Population pharmacokinetics of mefloquine, piperaquine and artemether-lumefantrine in Cambodian and Tanzanian malaria patients

Malaria Journal

Volumn 12, Issue 1, 2013, Pages

  Staehli Hodel, Eva Maria ^a   Guidi, Monia ^b,c   Zanolari, Boris ^c   Mercier, Thomas ^c   Duong, Socheat ^d   Kabanywanyi, Abdunoor M ^e   Ariey, Frédéric ^f   Buclin, Thierry ^c   Beck, Hans Peter ^a   Decosterd, Laurent A ^c   Olliaro, Piero ^g   Genton, Blaise ^a,c   Csajka, Chantal ^b,c  

^a UNIVERSITY OF BASEL   (Switzerland)

^b UNIVERSITY OF GENEVA   (Switzerland)

^c LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^d National Center for Parasitology Entomology and Malaria Control   (Cambodia)

^e IFAKARA HEALTH INSTITUTE   (Tanzania)

^f INSTITUT PASTEUR DU CAMBODGE   (Cambodia)

^g WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

Artemether; Artemisinin based combination therapy; Cambodia; Lumefantrine; Malaria; Mefloquine; Nonlinear mixed effects modelling; Piperaquine; Population pharmacokinetics; Tanzania

Indexed keywords

ARTEMETHER; ARTEMETHER PLUS BENFLUMETOL; ARTESUNATE; BENFLUMETOL; CAFFEINE; CHLOROQUINE; CLARITHROMYCIN; DESBUTYL LUMEFANTRINE; DIHYDROARTEMISININ; DOXYCYCLINE; ERYTHROMYCIN; IBUPROFEN; MEFLOQUINE; METRONIDAZOLE; PIPERAQUINE; PYRIMETHAMINE; QUININE; TETRACYCLINE; UNCLASSIFIED DRUG;

ADOLESCENT; ADULT; AGED; ARTICLE; BODY WEIGHT; CAMBODIA; CHILD; COMPARTMENT MODEL; DRUG ABSORPTION; DRUG CLEARANCE; FEMALE; GASTROINTESTINAL TRACT; HUMAN; KINETICS; MAJOR CLINICAL STUDY; MALARIA; MALE; PRESCHOOL CHILD; SCHOOL CHILD; SIMULATION; TANZANIA;

ADOLESCENT; ADULT; AGED; ANTIMALARIALS; ARTEMISININS; CAMBODIA; CHILD; CHILD, PRESCHOOL; DRUG COMBINATIONS; ETHANOLAMINES; FEMALE; FLUORENES; HUMANS; INFANT; MALARIA; MALE; MEFLOQUINE; MIDDLE AGED; PLASMA; QUINOLINES; TANZANIA; YOUNG ADULT;

EID: 84880783058     PISSN: None     EISSN: 14752875     Source Type: Journal    
DOI: 10.1186/1475-2875-12-235     Document Type: Article

References (63)

1. WHO, Guidelines for the treatment of malaria Geneva: World Health Organization Second 2010
2. WHO, World Malaria Report 2011 Geneva: World Health Organization 2011
3. Sulfadoxine-pyrimethamine in treatment of malaria in Western Kenya: increasing resistance and underdosing. Terlouw DJ, Nahlen BL, Courval JM, Kariuki SK, Rosenberg OS, Oloo AJ, Kolczak MS, Hawley WA, Lal AA, Kuile FO, Antimicrob Agents Chemother 2003 47 2929 2932 10.1128/AAC.47.9.2929-2932.2003 12936996 (Pubitemid 37040270)
4. Antimalarial dosing regimens and drug resistance. Barnes KI, Watkins WM, White NJ, Trends Parasitol 2008 24 127 134 10.1016/j.pt.2007.11.008 18262470
5. Sulfadoxine-pyrimethamine pharmacokinetics in malaria: Pediatric dosing implications. Barnes KI, Little F, Smith PJ, Evans A, Watkins WM, White NJ, Clin Pharmacol Ther 2006 80 582 596 10.1016/j.clpt.2006.08.016 17178260 (Pubitemid 44920218)
6. WHO, Methods and techniques for assessing exposure to antimalarial drugs in clinical field studies Geneva: World Health Organization 2011
7. Defining adequate lumefantrine exposure in patients with uncomplicated malaria treated with artemether-lumefantrine. Stepniewska K, Workman L, Aweeka F, Borrmann S, Faucher J-F, Genton B, Lindegardh N, Martensson A, Mayxay M, Nosten F, Piola P, Ringwald P, White NJ, Barnes K, Poster LB-2212, presented at the 60th American Society of Tropical Medicine and Hygiene (ASTMH) Annual Meeting 3-8 December 2011, Philadelphia, PA, USA 2011
8. Population pharmacokinetics of mefloquine in patients with acute falciparum malaria. Simpson JA, Price R, ter Kuile F, Teja-Isavatharm P, Nosten F, Chongsuphajaisiddhi T, Looareesuwan S, Aarons L, White NJ, Clin Pharmacol Ther 1999 66 472 484 10.1016/S0009-9236(99)70010-X 10579474
9. World antimalarial resistance network (WARN) IV: Clinical pharmacology. Barnes KI, Lindegardh N, Ogundahunsi O, Olliaro P, Plowe CV, Randrianarivelojosia M, Gbotosho GO, Watkins WM, Sibley CH, White NJ, Malar J 2007 6 122 10.1186/1475-2875-6-122 17822537 (Pubitemid 47561491)
10. Current knowledge and challenges of antimalarial drugs for treatment and prevention in pregnancy. Sevene E, Gonzalez R, Menendez C, Expert Opin Pharmacother 2010 11 1277 1293 10.1517/14656561003733599 20408744
11. Simplified antimalarial therapeutic monitoring: using the day-7 drug level? White NJ, Stepniewska K, Barnes K, Price RN, Simpson J, Trends Parasitol 2008 24 159 163 10.1016/j.pt.2008.01.006 18353727
12. Treatment of Plasmodium falciparum malaria with pyrimethamine- sulfadoxine: selective pressure for resistance is a function of long elimination half-life. Watkins WM, Mosobo M, Trans R Soc Trop Med Hyg 1993 87 75 78 10.1016/0035-9203(93)90431-O 8465404
13. Efficacy of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in northwest Cambodia. Denis MB, Tsuyuoka R, Lim P, Lindegardh N, Yi P, Top SN, Socheat D, Fandeur T, Annerberg A, Christophel EM, Ringwald P, Trop Med Int Health 2006 11 1800 1807 10.1111/j.1365-3156.2006. 01739.x 17176344 (Pubitemid 44813874)
14. Efficacy and safety of artemisinin-based antimalarial in the treatment of uncomplicated malaria in children in southern Tanzania. Kabanywanyi AM, Mwita A, Sumari D, Mandike R, Mugittu K, Abdulla S, Malar J 2007 6 146 10.1186/1475-2875-6-146 17996121
15. Antimalarial drug resistance, Thai-Cambodian border. Wkly Epidemiol Rec 2009 84 94 95 19280732
16. Resistance to artemisinin derivatives along the Thai-Cambodian border. Wkly Epidemiol Rec 2007 82 360 17933087
17. Artemisinin resistance in Plasmodium falciparum malaria. Dondorp AM, Nosten F, Yi P, Das D, Phyo AP, Tarning J, Lwin KM, Ariey F, Hanpithakpong W, Lee SJ, Ringwald P, Silamut K, Imwong M, Chotivanich K, Lim P, Herdman T, An SS, Yeung S, Singhasivanon P, Day NP, Lindegardh N, Socheat D, White NJ, N Engl J Med 2009 361 455 467 10.1056/NEJMoa0808859 19641202
18. Artemisinin resistance could endanger fight against malaria. Burki T, Lancet Infect Dis 2009 9 213
19. Malaria. Signs of drug resistance rattle experts, trigger bold plan. Enserink M, Science 2008 322 1776 10.1126/science.322.5909.1776 19095911
20. Are we losing artemisinin combination therapy already? Duffy PE, Sibley H, Lancet 2005 366 1908 1909 10.1016/S0140-6736(05)67768-9 16325683 (Pubitemid 41713975)
21. The last man standing is the most resistant: eliminating artemisinin-resistant malaria in Cambodia. Maude RJ, Pontavornpinyo W, Saralamba S, Aguas R, Yeung S, Dondorp AM, Day NPJ, White NJ, White LJ, Malar J 2009 8 31 10.1186/1475-2875-8-31 19228438
22. Evidence of artemisinin-resistant malaria in Western Cambodia. Noedl H, Se Y, Schaecher K, Smith BL, Socheat D, Fukuda MM, Artemisinin Resistance in Cambodia 1 (ARC1) Study Consortium, N Engl J Med 2008 359 2619 2620 10.1056/NEJMc0805011 19064625
23. Countries race to contain resistance to key antimalarial. Samarasekera U, Lancet 2009 374 277 280 10.1016/S0140-6736(09)61349-0 19639670
24. WHO, Drug resistance could set back malaria control success World Health Organization 2009 http://www.who.int/mediacentre/news/releases/2009/malaria- drug-resistance-20090225/en/
25. A single LC-tandem mass spectrometry method for the simultaneous determination of 14 antimalarial drugs and their metabolites in human plasma. Hodel EM, Zanolari B, Mercier T, Biollaz J, Keiser J, Olliaro P, Genton B, Decosterd LA, J Chromatogr B Analyt Technol Biomed Life Sci 2009 877 867 886 10.1016/j.jchromb.2009.02.006 19249251
26. A microarray-based system for the simultaneous analysis of single nucleotide polymorphisms in human genes involved in the metabolism of anti-malarial drugs. Hodel EM, Ley SD, Qi W, Ariey F, Genton B, Beck HP, Malar J 2009 8 285 10.1186/1475-2875-8-285 20003204
27. Effect of Single Nucleotide Polymorphisms in Cytochrome P450 Isoenzyme and N-Acetyltransferase 2 Genes on the Metabolism of Artemisinin-Based Combination Therapies in Malaria Patients from Cambodia and Tanzania. Staehli Hodel EM, Csajka C, Ariey F, Guidi M, Kabanywanyi AM, Duong S, Decosterd LA, Olliaro P, Beck HP, Genton B, Antimicrob Agents Chemother 2013 57 950 958 10.1128/AAC.01700-12 23229480
28. NONMEM Users Guides (1989-2006) Ellicott City, Maryland, USA: Icon Development Solutions, Beal SL, Sheiner LB, Boeckmann AJ, 2006
29. Residual antimalarial concentrations before treatment in patients with malaria from Cambodia: indication of drug pressure. Hodel EM, Genton B, Zanolari B, Mercier T, Duong S, Beck HP, Olliaro P, Decosterd LA, Ariey F, J Infect Dis 2010 202 1088 1094 10.1086/655779 20726764
30. Residual antimalarials in malaria patients from Tanzania-implications on drug efficacy assessment and spread of parasite resistance. Hodel EM, Kabanywanyi AM, Malila A, Zanolari B, Mercier T, Beck HP, Buclin T, Olliaro P, Decosterd LA, Genton B, PLoS One 2009 4 8184 10.1371/journal.pone.0008184 20011529
31. Characterization of human urinary metabolites of the antimalarial piperaquine. Tarning J, Bergqvist Y, Day NP, Bergquist J, Arvidsson B, White NJ, Ashton M, Lindegardh N, Drug Metab Dispos 2006 34 2011 2019 10.1124/dmd.106.011494 16956956 (Pubitemid 44837762)
32. Clinical pharmacokinetics and pharmacodynamics of artemether- lumefantrine. White NJ, van Vugt M, Ezzet F, Clin Pharmacokinet 1999 37 105 125 10.2165/00003088-199937020-00002 10496300 (Pubitemid 29431479)
33. Pharmacokinetics of artemisinin-type compounds. Navaratnam V, Mansor SM, Sit NW, Grace J, Li QG, Olliaro P, Clin Pharmacokinet 2000 39 255 270 10.2165/00003088-200039040-00002 11069212
34. Coartem. Novartis Pharma Corporation, Full prescribing information 2009
35. The potential for interactions between antimalarial and antiretroviral drugs. Khoo S, Back D, Winstanley P, AIDS 2005 19 995 1005 10.1097/01.aids. 0000174445.40379.e0 15958830 (Pubitemid 40961139)
36. Glucuronidation of dihydroartemisinin in vivo and by human liver microsomes and expressed UDP-glucuronosyltransferases. Ilett KF, Ethell BT, Maggs JL, Davis TME, Batty KT, Burchell B, Binh TQ, Thu LTA, Hung NC, Pirmohamed M, Park BK, Edwards G, Drug Metab Dispos 2002 30 1005 1012 10.1124/dmd.30.9. 1005 12167566
37. Role of cytochrome P450 3A in the metabolism of mefloquine in human and animal hepatocytes. Fontaine F, de Sousa G, Burcham PC, Duchene P, Rahmani R, Life Sci 2000 66 2193 2212 10.1016/S0024-3205(00)00546-4 10834303 (Pubitemid 30313087)
38. Effect of rifampin on plasma concentrations of mefloquine in healthy volunteers. Ridtitid W, Wongnawa M, Mahatthanatrakul W, Chaipol P, Sunbhanich M, J Pharm Pharmacol 2000 52 1265 1269 10.1211/0022357001777243 11092571
39. Ketoconazole increases plasma concentrations of antimalarial mefloquine in healthy human volunteers. Ridtitid W, Wongnawa M, Mahatthanatrakul W, Raungsri N, Sunbhanich M, J Clin Pharm Ther 2005 30 285 290 10.1111/j.1365-2710. 2005.00651.x 15896247 (Pubitemid 41603053)
40. The contribution of the enzymes CYP2D6 and CYP2C19 in the demethylation of artemether in healthy subjects. van Agtmael MA, van der Graaf CAA, Dien TK, Koopmans RP, van Boxtel CJ, Eur J Drug Metab Pharmacokinet 1998 23 429 436 10.1007/BF03192305 9842988 (Pubitemid 28517733)
41. Mechanism-based concepts of size and maturity in pharmacokinetics. Anderson BJ, Holford NHG, Annu Rev Pharmacol Toxicol 2008 48 303 332 10.1146/annurev.pharmtox.48.113006.094708 17914927 (Pubitemid 351738156)
42. PsN-Toolkit - a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM. [Erratum appears in Comput Methods Programs Biomed. 2005 Dec;80(3):277 Note: Jonsson, Niclas [corrected to Jonsson, E Niclas]]. Lindbom L, Pihlgren P, Jonsson EN, Comput Methods Programs Biomed 2005 79 241 257 10.1016/j.cmpb.2005.04.005 16023764 (Pubitemid 41196689)
43. Perl-speaks-NONMEM (PsN)-a Perl module for NONMEM related programming. Lindbom L, Ribbing J, Jonsson EN, Comput Methods Programs Biomed 2004 75 85 94 10.1016/j.cmpb.2003.11.003 15212851 (Pubitemid 38798039)
44. Perl-speaks-NONMEM (PsN). http://psn.sourceforge.net/
45. GraphPad Software. http://www.graphpad.com
46. Population pharmacokinetics and pharmacodynamics of artemether and lumefantrine during combination treatment in children with uncomplicated falciparum malaria in Tanzania. Hietala SF, Martensson A, Ngasala B, Dahlstrom S, Lindegardh N, Premji Z, Farnert A, Gil P, Bjorkman A, Ashton M, Antimicrob Agents Chemother 2010 54 4780 4788 10.1128/AAC.00252-10 20713675
47. Population pharmacokinetics and therapeutic response of CGP56697 (artemether plus benflumetol) in malaria patients. Ezzet F, Mull R, Karbwang J, Br J Clin Pharmacol 1998 46 553 561 9862244 (Pubitemid 28522119)
48. Population pharmacokinetics of artemether, lumefantrine, and their respective metabolites in Papua New Guinean children with uncomplicated malaria. Salman S, Page-Sharp M, Griffin S, Kose K, Siba PM, Ilett KF, Mueller I, Davis TM, Antimicrob Agents Chemother 2011 55 5306 5313 10.1128/AAC.05136-11 21876056
49. Population pharmacokinetics of artemether and dihydroartemisinin in pregnant women with uncomplicated Plasmodium falciparum malaria in Uganda. Tarning J, Kloprogge F, Piola P, Dhorda M, Muwanga S, Turyakira E, Nuengchamnong N, Nosten F, Day NP, White NJ, Guerin PJ, Lindegardh N, Malar J 2012 11 293 10.1186/1475-2875-11-293 22913677
50. Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria. Tarning J, McGready R, Lindegardh N, Ashley EA, Pimanpanarak M, Kamanikom B, Annerberg A, Day NPJ, Stepniewska K, Singhasivanon P, White NJ, Nosten F, Antimicrob Agents Chemother 2009 53 3837 3846 10.1128/AAC.00195-09 19564366
51. Population pharmacokinetics of mefloquine in military personnel for prophylaxis against malaria infection during field deployment. Charles BG, Blomgren A, Nasveld PE, Kitchener SJ, Jensen A, Gregory RM, Robertson B, Harris IE, Reid MP, Edstein MD, Eur J Clin Pharmacol 2007 63 271 278 10.1007/s00228-006-0247-3 17216435 (Pubitemid 46233155)
52. Population pharmacokinetic assessment of a new regimen of mefloquine used in combination treatment of uncomplicated falciparum malaria. Ashley EA, Stepniewska K, Lindegardh N, McGready R, Hutagalung R, Hae R, Singhasivanon P, White NJ, Nosten F, Antimicrob Agents Chemother 2006 50 2281 2285 10.1128/AAC.00040-06 16801402 (Pubitemid 43993164)
53. Population pharmacokinetics of piperaquine after two different treatment regimens with dihydroartemisinin-piperaquine in patients with Plasmodium falciparum malaria in Thailand. Tarning J, Ashley EA, Lindegardh N, Stepniewska K, Phaiphun L, Day NPJ, McGready R, Ashton M, Nosten F, White NJ, Antimicrob Agents Chemother 2008 52 1052 1061 10.1128/AAC.00955-07 18180343 (Pubitemid 351358388)
54. Population pharmacokinetics and pharmacodynamics of piperaquine in children with uncomplicated falciparum malaria. Tarning J, Zongo I, Some FA, Rouamba N, Parikh S, Rosenthal PJ, Hanpithakpong W, Jongrak N, Day NP, White NJ, Nosten F, Ouedraogo JB, Lindegardh N, Clin Pharmacol Ther 2012 91 497 505 10.1038/clpt.2011.254 22258469
55. Population pharmacokinetics of dihydroartemisinin and piperaquine in pregnant and nonpregnant women with uncomplicated malaria. Tarning J, Rijken MJ, McGready R, Phyo AP, Hanpithakpong W, Day NP, White NJ, Nosten F, Lindegardh N, Antimicrob Agents Chemother 2012 56 1997 2007 10.1128/AAC.05756-11 22252822
56. Food increases the bioavailability of mefloquine. Crevoisier C, Handschin J, Barre J, Roumenov D, Kleinbloesem C, Eur J Clin Pharmacol 1997 53 135 139 10.1007/s002280050351 9403285 (Pubitemid 27491666)
57. Lariam. Hoffmann-La Roche Ltd, Full prescribing information 2009
58. Molecular and pharmacological determinants of the therapeutic response to artemether-lumefantrine in multidrug-resistant Plasmodium falciparum malaria. Price RN, Uhlemann AC, van Vugt M, Brockman A, Hutagalung R, Nair S, Nash D, Singhasivanon P, Anderson TJC, Krishna S, White NJ, Nosten F, Clin Infect Dis 2006 42 1570 1577 10.1086/503423 16652314
59. Effects of a high-fat meal on the relative oral bioavailability of piperaquine. Sim IK, Davis TME, Ilett KF, Antimicrob Agents Chemother 2005 49 2407 2411 10.1128/AAC.49.6.2407-2411.2005 15917540 (Pubitemid 40734473)
60. Adherence to and acceptability of artemether-lumefantrine as first-line anti-malarial treatment: evidence from a rural community in Tanzania. Kabanywanyi AM, Lengeler C, Kasim P, King'eng'ena S, Schlienger R, Mulure N, Genton B, Malar J 2010 9 48 10.1186/1475-2875-9-48 20149235
61. Pharmacokinetics of artemether and dihydroartemisinin in healthy Pakistani male volunteers treated with artemether-lumefantrine. Ali S, Najmi MH, Tarning J, Lindegardh N, Malar J 2010 9 275 10.1186/1475-2875-9-275 20932349
62. 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. Abdulla S, Sagara I, Borrmann S, D'Alessandro U, Gonzalez R, Hamel M, Ogutu B, Martensson A, Lyimo J, Maiga H, Sasi P, Nahum A, Bassat Q, Juma E, Otieno L, Björkman A, Beck HP, Andriano K, Cousin M, Lefèvre G, Ubben D, Premji Z, Lancet 2008 372 1819 1827 10.1016/S0140-6736(08)61492-0 18926569
63. Pharmacokinetics and pharmacodynamics of lumefantrine (benflumetol) in acute falciparum malaria. Ezzet F, van Vugt M, Nosten F, Looareesuwan S, White NJ, Antimicrob Agents Chemother 2000 44 697 704 10.1128/AAC.44.3.697-704.2000 10681341 (Pubitemid 30117964)