Safety and efficacy of miltefosine monotherapy and pentoxifylline associated with pentavalent antimony in treating mucosal leishmaniasis

References

• Marsden PD. Mucosal leishmaniasis. Trans R Soc Trop Med Hyg. 1986;80:859–876.
   PubMed Web of Science ®Google Scholar
• Aronson N, Herwaldt BL, Libman M, et al. Diagnosis and treatment of leishmaniasis: clinical practice guidelines by the Infectious Diseases Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH). Clin Infect Dis. 2016 Dec 15;63(12):e202–e264.
   PubMed Web of Science ®Google Scholar
• Franke ED, Wignall FS, Cruz ME, et al. Efficacy and toxicity of sodium stibogluconate for mucosal leishmaniasis. Ann Intern Med. 1990;113:934–940.
   PubMed Web of Science ®Google Scholar
• Netto EM, Marsden PD, Llanos-Cuentas EA, et al. Long-term follow-up of patients with Leishmania (Viannia) braziliensis infection and treated with glucantime. Trans R Soc Trop Med Hyg. 1990;84:367–370.
   PubMed Web of Science ®Google Scholar
• Sundar S, Jha TK, Thakur CP, et al. Oral miltefosine for Indian visceral leishmaniasis. N Engl J Med. 2002;347:1739–1746.
   PubMed Web of Science ®Google Scholar
• Machado PR, Penna G. Miltefosine and cutaneous leishmaniasis. Curr Opin Infect Dis. 2012 Apr;25(2):141–144.
   PubMed Web of Science ®Google Scholar
• Bacellar O, Lessa H, Schriefer A, et al. Up-regulation of Th1-type responses in mucosal leishmaniasis patients. Infect Immun. 2002 Dec;70(12):6734–6740.
   PubMed Web of Science ®Google Scholar
• Jones TC, Johnson WD, Barreto AC, et al. Epidemiology of American cutaneous leishmaniasis due to Leishmania braziliensis braziliensis. J Infect Dis. 1987;156:73–83.
   PubMed Web of Science ®Google Scholar
• Bedoya-Pacheco SJ, Araujo-Melo MH, Valete-Rosalino CM, et al. Endemic tegumentary leishmaniasis in Brazil: correlation between level of endemicity and number of cases of mucosal disease. Am J Trop Med Hyg. 2011 Jun;84(6):901–905.
   PubMed Web of Science ®Google Scholar
• Murray HW, Berman JD, Davies CR, et al. Advances in leishmaniasis. Lancet. 2005;366:1561–1577.
   PubMed Web of Science ®Google Scholar
• Guerra JA, Prestes SR, Silveira H, et al. Mucosal leishmaniasis caused by Leishmania (Viannia) braziliensis and Leishmania (Viannia) guyanensis in the Brazilian Amazon. PLoS Negl Trop Dis. 2011 Mar 8;5(3):e980.
   PubMed Web of Science ®Google Scholar
• Marsden PD, Llanos-Cuentas EA, Lago EL, et al. Human mucocutaneous leishmaniasis in Três Braços, Bahia- Brazil. An area of Leishmania braziliensis braziliensis transmission. III - Mucosal disease presentation and initial evolution. Rev Soc Bras Med Trop. 1984;17:179–186.
   Google Scholar
• Lessa MM, Lessa HA, Castro TW, et al. Mucosal leishmaniasis: epidemiological and clinical aspects. Braz J Otorhinolaryngol. 2007 Nov–Dec;73(6):843–847.
   PubMedGoogle Scholar
• Jirmanus L, Glesby MJ, Guimarães LH, et al. Epidemiological and clinical changes in American tegumentary leishmaniasis in an area of Leishmania (Viannia) braziliensis transmission over a 20-year period. Am J Trop Med Hyg. 2012 Mar;86(3):426–433.
   PubMed Web of Science ®Google Scholar
• Cincurá C, De Lima CMF, Machado PRL, et al. Mucosal leishmaniasis: a retrospective study of 327 cases from an endemic area of Leishmania (Viannia) braziliensis. Am J Trop Med Hyg. 2017 Sep;97(3):761–766.
   PubMed Web of Science ®Google Scholar
• da Costa DC, Palmeiro MR, Moreira JS, et al. Oral manifestations in the American tegumentary leishmaniasis. PLoS One. 2014 Nov 11;9(11):e109790.
   PubMed Web of Science ®Google Scholar
• Lessa HA, Lessa MM, Guimarães LH, et al. A proposed new clinical staging system for patients with mucosal leishmaniasis. Trans R Soc Trop Med Hyg. 2012 Jun;106(6):376–381.
   PubMed Web of Science ®Google Scholar
• Machado PR, Lessa H, Lessa M, et al. Oral pentoxifylline combined with pentavalent antimony: a randomized trial for mucosal leishmaniasis. Clin Infect Dis. 2007;44(6):788–793.
   PubMed Web of Science ®Google Scholar
• Lux H, Heise N, Klenner T, et al. Ether-lipid (alkylphospholipid) metabolism and the mechanism of action of ether-lipid analogues in Leishmania. Mol Biochem Parasitol. 2000;111:1–14.
   PubMed Web of Science ®Google Scholar
• Urbina JA. Lipid biosynthesis pathways as chemotherapeutic targets in kinetoplastid parasites. Parasitology. 1997;114:91–99.
   PubMed Web of Science ®Google Scholar
• Croft SL, Neal RA, Pendergast W, et al. The activity of alkyl phosphorylcholines and related derivatives against Leishmania donovani. Biochem Pharmacol. 1987;36:2633–2636.
   PubMed Web of Science ®Google Scholar
• Espada CR, Ribeiro-Dias F, Dorta ML, et al. Susceptibility to miltefosine in Brazilian clinical isolates of Leishmania (viannia) braziliensis. Am J Trop Med Hyg. 2017;96(3):656–659.
   PubMed Web of Science ®Google Scholar
• Kuhlencord A, Maniera T, Eibl H, et al. Hexadecylphosphocholine: oral treatment of visceral leishmaniasis in mice. Antimicrob Agents Chemother. 1992;36:1630–1634.
   PubMed Web of Science ®Google Scholar
• Bustos MFG, Barrio A, Prieto GG, et al. In vivo antileishmanial efficacy of miltefosine against Leishmania (leishmania) amazonensis. J Parasitol. 2014;100(6):840–847.
   PubMed Web of Science ®Google Scholar
• [cited 2017 Nov 25]. Available from: http://www.who.int/leishmaniasis/research/978924129496_pp67_71.pdf?ua=1
   Google Scholar
• Soto J, Toledo J, Gutierrez P, et al. Treatment of American cutaneous leishmaniasis with miltefosine, an oral agent. Clin Infect Dis. 2001;33:57–61.
   PubMedGoogle Scholar
• Soto J, Arana BA, Toledo J, et al. Miltefosine for new world cutaneous leishmaniasis. Clin Infect Dis. 2004;38:1266–1272.
   PubMed Web of Science ®Google Scholar
• Soto J, Rea J, Balderrama M, et al. Efficacy of miltefosine for Bolivian cutaneous leishmaniasis. Am J Trop Med Hyg. 2008;78:210–211.
   PubMed Web of Science ®Google Scholar
• Machado PR, Lessa H, Lessa M, et al. Oral pentoxifylline combined with pentavalent antimony: a randomized trial for mucosal leishmaniasis. Clin Infect Dis. 2007 Mar 15;44(6):788–793.
   PubMed Web of Science ®Google Scholar
• Chrusciak-Talhari A, Dietze R, Chrusciak Talhari C, et al. Randomized controlled clinical trial to access efficacy and safety of miltefosine in the treatment of cutaneous leishmaniasis caused by Leishmania (Viannia) guyanensis in Manaus, Brazil. Am J Trop Med Hyg. 2011 Feb;84(2):255–260.
   PubMed Web of Science ®Google Scholar
• Vélez I, López L, Sánchez X, et al. Efficacy of miltefosine for the treatment of American cutaneous leishmaniasis. Am J Trop Med Hyg. 2010;83(2):351–356.
   PubMed Web of Science ®Google Scholar
• [cited 2017 Nov 25]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204684s000lbl.pdf
   Google Scholar
• Soto J, Toledo J, Valda L, et al. Treatment of Bolivian mucosal leishmaniasis with miltefosine. Clin Infect Dis. 2007;44:350–356.
   PubMed Web of Science ®Google Scholar
• Soto J, Rea J, Valderrama M, et al. Efficacy of extended (six weeks) treatment with miltefosine for mucosal leishmaniasis in Bolivia. Am J Trop Med Hyg. 2009 Sep;81(3):387–389.
   PubMed Web of Science ®Google Scholar
• Garcia Bustos MF, Barrio A, Parodi C, et al. Miltefosine versus meglumine antimoniate in the treatment of mucosal leishmaniasis. Medicina (B Aires). 2014;74(5):371–377.
   PubMed Web of Science ®Google Scholar
• Mosimann V, Blazek C, Grob H, et al. Miltefosine for mucosal and complicated cutaneous Old World Leishmaniasis: a case series and review of the literature. Open Forum Infect Dis. 2016 Feb 1;3(1):ofw008.
   PubMed Web of Science ®Google Scholar
• Samlaska CP, Winfield EA. Pentoxifylline. J Am Acad Dermatol. 1994;30:603–621.
   PubMed Web of Science ®Google Scholar
• Ward A, Clissold SP. Pentoxifylline: a review of its pharmacodynamic and pharmacokinetic properties, and its therapeutic efficacy. Drugs. 1987;34:50–97.
   PubMed Web of Science ®Google Scholar
• Gutierrez-Reyes G, Lopez-Ortal P, Sixtos S, et al. Effect of pentoxifylline on levels of pro-inflammatory cytokines during chronic hepatitis C. Scand J Immunol. 2006;63:461–467.
   PubMed Web of Science ®Google Scholar
• Doherty GM, Jensen JC, Alexander HR, et al. Pentoxifylline suppression of tumor necrosis factor gene transcription. Surgery. 1991;110:192–196.
   PubMed Web of Science ®Google Scholar
• Hoebe KH, Gonzalez-Ramon N, Nijmeijer SM, et al. Differential effects of pentoxifylline on the hepatic inflammatory response in porcine liver cell cultures. Increase in inducible nitric oxide synthase expression. Biochem Pharmacol. 2001 May 1;61(9):1137-1144.
   Google Scholar
• Beshay E, Croze F, Prud’homme GJ. The phosphodiesterase inhibitors pentoxifylline and rolipram suppress macrophage activation and nitric oxide production in vitro and in vivo. Clin Immunol. 2001 Feb;98(2):272–279.
   PubMed Web of Science ®Google Scholar
• Smith RV, Waller ES, Doluisio JT, et al. Pharmacokinetics of orally administered pentoxifylline in humans. J Pharm Sci. 1986;75:47–52.
   PubMed Web of Science ®Google Scholar
• [cited 2017 Nov 25]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018631s039lbl.pdf
   Google Scholar
• Strieter RM, Remick DG, Ward PA, et al. Cellular and molecular regulation of tumor necrosis factor-alpha production by pentoxifylline. Biochem Biophys Res Commun. 1988;155:1230–1236.
   PubMed Web of Science ®Google Scholar
• Sampaio EP, Moraes MO, Nery JA, et al. Pentoxifylline decreases in vivo and in vitro tumour necrosis factor-alpha (TNF-α) production in lepromatous leprosy patients with erythema nodosum leprosum (ENL). Clin Exp Immunol. 1998;111:300–308.
   PubMed Web of Science ®Google Scholar
• Oliveira WN, Ribeiro LE, Schrieffer A, et al. The role of inflammatory and anti-inflammatory cytokines in the pathogenesis of human tegumentary leishmaniasis. Cytokine. 2014;66(2):127–132.
   PubMed Web of Science ®Google Scholar
• D’Oliveira A Jr, Machado P, Bacellar O, et al. Evaluation of IFN-gamma and TNF alpha as immunological markers of clinical outcome in cutaneous leishmaniasis. Rev Soc Bras Med Trop. 2002;35:7–10.
   PubMedGoogle Scholar
• Antonelli LR, Dutra WO, Almeida RP, et al. Activated inflammatory T cells correlate with lesion size in human cutaneous leishmaniasis. Immunol Lett. 2005;101:226–230.
   PubMed Web of Science ®Google Scholar
• Melby PC, Andrade-Narvaez FJ, Darnell BJ, et al. Increased expression of proinflammatory cytokines in chronic lesions of human cutaneous leishmaniasis. Infect Immun. 1994;62:837–842.
   PubMed Web of Science ®Google Scholar
• Santos JB, Jesus AR, Machado PR, et al. 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. J Infect Dis. 2004;190:1793–1796.
   PubMed Web of Science ®Google Scholar
• Almeida RP, Brito J, Machado PL, et al. Successful treatment of refractory cutaneous leishmaniasis with GM-CSF and antimonials. Am J Trop Med Hyg. 2005;73:79–81.
   PubMed Web of Science ®Google Scholar
• Lessa HA, Machado P, Lima F, et al. Successful treatment of refractory mucosal leishmaniasis with pentoxifylline plus antimony. Am J Trop Med Hyg. 2001;65:87–89.
   PubMed Web of Science ®Google Scholar
• Brito G, Dourado M, Polari L, et al. Short report: clinical and immunological outcome in cutaneous leishmaniasis patients treated with pentoxifylline. Am J Trop Med Hyg. 2014;90(4):617–620.
   PubMed Web of Science ®Google Scholar
• Báfica A, Oliveira F, Freitas LA, et al. American cutaneous leishmaniasis unresponsive to antimonial drugs: successful treatment using combination of N-methilglucamine antimoniate plus pentoxifylline. Int J Dermatol. 2003;42:203–207.
   PubMed Web of Science ®Google Scholar
• Sadeghian G, Nilforoushzadeh MA. Effect of combination therapy with systemic glucantime and pentoxifylline in the treatment of cutaneous leishmaniasis. Int J Dermatol. 2006;45:819–821.
   PubMed Web of Science ®Google Scholar
• Lessa HA, Machado P, Lima F, et al. Successful treatment of refractory mucosal leishmaniasis with pentoxifylline plus antimony. Am J Trop Med Hyg. 2001;65:87–89.
   PubMed Web of Science ®Google Scholar
• Brito G, Dourado M, Guimarães LH, et al. Oral pentoxifylline associated with pentavalent antimony: a randomized trial for cutaneous leishmaniasis. Am J Trop Med Hyg. 2017;96:1155–1159.
   PubMed Web of Science ®Google Scholar