez","year":"2006"}],"container-title":["The American Society of Tropical Medicine and Hygiene"],"original-title":[],"link":[{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/83\/2\/article-p351.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.ajtmh.org\/downloadpdf\/journals\/tpmd\/83\/2\/article-p351.xml","content-type":"text\/html","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/www.ajtmh.org\/downloadpdf\/journals\/tpmd\/83\/2\/article-p351.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,9,2]],"date-time":"2024-09-02T16:01:15Z","timestamp":1725292875000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/83\/2\/article-p351.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2010,8,5]]},"references-count":37,"journal-issue":{"issue":"2"},"URL":"https:\/\/doi.org\/10.4269\/ajtmh.2010.10-0060","relation":{},"ISSN":["0002-9637","1476-1645"],"issn-type":[{"value":"0002-9637","type":"print"},{"value":"1476-1645","type":"electronic"}],"subject":[],"published":{"date-parts":[[2010,8,5]]}}}