Time-dependent changes in cyclosporine exposure: Implications for achieving target concentrations

Transplant International

Volumn 16, Issue 7, 2003, Pages 494-503

  Rosso Felipe, Claudia ^a   Tedesco Silva, Helio ^a   Pinheiro Machado, Paula Goulart ^a   Garcia, Riberto ^a   Da Silva Moreira, Silvia Regina ^a   Medina Pestana, José Osmar ^a  

^a FEDERAL UNIVERSITY OF SÃO PAULO   (Brazil)

Author keywords

Cyclosporine; Kidney transplantation; Pharmacokinetics; Therapeutic drug monitoring

Indexed keywords

CYCLOSPORIN;

ADULT; ARTICLE; BIOAVAILABILITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; ETHNOLOGY; FEMALE; GRAFT REJECTION; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; INCIDENCE; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; STEADY STATE;

ADULT; AREA UNDER CURVE; CYCLOSPORINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG MONITORING; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; OSMOLAR CONCENTRATION; POSTOPERATIVE CARE; TREATMENT OUTCOME;

EID: 0042026823     PISSN: 09340874     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00147-003-0573-7     Document Type: Article

References (43)

1. Amante AJ, Meier-Kriesche HU, Schoenberg L, Kahan BD (1997) A pharmacokinetic comparison of the corn oil versus microemulsion gelcap formulation of cyclosporine used de novo after renal transplantation. Transpl Int 10:217-222
2. Awni WM, Kasiske BL, Heim-Duthoy K, Rao KV (1989) Long-term cyclosporine pharmacokinetic changes in renal transplant recipients: effects of binding and metabolism. Clin Pharmacol Ther 45:41-48
3. Barone G, Chang CT, Choc MG Jr, Klein JB, Marsh CL, Meligeni JA, Min DI, Pescovitz MD, Pollak R, Pruett TL, Stinson JB, Thompson JS, Vasquez E, Waid T, Wombolt DG, Wong RL (1996) The pharmacokinetics of a microemulsion formulation of cyclosporine in primary renal allograft recipients. The Neoral Study Group. Transplantation 61:875-880
4. Belitsky P, Dunn S, Johnston A, Levy G (2000) Impact of absorption profiling on efficacy and safety of cyclosporine therapy in transplant recipients. Clin Pharmacokinet 39:117-125
5. Brunner LJ, Bennett WM, Koop DR (1998) Cyclosporine suppresses rat hepatic cytochrome P450 in a time-dependent manner. Kidney Int 54:216-223
6. Choudhury S, Kahan B, Leichtman A, Ferguson R, Karlix J, Schmouder RLC, Sablinski T (2000) Absorption and disposition of multiple dose FTY720 in humans (abstract no. 183). Transplantation 69:S160
7. Chueh SC, Kahan BD (1998) Pretransplant test-dose pharmacokinetic profiles: cyclosporine microemulsion versus corn oil-based soft gel capsule formulation. J Am Soc Nephrol 9:297-304
8. Curtis J, Nashan B, Ponticelli C (2001) A multicenter randomized, open-label, parallel-group study evaluating the efficacy and safety of everolimus (RAD) given with basiliximab, corticosteroids, and either full- or reduced-dose cyclosporine in de novo renal transplant patients (abstract no. 1335). Am J Transplant 1 [Suppl 1]:474
9. David O, Johnston A (2000) Limited sampling strategies. Clin Pharmacokinet 39:311-313
10. Dumont RJ, Ensom MH (2000) Methods for clinical monitoring of cyclosporine in transplant patients. Clin Pharmacokinet 38:427-447
11. Grevel J, Post BK, Kahan BD (1993) Michaelis-Menten kinetics determine cyclosporine steady-state concentrations: a population analysis in kidney transplant patients. Clin Pharmacol Ther 53:651-660
12. Gubbins PO, Bertch KE (1991) Drug absorption in gastrointestinal disease and surgery. Clinical pharmacokinetic and therapeutic implications. Clin Pharmacokinet 21:431-447
13. Hebert MF (1997) Contributions of hepatic and intestinal metabolism and P-glycoprotein to cyclosporine and tacrolimus oral drug delivery. Adv Drug Deliv Rev 27:201-214
14. Hoyer PF (1998) Cyclosporin A (Neoral) in pediatric organ transplantation. Neoral Pediatric Study Group. Pediatr Transplant 2:35-39
15. Johnston A, Kovarik JM, Mueller EA, Holt DW (1996) Predicting patients' exposure to cyclosporine. Transpl Int 9 [Suppl 1]: S305-S307
16. Kahan BD (2000) Efficacy of sirolimus compared with azathioprine for reduction of acute renal allograft rejection: a randomised multicentre study. The Rapamune US Study Group. Lancet 356:194-202
17. Kahan BD, Dunn J, Fitts C, Van Buren D, Wombolt D, Pollak R, Carson R, Alexander JW, Choc M, Wong R (1995) Reduced inter- and intrasubject variability in cyclosporine pharmacokinetics in renal transplant recipients treated with a microemulsion formulation in conjunction with fasting, low-fat meals, or high-fat meals. Transplantation 59:505-511
18. Kahan BD, Welsh M, Schoenberg L, Rutzky LP, Katz SM, Urbauer DL, Van Buren CT (1996) Variable oral absorption of cyclosporine. A biopharmaceutical risk factor for chronic renal allograft rejection. Transplantation 62:599-606
19. Kahan BD, Welsh M, Urbauer DL, Mosheim MB, Beusterien KM, Wood MR, Schoenberg LP, Dicesare J, Katz SM, Van Buren CT (2000) Low intraindividual variability of cyclosporin A exposure reduces chronic rejection incidence and health care costs. J Am Soc Nephrol 11:1122-1131
20. Kasiske BL, Heim-Duthoy K, Rao KV, Awni WM (1988) The relationship between cyclosporine pharmacokinetic parameters and subsequent acute rejection in renal transplant recipients. Transplantation 46:716-722
21. Keown P, Niese D (1998) Cyclosporine microemulsion increases drug exposure and reduces acute rejection without incremental toxicity in de novo renal transplantation. International Sandimmun Neoral Study Group. Kidney Int 54:938-944
22. Keown P, Landsberg D, Halloran P, Shoker A, Rush D, Jeffery J, Russell D, Stiller C, Muirhead N, Cole E, Paul L, Zaltzman J, Loertscher R, Daloze P, Dandavino R, Boucher A, Handa P, Lawen J, Belitsky P, Parfrey P (1996) A randomized, prospective multicenter pharmacoepidemiologic study of cyclosporine microemulsion in stable renal graft recipients. Report of the Canadian Neoral Renal Transplantation Study Group. Transplantation 62:1744-1752
23. Kovarik JM, Mueller EA, Bree JB van, Fluckiger SS, Lange H, Schmidt B, Boesken WH, Lison AE, Kutz K (1994) Cyclosporine pharmacokinetics and variability from a microemulsion formulation - a multicenter investigation in kidney transplant patients. Transplantation 58:658-663
24. Kovarik JM, Mueller EA, Bree JB van, Tetzloff W, Kutz K (1994) Reduced inter- and intraindividual variability in cyclosporine pharmacokinetics from a microemulsion formulation. J Pharm Sci 83:444-446
25. Kovarik JM, Mueller EA, Niese D (1996) Clinical development of a cyclosporine microemulsion in transplantation, Ther Drug Monit 18:429-434
26. Kovarik JM, Mueller EA, Richard F, Niese D, Halloran PF, Jeffery J, Paul LC, Keown PA (1996) Evidence for earlier stabilization of cyclosporine pharmacokinetics in de novo renal transplant patients receiving a microemulsion formulation. Transplantation 62:759-763
27. Kovarik JM, Kaplan B, Tedesco Silva H, Kahan BD, Dantal J, Vitko S, Boger R, Rordorf C (2002) Exposure-response relationships for everolimus in de novo renal transplantation: defining a therapeutic range. Transplantation 73:920-925
28. Lampen A, Christians U, Bader A, Hackbarth I, Sewing KF (1996) Drug interactions and interindividual variability of cyclosporine metabolism in the small intestine. Pharmacology 52:159-168
29. Lindholm A, Kahan BD (1993) Influence of cyclosporine pharmacokinetics, trough concentrations, and AUC monitoring on outcome after kidney transplantation. Clin Pharmacol Ther 54:205-218
30. Lown KS, Mayo RR, Leichtman AB, Hsiao HL, Turgeon DK, Schmiedlin-Ren P, Brown MB, Guo W, Rossi SJ, Benet LZ, Watkins PB (1997) Role of intestinal P-glycoprotein (mdrl) in interpatient variation in the oral bioavailability of cyclosporine. Clin Pharmacol Ther 62:248-260
31. MacDonald AS (2001) A worldwide, phase III, randomized, controlled, safety and efficacy study of a sirolimus/cyclosporine regimen for prevention of acute rejection in recipients of primary mismatched renal allografts. Transplantation 71:271-280
32. Mahalati K, Kahan BD (2000) Pharmacological surrogates of allograft outcome. Ann Transplant 5:14-23
33. Mahalati K, Belitsky P, Sketris I, West K, Panek R (1999) Neoral monitoring by simplified sparse sampling area under the concentration-time curve: its relationship to acute rejection and cyclosporine nephrotoxicity early after kidney transplantation. Transplantation 68:55-62
34. Mahalati K, Belitsky P, West K, Kiberd B, Fraser A, Sketris I, Macdonald AS, McAlister V, Lawen J (2001) Approaching the therapeutic window for cyclosporine in kidney transplantation: a prospective study. J Am Soc Nephrol 12:828-833
35. Medeiros M, Perez-Urizar J, Munoz R, Castaneda-Hernandez G (1999) Limited sampling model for area-under-the-curve monitoring in pediatric patients receiving either Sandimmun or Neoral cyclosporin A oral formulations. Pediatr Transplant 3:225-230
36. Meyer MM, Munar M, Udeaja J, Bennett W (1993) Efficacy of area under the curve cyclosporine monitoring in renal transplantation. J Am Soc Nephrol 4:1306-1315
37. Mueller EA, Kovarik JM, Bree JB van, Lison AE, Kutz K (1994) Pharmacokinetics and tolerability of a microemulsion formulation of cyclosporine in renal allograft recipients - a concentration-controlled comparison with the commercial formulation. Transplantation 57:1178-1182
38. Mueller EA, Kovarik JM, Bree JB van, Tetzloff W, Grevel J, Kutz K (1994) Improved dose linearity of cyclosporine pharmacokinetics from a microemulsion formulation. Pharm Res 11:301-304
39. Mueller EA, Kallay Z, Kovarik JM, Richard F, Wiesinger O, Schmidt K, Scheele J (1995) Bile-independent absorption of cyclosporine from a microemulsion formulation in liver transplant patients. Transplantation 60:515-517
40. Primmett DR, Levine M, Kovarik JM, Mueller EA, Keown PA (1998) Cyclosporine monitoring in patients with renal transplants: two- or three-point methods that estimate area under the curve are superior to trough levels in predicting drug exposure. Ther Drug Monit 20:276-283
41. Shah MB, Martin JE, Schroeder TJ, Roy First M (1999) The evaluation of the safety and tolerability of two formulations of cyclosporine: Neoral and Sandimmun. Transplantation 67:1411-1417
42. Shaw LM, Holt DW, Keown P, Venkataramanan R, Yatscoff RW (1999) Current opinions on therapeutic drug monitoring of immunosuppressive drugs. Clin Ther 21:1632-1652
43. Valantine H (2000) Neoral use in the cardiac transplant recipient. Transplant Proc 32:27S-44S