Population pharmacokinetics of lumefantrine in pregnant and nonpregnant women with uncomplicated plasmodium falciparum malaria in Uganda

CPT: Pharmacometrics and Systems Pharmacology

Volumn 2, Issue 11, 2013, Pages

  Kloprogge, F ^a,b   Piola, P ^b,c,d   Dhorda, M ^c,e   Muwanga, S ^c   Turyakira, E ^c,d   Apinan, S ^a   Lindegardh N ^a,b   Nosten, F ^a,b,f   Day, N P J ^a,b   White, N J ^a,b   Guerin, P J ^b,c   Tarning, J ^a,b  

^a MAHIDOL UNIVERSITY   (Thailand)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c EPICENTRE   (France)

^d MBARARA UNIVERSITY OF SCIENCE AND TECHNOLOGY   (Uganda)

^e University of Maryland School of Medicine Center for Vaccine Development   (United States)

^f SHOKLO MALARIA RESEARCH UNIT   (Thailand)

Author keywords

[No Author keywords available]

Indexed keywords

ARTEMETHER PLUS BENFLUMETOL; BENFLUMETOL;

ADOLESCENT; ADULT; ARTICLE; BODY TEMPERATURE; CONTROLLED STUDY; DEMOGRAPHY; DRUG ABSORPTION; DRUG BLOOD LEVEL; FEMALE; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; MALARIA FALCIPARUM; PARASITEMIA; POPULATION; PREGNANT WOMAN; PRIORITY JOURNAL; SECOND TRIMESTER PREGNANCY; THIRD TRIMESTER PREGNANCY; TREATMENT DURATION; UGANDA; YOUNG ADULT;

EID: 84891794458     PISSN: None     EISSN: 21638306     Source Type: Journal    
DOI: 10.1038/psp.2013.59     Document Type: Article

References (43)

1. WHO. World malaria report 2012. (2012).
2. Dellicour, S., Tatem, A.J., Guerra, C.A., Snow, R.W., ter Kuile, F.O. Quantifying the number of pregnancies at risk of malaria in 2007: a demographic study. PLoS Med. 7, e1000221 (2010).
3. WHO. World Health Organization Guidelines for the treatment of malaria. (2010).
4. Ezzet, F., Mull, R. & Karbwang, J. Population pharmacokinetics and therapeutic response of CGP 56697 (artemether + benflumetol) in malaria patients. Br. J. Clin. Pharmacol. 46, 553-561 (1998). (Pubitemid 28522119)
5. Price, R.N. et al. Molecular and pharmacological determinants of the therapeutic response to artemether-lumefantrine in multidrug-resistant Plasmodium falciparum malaria. Clin. Infect. Dis. 42, 1570-1577 (2006).
6. Krudsood, S. et al. Comparative clinical trial of two-fixed combinations dihydroartemisininnapthoquine-trimethoprim (DNP) and artemether-lumefantrine (Coartem/Riamet) in the treatment of acute uncomplicated falciparum malaria in Thailand. Southeast Asian J. Trop. Med. Public Health 34, 316-321 (2003). (Pubitemid 37141264)
7. Vugt, M.V. et al. Efficacy of six doses of artemether-lumefantrine (benflumetol) in multidrug-resistant Plasmodium falciparum malaria. Am. J. Trop. Med. Hyg. 60, 936-942 (1999).
8. Ashley, E.A. et al. Pharmacokinetic study of artemether-lumefantrine given once daily for the treatment of uncomplicated multidrug-resistant falciparum malaria. Trop. Med. Int. Health 12, 201-208 (2007).
9. Sagara, I. et al. Efficacy and safety of a fixed dose artesunate-sulphamethoxypyrazinepyrimethamine compared to artemether- lumefantrine for the treatment of uncomplicated falciparum malaria across Africa: a randomized multi-centre trial. Malar. J. 8, 63 (2009).
10. Piola, P. et al. Efficacy and safety of artemether-lumefantrine compared with quinine in pregnant women with uncomplicated Plasmodium falciparum malaria: an open-label, randomised, non-inferiority trial. Lancet Infect. Dis. 10, 762-769 (2010).
11. Abdulla, S. et al. Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial. Lancet 372, 1819-1827 (2008).
12. Hatz, C. et al. Treatment of acute uncomplicated falciparum malaria with artemetherlumefantrine in nonimmune populations: a safety, efficacy, and pharmacokinetic study. Am. J. Trop. Med. Hyg. 78, 241-247 (2008). (Pubitemid 351844558)
13. McGready, R. et al. A randomised controlled trial of artemether- lumefantrine versus artesunate for uncomplicated plasmodium falciparum treatment in pregnancy. PLoS Med. 5, e253 (2008).
14. Cheeseman, I.H. et al. A major genome region underlying artemisinin resistance in malaria. Science 336, 79-82 (2012).
15. McGready, R. et al. The pharmacokinetics of artemether and lumefantrine in pregnant women with uncomplicated falciparum malaria. Eur. J. Clin. Pharmacol. 62, 1021-1031 (2006). (Pubitemid 44786494)
16. McGready, R. et al. Pharmacokinetics of dihydroartemisinin following oral artesunate treatment of pregnant women with acute uncomplicated falciparum malaria. Eur. J. Clin. Pharmacol. 62, 367-371 (2006).
17. Tarning, J. et al. Population pharmacokinetic and pharmacodynamic modeling of amodiaquine and desethylamodiaquine in women with Plasmodium vivax malaria during and after pregnancy. Antimicrob. Agents Chemother. 56, 5764-5773 (2012).
18. Rijken MJ, McGready R, Jullien V, Tarning J, Lindegardh N, Phyo AP, et al. Pharmacokinetics of amodiaquine and desethylamodiaquine in pregnant and post-partum women with Plasmodium vivax malaria. Antimicrob. Agents Chemother. E-pub ahead of print 29 June 2011. (2011).
19. Tarning, J. et al. Population pharmacokinetics of dihydroartemisinin and piperaquine in pregnant and non-pregnant women with uncomplicated malaria. Antimicrob. Agents Chemother. 56, 1997-2007 (2012).
20. Rijken, M.J. et al. Pharmacokinetics of dihydroartemisinin and piperaquine in pregnant and nonpregnant women with uncomplicated falciparum malaria. Antimicrob. Agents Chemother. 55, 5500-5506 (2011).
21. Tarning, J. et al. Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria. Antimicrob. Agents Chemother. 53, 3837-3846 (2009).
22. McGready, R. et al. The pharmacokinetics of atovaquone and proguanil in pregnant women with acute falciparum malaria. Eur. J. Clin. Pharmacol. 59, 545-552 (2003). (Pubitemid 37368905)
23. Nyunt, M.M. et al. Pharmacokinetics of sulfadoxine and pyrimethamine in intermittent preventive treatment of malaria in pregnancy. Clin. Pharmacol. Ther. 87, 226-234 (2010).
24. Green, M.D. et al. Pharmacokinetics of sulfadoxine-pyrimethamine in HIV-infected and uninfected pregnant women in Western Kenya. J. Infect. Dis. 196, 1403-1408 (2007). (Pubitemid 351412014)
25. Karunajeewa, H.A. et al. Pharmacokinetic properties of sulfadoxine-pyrimethamine in pregnant women. Antimicrob. Agents Chemother. 53, 4368-4376 (2009).
26. Salman, S. et al. Population pharmacokinetics of artemether, lumefantrine, and their respective metabolites in Papua New Guinean children with uncomplicated malaria. Antimicrob. Agents Chemother. 55, 5306-5313 (2011).
27. van Vugt, M., Ezzet, F., Phaipun, L., Nosten, F. & White, N.J. The relationship between capillary and venous concentrations of the antimalarial drug lumefantrine (benflumetol). Trans. R. Soc. Trop. Med. Hyg. 92, 564-565 (1998). (Pubitemid 28486492)
28. Wahajuddin, Singh, S.P., Raju, K.S., Nafis, A., Puri, S.K., Jain, G.K. Intravenous pharmacokinetics, oral bioavailability, dose proportionality and in situ permeability of antimalarial lumefantrine in rats. Malar. J. 10, 293 (2011).
29. Dawes, M. & Chowienczyk, P.J. Drugs in pregnancy. Pharmacokinetics in pregnancy. Best Pract. Res. Clin. Obstet. Gynaecol. 15, 819-826 (2001).
30. Tyner, S.D. et al. Ex vivo drug sensitivity profiles of Plasmodium falciparum field isolates from Cambodia and Thailand, 2005 to 2010, determined by a histidine-rich protein-2 assay. Malar. J. 11, 198 (2012).
31. Wong, R.P., Salman, S., Ilett, K.F., Siba, P.M., Mueller, I. & Davis, T.M. Desbutyllumefantrine is a metabolite of lumefantrine with potent in vitro antimalarial activity that may influence artemether-lumefantrine treatment outcome. Antimicrob. Agents Chemother. 55, 1194-1198 (2011).
32. Noedl, H., Allmendinger, T., Prajakwong, S., Wernsdorfer, G. & Wernsdorfer, W.H. Desbutylbenflumetol, a novel antimalarial compound: in vitro activity in fresh isolates of Plasmodium falciparum from Thailand. Antimicrob. Agents Chemother. 45, 2106-2109 (2001). (Pubitemid 32591705)
33. Tarning, J. et al. Population pharmacokinetic and pharmacodynamic modeling of amodiaquine and desethylamodiaquine in women with Plasmodium vivax malaria during and after pregnancy. Antimicrob. Agents Chemother. 56, 5764-5773 (2012).
34. Ashley, E.A. et al. How much fat is necessary to optimize lumefantrine oral bioavailability? Trop. Med. Int. Health 12, 195-200 (2007).
35. Annerberg, A., Singtoroj, T., Tipmanee, P., White, N.J., Day, N.P. & Lindegårdh, N. High throughput assay for the determination of lumefantrine in plasma. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 822, 330-333 (2005). (Pubitemid 40994071)
36. Beal, S.L., Boeckman, A.J., Sheiner, L.B. NONMEM User's Guides. (NONMEM Project Group, University of California, San Francisco, CA, 1992).
37. Lindbom, L., Pihlgren, P., Jonsson, E.N. & Jonsson, N. PsN-Toolkit-a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. Comput. Methods Programs Biomed. 79, 241-257 (2005). (Pubitemid 41196689)
38. Lindbom, L., Ribbing, J. & Jonsson, E.N. Perl-speaks-NONMEM (PsN)-a Perl module for NONMEM related programming. Comput. Methods Programs Biomed. 75, 85-94 (2004). (Pubitemid 38798039)
39. Jonsson, E.N. & Karlsson, M.O. Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput. Methods Programs Biomed. 58, 51-64 (1999). (Pubitemid 29049052)
40. Jonsson, E.N. & Karlsson, M.O. Automated covariate model building within NONMEM. Pharm. Res. 15, 1463-1468 (1998). (Pubitemid 28427937)
41. Ravva, P., Gastonguay, M.R., Tensfeldt, T.G. & Faessel, H.M. Population pharmacokinetic analysis of varenicline in adult smokers. Br. J. Clin. Pharmacol. 68, 669-681 (2009).
42. Savic, R.M. & Karlsson, M.O. Importance of shrinkage in empirical bayes estimates for diagnostics: problems and solutions. AAPS J. 11, 558-669 (2009).
43. Bergstrand, M., Hooker, A.C., Wallin, J.E. & Karlsson, M.O. Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J. 13, 143-151 (2011).