NONMEM population pharmacokinetic modeling of orally administered cyclosporine from routine drug monitoring data after heart transplantation

Therapeutic Drug Monitoring

Volumn 20, Issue 3, 1998, Pages 284-293

  Parke, John ^a   Charles, Bruce G ^b  

^a THE PRINCE CHARLES HOSPITAL   (Australia)

^b UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

Cyclosporine; Drug monitoring; Heart transplantation; NONMEM; Population pharmacokinetics

Indexed keywords

AZATHIOPRINE; CYCLOSPORIN A; DILTIAZEM; PREDNISONE;

ADULT; ARTICLE; CLINICAL TRIAL; COMPARTMENT MODEL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CAPSULE; DRUG CLEARANCE; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MECHANISM; DRUG MIXTURE; DRUG MONITORING; FEMALE; GRAFT REJECTION; HEART TRANSPLANTATION; HUMAN; MAJOR CLINICAL STUDY; MALE; ORAL DRUG ADMINISTRATION; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADMINISTRATION, ORAL; ADULT; AGED; BIOLOGICAL AVAILABILITY; CYCLOSPORINE; DRUG MONITORING; FEMALE; HEART TRANSPLANTATION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LINEAR MODELS; MALE; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; RETROSPECTIVE STUDIES; TIME FACTORS;

EID: 0031838725     PISSN: 01634356     EISSN: None     Source Type: Journal    
DOI: 10.1097/00007691-199806000-00008     Document Type: Article

References (46)

1. Ptachcinski RJ, Venkataramanan R, Burckart GJ, et al. Clinical pharmacokinetics of cyclosporine. Clin Pharmacokinet 1986;11: 107-32.
2. Shaw LM, Bowers L, Demers L, et al. Critical issues in cyclosporine monitoring: report of the task force on cyclosporine monitoring Clin Chem 1987;33:1269-88.
3. Lindholm A, Henricsson S, Lind M, Dahlqvist R. Intraindividual variability in the relative systemic availability of cyclosporine after oral dosing. Eur J Clin Pharmacol 1988;34:461-4.
4. Kahan BD, Kramer WG, Wideman C, Flechner SM, Lorber MI, van Buren CT. Demographic factors affecting the pharmacokinetics of cyclosporin A estimated by radioimmunoassay. Transplantation 1984;41:459-64.
5. Tufveson G, Odlind B, Sjöberg O, et al. A longitudinal study of the pharmacokinetics of cyclosporine A and in vitro lymphocyte responses in renal transplant patients. Transplant Proc 1986;18 (suppl 5):16-24.
6. Kahan BD, Wideman CA, Reid M , et al. The value of serial serum trough cyclosporine levels in human renal transplantation. Transplant Proc 1984;16:1195-9.
7. Lindholm A, Dahlqvist R, Groth CG, Sjöqvist F. A prospective study of cyclosporine concentration in relation to its therapeutic effect and toxicity after renal transplantation. Br J Clin Pharmacol 1990;30:443-52.
8. Keown PA, Ulan RA, Wall WJ, et al. Immunological and pharmacological monitoring in the clinical use of cyclosporine A. Lancet 1981;1:686-9.
9. Lindholm A, Kahan BD. Influence of cyclosporine pharmacokinetics, trough concentrations and AUC monitoring on outcome after kidney transplantation. Clin Pharmacol Ther 1993;54:205-18.
10. Grevel J, Welsh MS, Kahan BD. Cyclosporin monitoring in renal transplantation: area under the curve monitoring is superior to trough-level monitoring. Ther Drug Monit 1989;11:246-8.
11. Sheiner LB, Rosenberg B, Marathe VV. Estimation of population characteristics of pharmacokinetic parameters from routine clinical data. J Pharmacokinet Biopharm 1977;5:445-79.
12. Whiting B, Kelman A, Grevel J. Population pharmacokinetics: theory and applications. Clin Pharmacokinet 1986;11:387-401.
13. Sheiner LB, Ludden TM. Population pharmacokinetics/dynamics. Ann Rev Pharmacol Toxicol 1992;32:185-209.
14. Venkataramanan R, Burckart GJ, Ptachcinski RJ, Lee A, Hardisty RL, Griffith BP. Cyclosporine pharmacokinetics in heart transplant patients. Transplant Proc 1986;18:768-70.
15. Myre SA, Schre TJ, Melvin TB, et al. Use of cyclosporine by constant rate infusion immediately after heart transplantation. Transplant Proc 1988;20:316-22.
16. Psalm P, Morris RLG, Taylor PJ, Davis DE, Ravenscroft PJ. A reliable high-performance liquid chromatography assay for high-throughput routine cyclosporin A monitoring in whole blood. Ther Drug Monit 1993;15:65-9.
17. Boeckmann AJ, Sheiner LB, Beal SL. NONMEM Users Guide. San Francisco: Regents of the University of California, 1992.
18. Lee TC, Charles BG, Steer PA, Flenady V, Grant T. Theophylline population pharmacokinetics and oral bioavailability in very low birth weight infants with apnoea of prematurity. Br J Clin Pharmacol 1996;41:191-200.
19. Triggs E, Charles B, Contin M, et al. Population pharmacokinetics and pharmacodynamics of oral levodopa in parkinsonian patients. Eur J Clin Pharmacol 1996;51:59-67.
20. Mandema JW, Verotta D, Sheiner LB. Building population pharmacokinetic-pharmacodynamic models, I: Models for covariate effects. J Pharmacokinet Biopharm 1192;20:511-28.
21. Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm 1981;9:503-13.
22. Gupta SK, Legg B, Solomon LR, Johnson RWG, Rowland M. Pharmacokinetics of cyclosporin: influence of rate constant of constant intravenous infusion in renal transplant patients. Br J Clin Pharmacol 1987;24:519-26.
23. Karlsson MO, Lindberg-Freijs A. Comparison of methods to calculate cyclosporine A bioavailability from consecutive oral and intravenous doses. J Pharmacokinet Biopharm 1990;18:293-311.
24. Drew J, Beglinger C, Kissel T. The absorption site of cyclosporin in the human gastrointestinal tract. Br J Clin Pharmacol 1992;33: 39-43.
25. Lindholm A. Factors influencing the pharmacokinetics of cyclosporine in man. Ther Drug Monit 1991;13:465-77.
26. Christenson JT, Schmuziger M, Maurice J, Simonet F, Velebit, V. Postoperative visceral hypotension the common cause for gastrointestinal complications after cardiac surgery. Thorac Cardiovasc Surg 1994;42:152-7.
27. Bowers LD, Canafax DM. Cyclosporine: Experience with therapeutic monitoring. Ther Drug Monit 1984;6:142-7.
28. Mehta MU, Venkataramanan R, Burckart GJ, et al. Effect of bile on cyclosporin absorption in liver transplant patients. Br J Clin Pharmacol 1988;25:579-84.
29. Progress in pharmacology and clinical pharmacology. In: Sigers C, Watkins J, eds. Biliary Excretion of Drugs and Other Chemicals. New York: Gustav Fischer Ferlag/VCH Publishers, 1991; 8:454-73.
30. Bluhm RE, Rodgers WH, Black DL, Wilkinson GR, Branch R. Cholestasis in transplant patients: What is the role of cyclosporin? Aliment Pharmacol Ther 1992;6:207-19.
31. Schade RR, Guglielmi A, Van Thiel DH, et al. Cholestasis in heart transplant recipients treated with cyclosporine. Transplant Proc 1983;15(suppl 1):2757-60.
32. Freeman DJ, Laupacis A, Keown PA, Stiller CR, Carruthers SG. Evaluation of cyclosporin-phenytoin interaction with observations on cyclosporin metabolites. Br J Clin Pharmacol 1984;18:887-93.
33. Rowland M, Gupta SK. Cyclosporin-phenytoin interaction: reevaluation using metabolite data. Br J Clin Pharmacol 1987;24: 329-34.
34. Simmonds MB, Lythall DA, Slorach C, Ilsley CD, Mitchell AG, Yacoub MH. Doppler examination of superior vena cava flow for the detection of acute cardiac rejection. Circulation 1992;86:259-66.
35. Benet LZ, Greither A, Meister W. Gastrointestinal absorption of drugs in patients with cardiac failure. In: Benet LZ, ed. The effect of disease states on drug pharmacokinetics. Washington: American Pharmaceutical Association/Academy of Pharmaceutical Sciences, 1976:33-50.
36. Wu CY, Benet LZ, Hebert MF, et al. Differentiation of absorption and first-pass gut and hepatic metabolism in human: Studies with cyclosporine. Clin Pharmacol Ther 1995;58:492-7.
37. Min DI, Hwang GC, Bergstrom S, et al. Bioavailability and patient compliance of cyclosporine soft gelatin capsules in renal allograft recipients. Ann Pharmacother 1992;26:175-9.
38. Phillips TM, Karmi SA, Frantz SC, Henriques HF. Absorption profiles of renal allograft recipients receiving oral doses of cyclosporine: A pharmacokinetic study. Transplant Proc 1988;20:457-61.
39. Honcharik N, Yatscoff RW, Jeffery JR, Rush DN. The effect of meal composition on cyclosporine absorption. Transplantation 1991;52:1087-9.
40. Grevel J, Post BK, Kahan BD. Michaelis-Menten kinetics determine cyclosporine steady-state concentrations: A population analysis in kidney transplant patients. Clin Pharmacol Ther 1993; 53:651-60.
41. Maurer G. Metabolism of cyclosporine. Transplant Proc 1985;17 (suppl 1):19-26.
42. Follath F, Wenk M, Vozeh S, et al. Intravenous cyclosporine kinetics in renal failure. Clin Pharmacol Ther 1983;24:638-43.
43. Grevel J, Reynolds KL, Rutzky LP, Kahan BD. Influence of demographic factors on cyclosporine pharmacokinetics in adult uremic patients. J Clin Pharmacol 1989;29:261-6.
44. Reymond J-P. Steimer J-L, Viederberger W. On the dose dependency of cyclosporin A absorption and disposition in healthy volunteers. J Pharmacokinet Biopharm 1988;16:331-53.
45. Masri MA, Shakuntala V, Shanwaz M, et al. Pharmacokinetics of cyclosporine in renal transplant patients on diltiazem. Transplant Proc 1994;26:192.
46. Shennib H, Auger J-L. Diltiazem improves cyclosporine dosage in cystic fibrosis lung transplant patients. J Heart Lung Transplant 1994;13:292-6.