Population pharmacokinetic evaluation with external validation and bayesian estimator of voriconazole in liver transplant recipients

Clinical Pharmacokinetics

Volumn 50, Issue 3, 2011, Pages 201-214

  Han, Kelong ^a,b   Bies, Robert ^c,d   Johnson, Heather ^a   Capitano, Blair ^a,e   Venkataramanan, Raman ^a,f  

^a UNIVERSITY OF PITTSBURGH   (United States)

^b GENENTECH INC   (United States)

^c INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF TORONTO   (Canada)

^e Pfizer Global Pharmaceuticals   (United States)

^f UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

Author keywords

Antifungals; Dose prediction; Liver transplant; Pharmacokinetic modelling; pharmacokinetics; Population pharmacokinetics; Voriconazole

Indexed keywords

ALANINE AMINOTRANSFERASE; PANTOPRAZOLE; VORICONAZOLE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; BAYESIAN LEARNING; CLINICAL ARTICLE; DRUG ABSORPTION; DRUG ADMINISTRATION ROUTE; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG SCREENING; FEMALE; GRAFT RECIPIENT; HUMAN; INVASIVE ASPERGILLOSIS; LIVER TRANSPLANTATION; MALE; PHARMACOKINETICS; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; RACE; THERAPY EFFECT; VALIDATION STUDY;

ADULT; AGED; ANTIFUNGAL AGENTS; BAYES THEOREM; FEMALE; HUMANS; LIVER TRANSPLANTATION; MALE; MIDDLE AGED; NONLINEAR DYNAMICS; PYRIMIDINES; TRIAZOLES;

EID: 79751482504     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.2165/11538690-000000000-00000     Document Type: Article

References (42)

1. Panackal AA, Dahlman A, Keil KT, et al. Outbreak of invasive aspergil- losis among renal transplant recipients. Transplantation 2003; 75 (7): 1050-3. (Pubitemid 36438538)
2. Lin SJ, Schranz J, Teutsch SM. Aspergillosis case-fatality rate: systematic review of the literature. Clin Infect Dis 2001; 32 (3): 358-66. (Pubitemid 32173620)
3. George D, Miniter P, Andriole VT. Efficacy of UK-109496, a new azole antifungal agent, in an experimental model of invasive aspergillosis. Anti-microb Agents Chemother 1996; 40 (1): 86-91. (Pubitemid 26020748)
4. Patterson TF. Role of newer azoles in surgical patients. J Chemother 1999; 11 (6): 504-12. (Pubitemid 30029548)
5. Sheehan DJ, Hitchcock CA, Sibley CM. Current and emerging azole antifungal agents. Clin Microbiol Rev 1999; 12 (1): 40-79. (Pubitemid 29055953)
6. Sanati H, Belanger P, Fratti R, et al. A new triazole, voriconazole (UK-109,496), blocks sterol biosynthesis in Candida albicans and Candida krusei. Antimicrob Agents Chemother 1997; 41 (11): 2492-6. (Pubitemid 27467562)
7. Tintillier M, Kirch L, Goffin E, et al. Interaction between voriconazole and tacrolimus in a kidney-transplanted patient. Nephrol Dial Transplant 2005; 20 (3): 664-5. (Pubitemid 40378452)
8. Johnson LB, Kauffman CA. Voriconazole: a new triazole antifungal agent. Clin Infect Dis 2003; 36 (5): 630-7. (Pubitemid 36259570)
9. Pearson MM, Rogers PD, Cleary JD, et al. Voriconazole: a new triazole antifungal agent. Ann Pharmacother 2003; 37 (3): 420-32. (Pubitemid 36249646)
10. Scott LJ, Simpson D. Voriconazole: a review of its use in the management of invasive fungal infections. Drugs 2007; 67 (2): 269-98.
11. Lipp HP. Antifungal agents: clinical pharmacokinetics and drug interactions. Mycoses 2008; 51 Suppl. 1: 7-18.
12. Boyd AE, Modi S, Howard SJ, et al. Adverse reactions to voriconazole. Clin Infect Dis 2004; 39 (8): 1241-4. (Pubitemid 40169325)
13. Smith J, Safdar N, Knasinski V, et al. Voriconazole therapeutic drug mon- itoring. Antimicrob Agents Chemother 2006; 50 (4): 1570-2.
14. Trifilio S, Pennick G, Pi J, et al. Monitoring plasma voriconazole levels may be necessary to avoid subtherapeutic levels in hematopoietic stem cell transplant recipients. Cancer 2007; 109 (8): 1532-5. (Pubitemid 46595688)
15. Pascual A, Calandra T, Bolay S, et al. Voriconazole therapeutic drug mon- itoring in patients with invasive mycoses improves efficacy and safety outcomes. Clin Infect Dis 2008; 46 (2): 201-11. (Pubitemid 351269158)
16. Pascual A, Nieth V, Calandra T, et al. Variability of voriconazole plasma levels measured by new high-performance liquid chromatography and bioassay methods. Antimicrob Agents Chemother 2007; 51 (1): 137-43. (Pubitemid 46047698)
17. Purkins L, Wood N, Greenhalgh K, et al. Voriconazole, a novel wide-spectrum triazole: oral pharmacokinetics and safety. Br J Clin Pharmacol 2003; 56 Suppl. 1: 10-6. (Pubitemid 37491728)
18. Leveque D, Nivoix Y, Jehl F, et al. Clinical pharmacokinetics of voriconazole. Int J Antimicrob Agents 2006; 27 (4): 274-84.
19. Theuretzbacher U, Ihle F, Derendorf H. Pharmacokinetic/pharmacodynamic profile of voriconazole. Clin Pharmacokinet 2006; 45 (7): 649-63. (Pubitemid 43990568)
20. Freifeld A, Arnold S, Ooi W, et al. Relationship of blood level and suscepti- bility in voriconazole treatment of histoplasmosis. Antimicrob Agents Che-mother 2007; 51 (7): 2656-7. (Pubitemid 47047362)
21. Potoski BA, Brown J. The safety of voriconazole. Clin Infect Dis 2002; 35 (10): 1273-5.
22. Denning DW, Ribaud P, Milpied N, et al. Efficacy and safety of voriconazole in the treatment of acute invasive aspergillosis. Clin Infect Dis 2002; 34 (5): 563-71. (Pubitemid 34165316)
23. Tan K, Brayshaw N, Tomaszewski K, et al. Investigation of the potential relationships between plasma voriconazole concentrations and visual adverse eventsor liver function test abnormalities. J Clin Pharmacol 2006;46(2): 235-43. (Pubitemid 43146453)
24. Johnson HJ, Han K, Capitano B, et al. Voriconazole pharmacokinetics in liver transplant recipients. Antimicrob Agents Chemother 2010 Feb; 54 (2): 852-9.
25. Han K, Capitano B, Bies R, et al. Bioavailability and population pharmaco- kinetics of voriconazole in lung transplant recipients. Antimicrob Agents Chemother 2010 Oct; 54 (10): 4424-31.
26. Karlsson MO, Lutsar I, Milligan PA. Population pharmacokinetic analysis of voriconazole plasma concentration data from pediatric studies. Antimicrob Agents Chemother 2009; 53 (3): 935-44.
27. Nomura K, Fujimoto Y, Kanbayashi Y, et al. Pharmacokinetic-pharmaco- dynamic analysis of voriconazole in Japanese patients with hematological malignancies. Eur J Clin Microbiol Infect Dis 2008; 27 (11): 1141-3.
28. Walsh TJ, Karlsson MO, Driscoll T, et al. Pharmacokinetics and safety of intravenous voriconazole in children after single- or multiple-dose administration. Antimicrob Agents Chemother 2004; 48 (6): 2166-72. (Pubitemid 38691615)
29. Pfizer Inc. Vfend® IV (voriconazole) for injection, Vfend® tablets (voriconazole), Vfend® (voriconazole) for oral suspension [L AB-0271-12]. New York: Pfizer Inc., 2005 Mar [online]. Available from URL: http://www.accessdata.fda.gov/drugs atfda-docs/label/2005/021266s013,021267s012, 021630s006lbl.pdf [Accessed 2010 Nov 30].
30. Andes D, Marchillo K, Stamstad T, et al. In vivo pharmacokinetics and pharmacodynamics of a new triazole, voriconazole, in a murine candidiasis model. Antimicrob Agents Chemother 2003; 47 (10): 3165-9. (Pubitemid 37229574)
31. Bowers LD, Canafax DM. Cyclosporine: experience with therapeutic mon- itoring. Ther Drug Monit 1984; 6 (2): 142-7. (Pubitemid 14120791)
32. Christenson JT, Schmuziger M, Maurice J, et al. Postoperative visceral hy- potension the common cause for gastrointestinal complications after cardiac surgery. Thorac Cardiovasc Surg 1994; 42 (3): 152-7. (Pubitemid 24214403)
33. Kennedy JM, Riji AM. Effects of surgery on the pharmacokinetic parameters of drugs. Clin Pharmacokinet 1998; 35 (4): 293-312. (Pubitemid 28491215)
34. Zheyu C, Lunan Y. Early changes of small intestine function in rats after liver transplantation. Transplant Proc 2006; 38 (5): 1564-8.
35. Jeu L, Piacenti FJ, Lyakhovetskiy AG, et al. Voriconazole. Clin Ther 2003; 25 (5): 1321-81. (Pubitemid 36677282)
36. Robatel C, Rusca M, Padoin C, et al. Disposition of voriconazole during continuous veno-venous haemodiafiltration (CVVHDF) in a single patient. J Antimicrob Chemother 2004; 54 (1): 269-70. (Pubitemid 39029007)
37. Lazarus HM, Blumer JL, Yanovich S, et al. Safety and pharmacokinetics of oral voriconazole in patients at risk of fungal infection: a dose escalation study. J Clin Pharmacol 2002; 42 (4): 395-402. (Pubitemid 34259773)
38. Purkins L, Wood N, Ghahramani P, et al. Pharmacokinetics and safety of voriconazole following intravenous- to oral-dose escalation regimens. Anti-microb Agents Chemother 2002; 46 (8): 2546-53. (Pubitemid 34793462)
39. Rengelshausen J, Banfield M, Riedel KD, et al. Opposite effects of short-term and long-term St John's wort intake on voriconazole pharmacokinetics. Clin Pharmacol Ther 2005; 78 (1): 25-33. (Pubitemid 40956928)
40. European Medicines Agency. Vfend: summary of product characteristics [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/document- library/EPAR-Product-Information/human/000387/WC500049756.pdf [Accessed 2010 Nov 30].
41. Antiviral Drugs Advisory Committee, US FDA. Briefing document for vori- conazole (oral and intravenous formulations) [online]. Available from URL: www.fda.gov/ohrms/dockets/ac/01/briefing/3792b2-01-pfizer.pdf [Accessed 2010 Nov 30].
42. Touw DJ, Neef C, Thomson AH, et al. Cost-effectiveness of therapeutic drug monitoring: a systematic review. Ther Drug Monit 2005; 27 (1): 10-7 (Pubitemid 40189967)