Pharmacokinetics of miltefosine in old world cutaneous leishmaniasis patients

Antimicrobial Agents and Chemotherapy

Volumn 52, Issue 8, 2008, Pages 2855-2860

  Dorlo, Thomas P C ^a,b   Van Thiel, Pieter P A M ^b,c   Huitema, Alwin D R ^a   Keizer, Ron J ^a   De Vries, Henry J C ^b   Beijnen, Jos H ^a   De Vries, Peter J ^b  

^a NETHERLANDS CANCER INSTITUTE   (Netherlands)

^b ACADEMIC MEDICAL CENTER   (Netherlands)

^c Military Health Care Expertise Coordination Centre   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

MILTEFOSINE; STIBOGLUCONATE SODIUM;

ADULT; AFGHANISTAN; ARTICLE; BLOOD ANALYSIS; BLOOD SAMPLING; CLINICAL ARTICLE; CLINICAL TRIAL; COMPARTMENT MODEL; CONCENTRATION RESPONSE; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG HALF LIFE; FATIGUE; FEMALE; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HUMAN; LEISHMANIA MAJOR; LIQUID CHROMATOGRAPHY; MALE; MATHEMATICAL MODEL; NAUSEA; NONLINEAR SYSTEM; PRIORITY JOURNAL; SIDE EFFECT; SKIN LEISHMANIASIS; SOLDIER; TANDEM MASS SPECTROMETRY; TREATMENT DURATION; VOMITING;

ADULT; AFGHANISTAN; ANIMALS; ANTIPROTOZOAL AGENTS; CHROMATOGRAPHY, LIQUID; FEMALE; HUMANS; LEISHMANIA MAJOR; LEISHMANIASIS, CUTANEOUS; MALE; MASS SPECTROMETRY; METABOLIC CLEARANCE RATE; MILITARY PERSONNEL; MODELS, BIOLOGICAL; NETHERLANDS; PHOSPHORYLCHOLINE; YOUNG ADULT;

EID: 48749114756     PISSN: 00664804     EISSN: None     Source Type: Journal    
DOI: 10.1128/AAC.00014-08     Document Type: Article

References (32)

1. Beal, S. L., and L. B. Sheiner. 1999. NONMEM user's guides. University of California, San Francisco.
2. Berman, J. 2005. Miltefosine to treat leishmaniasis. Expert Opin. Pharmacother. 6:1381-1388.
3. Berman, J., A. D. M. Bryceson, S. Croft, J. Engel, W. Gutteridge, J. Karbwang, H. Sindermann, J. Soto, S. Sundar, and J. A. Urbina. 2006. Miltefosine: issues to be addressed in the future. Trans. R. Soc. Trop. Med. Hyg. 100(Suppl. 1):S41-S44.
4. Bhattacharya, S. K., T. K. Jha, S. Sundar, C. P. Thakur, J. Engel, H. Sindermann, K. Junge, J. Karbwang, A. D. Bryceson, and J. D. Berman. 2004. Efficacy and tolerability of miltefosine for childhood visceral leishmaniasis in India. Clin. Infect. Dis. 38:217-221.
5. Bhattacharya, S. K., P. K. Sinha, S. Sundar, C. P. Thakur, T. K. Jha, K. Pandey, V. R. Das, N. Kumar, C. Lal, N. Verma, V. P. Singh, A. Ranjan, R. B. Verma, G. Anders, H. Sindermann, and N. K. Ganguly. 2007. Phase 4 trial of miltefosine for the treatment of Indian visceral leishmaniasis. J. Infect. Dis. 196:591-598.
6. Bryceson, A. 2001. A policy for leishmaniasis with respect to the prevention and control of drug resistance. Trop. Med. Int. Health 6:928-934.
7. Centers for Disease Control and Prevention (CDC). 2004. Update: cutaneous leishmaniasis in U.S. military personnel - Southwest/Central Asia, 2002-2004. Morb. Mortal. Wkly. Rep. 53:264-265.
8. de Vries, P. J., W. F. van der Meide, M. H. Godfried, H. D. F. H. Schallig, H. J. Dinant, and W. R. Faber. 2006. Quantification of the response to miltefosine treatment for visceral leishmaniasis by QT-NASBA. Trans. R. Soc. Trop. Med. Hyg. 100:1183-1186.
9. Dorlo, T. P. C., M. J. X. Hillebrand, H. Rosing, T. A. Eggelte, P. J. de Vries, and J. H. Beijnen. 2008. Development and validation of a quantitative assay for the measurement of miltefosine in human plasma by liquid chromatography-tandem mass spectrometry. J. Chromatogr. B 865:55-62.
10. Escobar, P., S. Matu, C. Marques, and S. L. Croft. 2002. Sensitivities of Leishmania species to hexadecylphosphocholine (miltefosine), ET-18-OCH(3) (edelfosine) and amphotericin B. Acta Trop. 81:151-157.
11. Herwaldt, B. L. 1999. Leishmaniasis. Lancet 354:1191-1199.
12. Hooker, A. C., C. E. Staatz, and M. O. Karlsson. 2007. Conditional weighted residuals (CWRES): a model diagnostic for the FOCE method. Pharm. Res. 24:2187-2197.
13. Jha, T. K., S. Sundar, C. P. Thakur, P. Bachmann, J. Karbwang, C. Fischer, A. Voss, and J. Berman. 1999. Miltefosine, an oral agent, for the treatment of Indian visceral leishmaniasis. N. Engl. J. Med. 341:1795-1800.
14. Jonsson, E. N., and M. O. Karlsson. 1999. Xpose - an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput. Methods Programs Biomed. 58:51-64.
15. Keizer, R. J. 2008. Piraña 1.0 RC1. http://sourceforge.net/ projects/pirana/.
16. Lindbom, L., J. Ribbing, and E. N. Jonsson. 2004. Perl-speaks-NONMEM (PsN) - a Perl module for NONMEM related programming. Comput. Methods Programs Biomed. 75:85-94.
17. Mohebali, M., A. Fotouhi, B. Hooshmand, Z. Zarei, B. Akhoundi, A. Rah nema, A. R. Razaghian, M. J. Kabir, and A. Nadim. 2007. Comparison of miltefosine and meglumine antimoniate for the treatment of zoonotic cutaneous leishmaniasis (ZCL) by a randomized clinical trial in Iran. Acta Trop. 103:33-40.
18. Perez-Victoria, F. J., M. P. Sanchez-Canete, K. Seifert, S. L. Croft, S. Sundar, S. Castanys, and F. Gamarro. 2006. Mechanisms of experimental resistance of Leishmania to miltefosine: implications for clinical use. Drug Resist. Updat. 9:26-39.
19. Seifert, K., S. Matu, F. Javier Perez-Victoria, S. Castanys, F. Gamarro, and S. L. Croft. 2003. Characterisation of Leishmania donovani promastigotes resistant to hexadecylphosphocholine (miltefosine). Int. J. Antimicrob. Agents 22:380-387.
20. Sindermann, H., and J. Engel. 2006. Development of miltefosine as an oral treatment for leishmaniasis. Trans. R. Soc. Trop. Med. Hyg. 100(Suppl. 1):S17-S20.
21. Soto, J., B. A. Arana, J. Toledo, N. Rizzo, J. C. Vega, A. Diaz, M. Luz, P. Gutierrez, M. Arboleda, J. D. Berman, K. Junge, J. Engel, and H. Sindermann. 2004. Miltefosine for new world cutaneous leishmaniasis. Clin. Infect. Dis. 38:1266-1272.
22. Soto, J., J. Toledo, P. Gutierrez, R. S. Nicholls, J. Padilla, J. Engel, C. Fischer, A. Voss, and J. Berman. 2001. Treatment of American cutaneous leishmaniasis with miltefosine, an oral agent. Clin. Infect. Dis. 33:E57-E61.
23. Soto, J., J. Toledo, L. Valda, M. Balderrama, I. Rea, R. Parra, J. Ardiles, P. Soto, A. Gomez, F. Molleda, C. Fuentelsaz, G. Anders, H. Sindermann, J. Engel, and J. Berman. 2007. Treatment of Bolivian mucosal leishmaniasis with miltefosine. Clin. Infect. Dis. 44:350-356.
24. Stojkovic, M., T. Junghanss, E. Krause, and R. N. Davidson. 2007. First case of typical Old World cutaneous leishmaniasis treated with miltefosine. Int. J. Dermatol. 46:385-387.
25. Sundar, S. 2001. Drug resistance in Indian visceral leishmaniasis. Trop. Med. Int. Health 6:849-854.
26. Sundar, S., T. K. Jha, H. Sindermann, K. Junge, P. Bachmann, and J. Berman. 2003. Oral miltefosine treatment in children with mild to moderate Indian visceral leishmaniasis. Pediatr. Infect. Dis. J. 22:434-438.
27. Sundar, S., T. K. Jha, C. P. Thakur, J. Engel, H. Sindermann, C. Fischer, K. Junge, A. Bryceson, and J. Berman. 2002. Oral miltefosine for Indian visceral leishmaniasis. N. Engl. J. Med. 347:1739-1746.
28. Sundar, S., D. K. More, M. K. Singh, V. P. Singh, S. Sharma, A. Makharia, P. C. Kumar, and H. W. Murray. 2000. Failure of pentavalent antimony in visceral leishmaniasis in India: report from the center of the Indian epidemic. Clin. Infect. Dis. 31:1104-1107.
29. Sundar, S., and H. W. Murray. 2005. Availability of miltefosine for the treatment of kala-azar in India. Bull. W.H.O. 83:394-395.
30. Sundar, S., F. Rosenkaimer, M. K. Makharia, A. K. Goyal, A. K. Mandal, A. Voss, P. Hilgard, and H. W. Murray. 1998. Trial of oral miltefosine for visceral leishmaniasis. Lancet 352:1821-1823.
31. van der Meide, W. F., G. J. Schoone, W. R. Faber, J. E. Zeegelaar, H. J. C. de Vries, Y. Ozbel, A. F. Lai, L. I. A. R. Coelho, M. Kassi, and H. D. F. H. Schallig. 2005. Quantitative nucleic acid sequence-based assay as a new molecular tool for detection and quantification of Leishmania parasites in skin biopsy samples. J. Clin. Microbiol. 43:5560-5566.
32. Weina, P. J., R. C. Neafie, G. Wortmann, M. Polhemus, and N. E. Aronson. 2004. Old World leishmaniasis: an emerging infection among deployed US military and civilian workers. Clin. Infect. Dis. 39:1674-1680.