Cyclosporine microemulsion (Neoral®) absorption profiling and sparse-sample predictors during the first 3 months after renal transplantation

American Journal of Transplantation

Volumn 2, Issue 2, 2002, Pages 148-156

  Keown, Paul ^a,h   Cole, E ^b,j   Muirhead, N ^c   Romanet, T ^d   Citterio, F ^e   Backman L ^f   Del Castillo, D ^g   Balshaw, Robert ^h   Prestele, Hans ^h   Beauregard Zollinger, Lyse ^h   Fornairon, Sophie ^h   Murphy, Gerard ^h   Perner, F ^h   Wauters, J P ⁱ  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b UNIVERSITY OF TORONTO   (Canada)

^c UNIVERSITY OF WESTERN ONTARIO   (Canada)

^d HÔPITAL MICHALLON   (France)

^e CATHOLIC UNIVERSITY   (Italy)

^f SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^g HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

^h SEMMELWEIS UNIVERSITY OF MEDICINE   (Hungary)

ⁱ LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^j UNIVERSITY HEALTH NETWORK   (Canada)

more..

Author keywords

Absorption profiling; Basiliximab; Cyclosporine microemulsion (Neoral ); Immune suppression; Kidney; Transplantation

Indexed keywords

BASILIXIMAB; CYCLOSPORIN A; PREDNISONE;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONCENTRATION RESPONSE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG ABSORPTION; DRUG COST; DRUG EFFICACY; FEMALE; GRAFT REJECTION; HUMAN; IMMUNOPROPHYLAXIS; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY TRANSPLANTATION; MALE; MICROEMULSION; MULTICENTER STUDY; PATIENT MONITORING; RECIPIENT; RISK FACTOR;

AREA UNDER CURVE; CADAVER; CAUCASOID RACE; CYCLOSPORINE; EMULSIONS; HUMAN; IMMUNOSUPPRESSIVE AGENTS; INTESTINAL ABSORPTION; KIDNEY TRANSPLANTATION; LIVING DONORS; METABOLIC CLEARANCE RATE; MIDDLE AGE; PATIENT SELECTION; PREDICTIVE VALUE OF TESTS; SAMPLE SIZE; SUPPORT, NON-U.S. GOV'T; TIME FACTORS; TISSUE DONORS;

EID: 0036487978     PISSN: 16006135     EISSN: None     Source Type: Journal    
DOI: 10.1034/j.1600-6143.2002.020206.x     Document Type: Article

References (33)

1. Kahan BD. Individualization of cyclosporine therapy using pharmacokinetic and pharmacodynamic parameters. Transplantation 1985; 40: 457-474.
2. Lindholm A, Henricsson S, Lind M et al. Intraindividual variability in the relative systemic availability of cyclosporine after oral dosing. Eur J Clin Pharmacol 1988; 34: 461-464.
3. Lindholm A. Review factors influencing the pharmacokinetics of cyclosporine in man. Ther Drug Monit 1991; 13: 465-477.
4. Lindholm A, Kahan BD. Influence of cyclosporine pharmacokinetics, trough concentrations, and AUC monitoring on outcome after kidney transplantation. Clin Pharmacol Ther 1993; 54: 205-218.
5. Schroeder TJ, Hariharan S, First MR. Variations in bioavailability of cyclosporine and relationship to clinical outcome in renal transplant subpopulations. Transplant Proc 1995; 27: 837-839.
6. Primmett DRN, Levine M, Wrishko R, Keown PA. A pharmacokinetic study of cyclosporin (Sandimmune®): factors affecting the usefulness of trough levels in predicting drug exposure in renal transplant patients. Clin Drug Invest 1997; 13: 23-36.
7. Holt DW, Johnston A. Pharmacokinetics and monitoring of cyclosporine A. In: Thomson AW, Starzl TE, eds. Immunosuppressive Drugs, Developments in Anti-Rejection Therapy. London: Edward Arnold, 1994: 37-45.
8. Kovarik JM, Mueller EA, Van Bree JB et al. Cyclosporine pharmacokinetics and variability from a microemulsion formulation - a multicenter investigation in kidney transplant patients. Transplantation 1994; 58: 658-663.
9. Kahan BD, Dunn J, Fitts C et al. 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 1995; 59: 505-511.
10. Holt DW, Mueller EA, Kovarik JM et al. The pharmacokinetics of Sandimmun Neoral: a new oral formulation of cyclosporine. In: Kahan BD, ed. Cyclosporine, The Ten-Year Experience. Norwalk Conn: Appleton & Lange; 1994. p. 2935-2939.
11. Levy G, Grant D. Potential for CsA-Neoral in organ transplantation. In: Kahan BD, ed. Cyclosporine, The Ten-Year Experience. Norwalk Conn: Appleton & Lange; 1994. p. 2932-2934.
12. Johnston A, Sketris J, Marsden JT et al. A limited sampling strategy for the measurement of cyclosporine AUC. Transplant Proc 1990; 22: 1345-1346.
13. Serino F, Citterio F, Pozzetto U et al. Abbreviated three-point kinetic profile in the 12-hour area under the curve for pharmacokinetic monitoring of cyclosporine. In: Kahan BD, ed. Cyclosporine, The Ten-Year Experience. Norwalk Conn: Appleton & Lange; 1994. p. 2807-2808.
14. Canadian Neoral Renal Transplantation Study Group. A randomized, prospective multicentre pharmacoepidemiologic study of cyclosporine microemulsion in stable renal graft recipients. Transplantation 1997; 62: 1744-1752.
15. Primmett DRN, Levine M, Kovarik JM, Mueller EA, Keown PA. Cyclosporine monitoring in renal transplant patients: two- or three-point methods that estimate AUC are superior to trough levels in predicting drug exposure. Ther Drug Monit 1998; 20: 276-283.
16. Cantarovich M, Besner JG, Barkun JS, Elstein E, Loertscher R. Twohour cyclosporine level determination is the appropriate tool to monitor Neoral therapy. Clin Transplant 1998; 12: 243-249.
17. Halloran PF, Helms LM, Kung L, Noujaim J. The temporal profile of calcineurin inhibition by cyclosporine in vivo. Transplantation 1999; 68: 1365-1361.
18. Sindhi R, Mariano F, LaVia EP et al. Stimulated response of peripheral lymphocytes may distinguish cyclosporine effect in renal transplant recipients receiving a cyclosporine + rapamycin regimen. Transplantation 2000; 69: 432-436.
19. Canadian Neoral Renal Transplantation Study Group. Absorption profiling of cyclosporine microemulsion (Neoral) during the first two weeks after renal transplantation. Transplantation 2001; 72: 1024-1032.
20. Mahalati K, Belitsky P, Sketris I, West K, Panek R. 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 1999; 68: 55-62.
21. Belitsky P, Mahalati K, West K, Sketris I. Influence of drug formulation on utilization and outcomes: Neoral and monitoring by sparse sample area under the curve. Transplant Proc 1999; 31: 1667-1668.
22. Nashan B, Moore R, Amlot P, Schmidt AG, Abeywickrama K, Soulillou JP. For the CHIB 201 International Study Group. Randomised trial of basiliximab versus placebo for control of acute cellular rejection in renal allograft recipients. Lancet 1997; 350: 1193-1198.
23. Barama A, Perner F, Beauregard-Zollinger L, Prestele H, and the Phase IV Neoral Study Group. Absorption profiling of cyclosporine therapy for de novo kidney transplantation: a prospective, randomized study comparing sparse sampling to trough monitoring. Transplantation 2000; 69: S162.
24. Perner F, Barama A, Rigotti P, for the Phase IV Neoral Study Group. Absorption profiling of cyclosporine therapy for de novo kidney transplantation: a prospective, randomized study comparing sparse sampling to trough monitoring in kidney transplantation. In: XVIII Congress of the Transplantation Society, Rome. 2000; 327: P0617.
25. Crocker JF, Wade AW, McDonald AT et al. Kidney graft loss in children: implications for program development. CMAJ 1998; 159: 229-235.
26. Kahan BD, Welsh M, Schoenberg L et al. Variable oral absorption of cyclosporine. A biopharmaceutical risk factor for chronic renal allograft rejection. Transplantation 1996; 62: 599-606.
27. Matas AJ, Gillingham KJ, Chavers BM et al. The importance of early cyclosporine levels in pediatric kidney transplantation. Clin Transplant 1996; 10: 482-486.
28. Birk PE, Matas AJ, Gillingham KJ, Mauer SM, Najarian JS, Chavers BM. Risk factors for chronic rejection in pediatric renal transplant recipients - a single-center experience. Pediatr Nephrol 1997; 11: 395-398.
29. Lipkowitz GS, Madden RL, Mulhern J et al. Long-term maintenance of therapeutic cyclosporine levels leads to optimal graft survival without evidence of chronic nephrotoxicity. Transpl Int 1999; 12: 202-207.
30. Senel MF, Van Buren CT, Welsh M, Kahan BD. Impact of early cyclosporin average blood concentration on early kidney transplant failure. Transpl Int 1998; 11: 46-52.
31. Keown PA, Niese D, for the International Sandimmun Neoral Study Group. Cyclosporine microemulsion increases drug exposure and reduces acute rejection without incremental toxicity in de novo renal transplantation. Kidney Int 1998; 54: 938-944.
32. Hall SD, Thummel KE, Watkins PB et al. Molecular and physical mechanisms of first-pass extraction. Drug Metab Dispos 1999; 27: 161-166.
33. Wacher VJ, Silverman JA, Zhang Y, Benet LZ. Role of p-glycoprotein and cytochrome P450, 3A in limiting oral absorption of peptides and peptidomimetics. J Pharm Sci 1998; 87: 1322-1330.