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Population Pharmacokinetic Properties of Piperaquine in Falciparum Malaria: An Individual Participant Data Meta-Analysis


Joel Tarning and colleagues combine individual participant data from clinical trials to develop a pharmacokinetic model and derive an optimized dose regimen for malaria treatment in children.


Vyšlo v časopise: Population Pharmacokinetic Properties of Piperaquine in Falciparum Malaria: An Individual Participant Data Meta-Analysis. PLoS Med 14(1): e32767. doi:10.1371/journal.pmed.1002212
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1002212

Souhrn

Joel Tarning and colleagues combine individual participant data from clinical trials to develop a pharmacokinetic model and derive an optimized dose regimen for malaria treatment in children.


Zdroje

1. World Health Organization. World malaria report 2015. Geneva: World Health Organization; 2015.

2. World Health Organization. Guidelines for the treatment of malaria. 3rd edition. Geneva: World Health Organization; 2015.

3. White NJ. Assessment of the pharmacodynamic properties of antimalarial drugs in vivo. Antimicrob Agents Chemother. 1997;41(7):1413–22. 9210658

4. Ashley EA, McGready R, Hutagalung R, Phaiphun L, Slight T, Proux S, et al. A randomized, controlled study of a simple, once-daily regimen of dihydroartemisinin-piperaquine for the treatment of uncomplicated, multidrug-resistant falciparum malaria. Clin Infect Dis. 2005;41(4):425–32. doi: 10.1086/432011 16028147

5. Ashley EA, Krudsood S, Phaiphun L, Srivilairit S, McGready R, Leowattana W, et al. Randomized, controlled dose-optimization studies of dihydroartemisinin-piperaquine for the treatment of uncomplicated multidrug-resistant falciparum malaria in Thailand. J Infect Dis. 2004;190(10):1773–82. doi: 10.1086/425015 15499533

6. Denis MB, Davis TM, Hewitt S, Incardona S, Nimol K, Fandeur T, et al. Efficacy and safety of dihydroartemisinin-piperaquine (Artekin) in Cambodian children and adults with uncomplicated falciparum malaria. Clin Infect Dis. 2002;35(12):1469–76. doi: 10.1086/344647 12471565

7. Karunajeewa H, Lim C, Hung TY, Ilett KF, Denis MB, Socheat D, et al. Safety evaluation of fixed combination piperaquine plus dihydroartemisinin (Artekin) in Cambodian children and adults with malaria. Br J Clin Pharmacol. 2004;57(1):93–9. doi: 10.1046/j.1365-2125.2003.01962.x 14678346

8. Tran TH, Dolecek C, Pham PM, Nguyen TD, Nguyen TT, Le HT, et al. Dihydroartemisinin-piperaquine against multidrug-resistant Plasmodium falciparum malaria in Vietnam: randomised clinical trial. Lancet. 2004;363(9402):18–22. 14723988

9. White NJ. How antimalarial drug resistance affects post-treatment prophylaxis. Malar J. 2008;7:9. doi: 10.1186/1475-2875-7-9 18186948

10. Bergstrand M, Nosten F, Lwin KM, Karlsson MO, White NJ, Tarning J. Characterization of an in vivo concentration-effect relationship for piperaquine in malaria chemoprevention. Sci Transl Med. 2014;6(260):260ra147. doi: 10.1126/scitranslmed.3005311 25355697

11. Lwin KM, Phyo AP, Tarning J, Hanpithakpong W, Ashley EA, Lee SJ, et al. Randomized, double-blind, placebo-controlled trial of monthly versus bimonthly dihydroartemisinin-piperaquine chemoprevention in adults at high risk of malaria. Antimicrob Agents Chemother. 2012;56(3):1571–7. doi: 10.1128/AAC.05877-11 22252804

12. White NJ, Stepniewska K, Barnes K, Price RN, Simpson J. Simplified antimalarial therapeutic monitoring: using the day-7 drug level? Trends Parasitol. 2008;24(4):159–63. doi: 10.1016/j.pt.2008.01.006 18353727

13. Sigma-Tau. Application for inclusion of dihydroartemisinin plus piperaquine (DHA/PPQ) fixed dose combination tablets in the 17th WHO Model List of Essential Medicines. 2010 Nov 15 [cited 2016 Dec 1]. http://www.who.int/selection_medicines/committees/expert/18/applications/D_Piperaquine.pdf.

14. Beijing Holley-Cotec Pharmaceuticals. DUO-COTECXIN/6T. 2015 [cited 2015 Dec 15]. http://en.holleycotec.com/products_detail/&productId=29.html.

15. Beijing Holley-Cotec Pharmaceuticals. DUO-CORTECXIN/9T. 2015 [cited 2015 Dec 15]. http://en.holleycotec.com/products_detail/&productId=28.html.

16. Dondorp AM, Nosten F, Yi P, Das D, Phyo AP, Tarning J, et al. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med. 2009;361(5):455–67. doi: 10.1056/NEJMoa0808859 19641202

17. Ashley EA, Dhorda M, Fairhurst RM, Amaratunga C, Lim P, Suon S, et al. Spread of artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med. 2014;371(5):411–23. doi: 10.1056/NEJMoa1314981 25075834

18. Amaratunga C, Lim P, Suon S, Sreng S, Mao S, Sopha C, et al. Dihydroartemisinin–piperaquine resistance in Plasmodium falciparum malaria in Cambodia: a multisite prospective cohort study. Lancet Infect Dis. 2016;16(3):357–65. doi: 10.1016/S1473-3099(15)00487-9 26774243

19. WorldWide Antimalarial Resistance Network (WWARN) DP Study Group. The effect of dosing regimens on the antimalarial efficacy of dihydroartemisinin-piperaquine: a pooled analysis of individual patient data. PLoS Med. 2013;10(12):e1001564. doi: 10.1371/journal.pmed.1001564 24311989

20. Carneiro I, Roca-Feltrer A, Griffin JT, Smith L, Tanner M, Schellenberg JA, et al. Age-patterns of malaria vary with severity, transmission intensity and seasonality in sub-Saharan Africa: a systematic review and pooled analysis. PLoS ONE. 2010;5(2):e8988. doi: 10.1371/journal.pone.0008988 20126547

21. Zwang J, Ashley EA, Karema C, D’Alessandro U, Smithuis F, Dorsey G, et al. Safety and efficacy of dihydroartemisinin-piperaquine in falciparum malaria: a prospective multi-centre individual patient data analysis. PLoS ONE. 2009;4(7):e6358. doi: 10.1371/journal.pone.0006358 19649267

22. Tarning J, Ashley EA, Lindegardh N, Stepniewska K, Phaiphun L, Day NP, et al. Population pharmacokinetics of piperaquine after two different treatment regimens with dihydroartemisinin-piperaquine in patients with Plasmodium falciparum malaria in Thailand. Antimicrob Agents Chemother. 2008;52(3):1052–61. doi: 10.1128/AAC.00955-07 18180343

23. Hung TY, Davis TM, Ilett KF, Karunajeewa H, Hewitt S, Denis MB, et al. Population pharmacokinetics of piperaquine in adults and children with uncomplicated falciparum or vivax malaria. Br J Clin Pharmacol. 2004;57(3):253–62. doi: 10.1046/j.1365-2125.2003.02004.x 14998421

24. Tarning J, Zongo I, Somé FA, Rouamba N, Parikh S, Rosenthal PJ, et al. Population pharmacokinetics and pharmacodynamics of piperaquine in children with uncomplicated falciparum malaria. Clin Pharmacol Ther. 2012;91(3):497–505. doi: 10.1038/clpt.2011.254 22258469

25. Tarning J, Lindegardh N, Lwin KM, Annerberg A, Kiricharoen L, Ashley E, et al. Population pharmacokinetic assessment of the effect of food on piperaquine bioavailability in patients with uncomplicated malaria. Antimicrob Agents Chemother. 2014;58(4):2052–8. doi: 10.1128/AAC.02318-13 24449770

26. Sim IK, Davis TM, Ilett KF. Effects of a high-fat meal on the relative oral bioavailability of piperaquine. Antimicrob Agents Chemother. 2005;49(6):2407–11. doi: 10.1128/AAC.49.6.2407-2411.2005 15917540

27. Tarning J, Rijken MJ, McGready R, Phyo AP, Hanpithakpong W, Day NPJ, et al. Population pharmacokinetics of dihydroartemisinin and piperaquine in pregnant and nonpregnant women with uncomplicated malaria. Antimicrob Agents Chemother. 2012;56(4):1997–2007. doi: 10.1128/AAC.05756-11 22252822

28. Zaloumis S, Humberstone A, Charman SA, Price RN, Moehrle J, Gamo-Benito J, et al. Assessing the utility of an anti-malarial pharmacokinetic-pharmacodynamic model for aiding drug clinical development. Malar J. 2012;11(1):303.

29. Hoglund RM, Adam I, Hanpithakpong W, Ashton M, Lindegardh N, Day NPJ, et al. A population pharmacokinetic model of piperaquine in pregnant and non-pregnant women with uncomplicated Plasmodium falciparum malaria in Sudan. Malar J. 2012;11:398. doi: 10.1186/1475-2875-11-398 23190801

30. Sambol NC, Yan L, Creek DJ, McCormack SA, Arinaitwe E, Bigira V, et al. Population pharmacokinetics of piperaquine in young Ugandan children treated with dihydroartemisinin-piperaquine for uncomplicated malaria. Clin Pharmacol Ther. 2015;98(1):87–95. doi: 10.1002/cpt.104 25732044

31. Hai TN, Hietala SF, Van Huong N, Ashton M. The influence of food on the pharmacokinetics of piperaquine in healthy Vietnamese volunteers. Acta Trop. 2008;107(2):145–9. doi: 10.1016/j.actatropica.2008.05.013 18585670

32. Annerberg A, Lwin KM, Lindegardh N, Khrutsawadchai S, Ashley E, Day NPJ, et al. A small amount of fat does not affect piperaquine exposure in patients with malaria. Antimicrob Agents Chemother. 2011;55(9):3971–6. doi: 10.1128/AAC.00279-11 21709087

33. Karunajeewa HA, Ilett KF, Mueller I, Siba P, Law I, Page-Sharp M, et al. Pharmacokinetics and efficacy of piperaquine and chloroquine in Melanesian children with uncomplicated malaria. Antimicrob Agents Chemother. 2008;52(1):237–43. doi: 10.1128/AAC.00555-07 17967917

34. Riley RD, Lambert PC, Abo-Zaid G. Meta-analysis of individual participant data: rationale, conduct, and reporting. BMJ. 2010;340:c221. doi: 10.1136/bmj.c221 20139215

35. Price RN, Hasugian AR, Ratcliff A, Siswantoro H, Purba HL, Kenangalem E, et al. Clinical and pharmacological determinants of the therapeutic response to dihydroartemisinin-piperaquine for drug-resistant malaria. Antimicrob Agents Chemother. 2007;51(11):4090–7. doi: 10.1128/AAC.00486-07 17846129

36. WorldWide Antimalarial Resistance Network. The WWARN project terms of submission. 2013 Jun [cited 2015 Sep 19]. http://www.wwarn.org/sites/default/files/attachments/documents/TermsOfSubmission.pdf.

37. WorldWide Antimalarial Resistance Network. Data management and statistical analysis plan (DMSAP) version 1.0. Pharmacology module. 2011 Jun 23 [cited 2016 Dec 1]. http://www.wwarn.org/sites/default/files/PharmacologyDMSAP.pdf.

38. WorldWide Antimalarial Resistance Network. Clinical module: data management and statistical analysis plan version 1.2. 2012 May 25 [cited 2016 Dec 1]. http://www.wwarn.org/sites/default/files/ClinicalDMSAP.pdf.

39. Borrmann S, Sasi P, Mwai L, Bashraheil M, Abdallah A, Muriithi S, et al. Declining responsiveness of Plasmodium falciparum infections to artemisinin-based combination treatments on the Kenyan coast. PLoS ONE. 2011;6(11):e26005. doi: 10.1371/journal.pone.0026005 22102856

40. Nguyen TC, Nguyen NQ, Nguyen XT, Bui D, Travers T, Edstein MD. Pharmacokinetics of the antimalarial drug piperaquine in healthy Vietnamese subjects. Am J Trop Med Hyg. 2008;79(4):620–3. 18840754

41. Chinh NT, Quang NN, Thanh NX, Dai B, Geue JP, Addison RS, et al. Pharmacokinetics and bioequivalence evaluation of two fixed-dose tablet formulations of dihydroartemisinin and piperaquine in Vietnamese subjects. Antimicrob Agents Chemother. 2009;53(2):828–31. doi: 10.1128/AAC.00927-08 19047656

42. Nguyen DVH, Nguyen QP, Nguyen ND, Le TTT, Nguyen TD, Dinh DN, et al. Pharmacokinetics and ex vivo pharmacodynamic antimalarial activity of dihydroartemisinin-piperaquine in patients with uncomplicated falciparum malaria in Vietnam. Antimicrob Agents Chemother. 2009;53(8):3534–7. doi: 10.1128/AAC.01717-08 19528277

43. Thanh NX, Trung TN, Phong NC, Quang HH, Dai B, Shanks GD, et al. The efficacy and tolerability of artemisinin-piperaquine (Artequick®) versus artesunate-amodiaquine (CoarsucamTM) for the treatment of uncomplicated Plasmodium falciparum malaria in south-central Vietnam. Malar J. 2012;11:217. doi: 10.1186/1475-2875-11-217 22741618

44. Adam I, Tarning J, Lindegardh N, Mahgoub H, McGready R, Nosten F. Pharmacokinetics of piperaquine in pregnant women in Sudan with uncomplicated Plasmodium falciparum malaria. Am J Trop Med Hyg. 2012;87(1):35–40. doi: 10.4269/ajtmh.2012.11-0410 22764289

45. Beal SL, Sheiner LB, Boeckmann AJ. NONMEM users guides. San Francisco: NONMEM Project Group, University of California San Francisco; 1992.

46. Beal SL, Sheiner LB. Estimating population kinetics. Crit Rev Biomed Eng. 1982;8(3):195–222. 6754254

47. Lindbom L, Ribbing J, Jonsson EN. Perl-speaks-NONMEM (PsN)—a Perl module for NONMEM related programming. Comput Methods Programs Biomed. 2004;75(2):85–94. doi: 10.1016/j.cmpb.2003.11.003 15212851

48. Jonsson EN, Karlsson MO. Xpose—an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput Methods Programs Biomed. 1999;58(1):51–64. 10195646

49. Keizer RJ, van Benten M, Beijnen JH, Schellens JHM, Huitema ADR. Piraña and PCluster: a modeling environment and cluster infrastructure for NONMEM. Comput Methods Programs Biomed. 2011;101(1):72–9. doi: 10.1016/j.cmpb.2010.04.018 20627442

50. Ashley EA, Stepniewska K, Lindegardh N, Annerberg A, Tarning J, McGready R, et al. Comparison of plasma, venous and capillary blood levels of piperaquine in patients with uncomplicated falciparum malaria. Eur J Clin Pharmacol. 2010;66(7):705–12. doi: 10.1007/s00228-010-0804-7 20300743

51. Bergstrand M, Hooker AC, Wallin JE, Karlsson MO. Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J. 2011;13(2):143–51. doi: 10.1208/s12248-011-9255-z 21302010

52. Savic RM, Karlsson MO. Importance of shrinkage in empirical Bayes estimates for diagnostics: problems and solutions. AAPS J. 2009;11(3):558–69. doi: 10.1208/s12248-009-9133-0 19649712

53. Saunders DL, Vanachayangkul P, Lon C. Dihydroartemisinin-piperaquine failure in Cambodia. N Engl J Med. 2014;371(5):484–5. doi: 10.1056/NEJMc1403007 25075853

54. Leang R, Taylor WRJ, Bouth DM, Song L, Tarning J, Char MC, et al. Evidence of Plasmodium falciparum malaria multidrug resistance to artemisinin and piperaquine in western Cambodia: dihydroartemisinin-piperaquine open-label multicenter clinical assessment. Antimicrob Agents Chemother. 2015;59(8):4719–26. doi: 10.1128/AAC.00835-15 26014949

55. Spring MD, Lin JT, Manning JE, Vanachayangkul P, Somethy S, Bun R, et al. Dihydroartemisinin-piperaquine failure associated with a triple mutant including kelch13 C580Y in Cambodia: an observational cohort study. Lancet Infect Dis. 2015;15(6):683–91. doi: 10.1016/S1473-3099(15)70049-6 25877962

56. Adjuik MA, Allan R, Anvikar AR, Ashley EA, Ba MS, Barennes H, et al. The effect of dosing strategies on the therapeutic efficacy of artesunate-amodiaquine for uncomplicated malaria: a meta-analysis of individual patient data. BMC Med. 2015;13:66. doi: 10.1186/s12916-015-0301-z 25888957

57. The effect of dose on the antimalarial efficacy of artemether-lumefantrine: a systematic review and pooled analysis of individual patient data. Lancet Infect Dis. 2015;15(6):692–702. doi: 10.1016/S1473-3099(15)70024-1 25788162

58. Tarning J, Thana P, Phyo AP, Lwin KM, Hanpithakpong W, Ashley EA, et al. Population pharmacokinetics and antimalarial pharmacodynamics of piperaquine in patients with Plasmodium vivax malaria in Thailand. CPT Pharmacometrics Syst Pharmacol. 2014;3:e132. doi: 10.1038/psp.2014.29 25163024

59. Salman S, Page-Sharp M, Batty KT, Kose K, Griffin S, Siba PM, et al. Pharmacokinetic comparison of two piperaquine-containing artemisinin combination therapies in Papua New Guinean children with uncomplicated malaria. Antimicrob Agents Chemother. 2012;56(6):3288–97. doi: 10.1128/AAC.06232-11 22470119

60. Roshammar D, Hai TN, Friberg Hietala S, Van Huong N, Ashton M. Pharmacokinetics of piperaquine after repeated oral administration of the antimalarial combination CV8 in 12 healthy male subjects. Eur J Clin Pharmacol. 2006;62(5):335–41. doi: 10.1007/s00228-005-0084-9 16570188

61. Anderson BJ, Holford NHG. Mechanistic basis of using body size and maturation to predict clearance in humans. Drug Metab Pharmacokinet. 2009;24(1):25–36. 19252334

62. Johnson TN, Tucker GT, Rostami-Hodjegan A. Development of CYP2D6 and CYP3A4 in the first year of life. Clin Pharmacol Ther. 2008;83(5):670–1. doi: 10.1038/sj.clpt.6100327 18043691

63. Anderson BJ, Holford NH. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol. 2008;48:303–32. doi: 10.1146/annurev.pharmtox.48.113006.094708 17914927

64. Manning J, Vanachayangkul P, Lon C, Spring M, So M, Sea D, et al. Randomized, double-blind, placebo-controlled clinical trial of a two-day regimen of dihydroartemisinin-piperaquine for malaria prevention halted for concern over prolonged corrected QT interval. Antimicrob Agents Chemother. 2014;58(10):6056–67. doi: 10.1128/AAC.02667-14 25092702

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