Low intraindividual variability of cyclosporin A exposure reduces chronic rejection incidence and health care costs

Journal of the American Society of Nephrology

Volumn 11, Issue 6, 2000, Pages 1122-1131

  Kahan, Barry D ^a   Welsh, Maria ^a   Urbauer, Diana L ^b   Mosheim, Melinda B ^a   Beusterien, Kathleen M ^c   Wood, Martha R ^c   Schoenberg, Linda P ^a   Dicesare, Joseph ^d   Katz, Stephen M ^a   Van Buren, Charles T ^a  

^a UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

^b Biometrics Consulting   (United States)

^c UK   (United States)

^d NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

AZATHIOPRINE; CYCLOSPORIN A; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PREDNISONE;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; DRUG BLOOD LEVEL; DRUG FORMULATION; FLUORESCENCE POLARIZATION IMMUNOASSAY; FOLLOW UP; GRAFT REJECTION; HEALTH CARE COST; HUMAN; INCIDENCE; KIDNEY BIOPSY; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; RECEIVER OPERATING CHARACTERISTIC;

EID: 0034091294     PISSN: 10466673     EISSN: None     Source Type: Journal    
DOI: 10.1681/asn.v1161122     Document Type: Article

References (40)

1. Borel JF: Pharmacology of cyclosporin. IV. Pharmacological properties in vivo. Pharmacol Rev 41: 259-371, 1990
2. Kahan BD. Cyclosporine. N Engl J Med 321: 1725-1738, 1989
3. Kahan BD: Overview: Individualization of cyclosporine therapy using pharmacokinetic and pharmacodynamic parameters. Transplantation 40: 457-476, 1985
4. Bowers LD: Therapeutic monitoring for cyclosporine: Difficulties in establishing a therapeutic window. Clin Biochem 24: 81-87, 1991
5. Kahan BD, Grevel J: Overview: Optimization of cyclosporine therapy in renal transplantation by a pharmacokinetic strategy. Transplantation 46: 631-644, 1988
6. Kasiske BL, Heim-Duthoy K, Rao KV, Awni WM: The relation between cyclosporine pharmacokinetic parameters and subsequent acute rejection in renal transplant recipients. Transplantation 46: 716-722, 1988
7. Lindholm A, Kahan BD: Influence of cyclosporine pharmacokinetics, trough concentrations, and AUC monitoring on outcome after kidney transplantation. Clin Pharmacol Ther 54: 205-218, 1993
8. Meyer MM, Munar M, Udeaja J, Bennett W: Efficacy of area under the curve monitoring in renal transplantation. J Am Soc Nephrol 4: 1306-1315, 1993
9. Kahan BD, Welsh M, Rutzky LP: Challenges in cyclosporine therapy: The role of therapeutic drug monitoring by area under the curve monitoring. Ther Drug Monit 17: 621-624, 1995
10. Kahan BD, Welsh M, Schoenberg L, Rutzky LP, Katz SM, Urbauer DL: Variable oral absorption of cyclosporine: A biopharmaceutical risk factor for chronic renal allograft rejection. Transplantation 62: 599-606, 1996
11. Beck JR, Schultz EK: The use of relative operating characteristic (ROC) curves in test performance evaluation. Arch Pathol Lab Med 110: 13-20, 1986
12. Browne B, Kahan BD: Renal transplantation. In: Surgical Clinics of North America: Horizons in Transplantation, edited by Kahan BD, Philadelphia, Saunders, 1994, pp 1097-1116
13. Lindholm A, Napoli K, Rutzky L, Kahan BD: Specific monoclonal radioimmunoassay and fluorescence polarization immunoassay for trough concentration and area-under-the-curve monitoring of cyclosporine in renal transplantation. Ther Drug Monit 14: 292-300, 1992
14. Kahan BD, Welsh M, Rutzky L, Lewis R, Knight R, Katz S: The ability of pretransplant test-dose pharmacokinetic profiles to reduce early adverse events after renal transplantation. Transplantation 53: 345-351, 1992
15. Chueh SC, Kahan BD: Pretransplant test-dose pharmacokinetic profiles: Cyclosporine microemulsion versus corn oil-based soft gel capsule formulation. J Am Soc Nephrol 9: 297-304, 1998
16. Dunn J, Grevel J, Napoli K, Lewis RM, Van Buren CT, Kahan BD: The impact of steady-state cyclosporine concentrations on renal allograft outcome. Transplantation 49: 30-34, 1990
17. Gibaldi M: Biopharmaceutics and Clinical Pharmacokinetics. Philadelphia, Lea and Febiger, 1991
18. Lindholm A, Welsh M, Rutzky L, Kahan BD: The adverse impact of high cyclosporine clearance rates on the incidences of acute rejection and graft loss. Transplantation 55: 985-993, 1993
19. Benet LZ, Galeazzi RL: Noncompartmental determination of the steady-state volume of distribution. J Pharmacol Sci 68: 1071-1074, 1979
20. Health Care Financing Administration: Federal Register 61: 59556-59716, November 1996
21. IRP Systems: IRP ICD-9-CM to CPT-4 Cross-Walk of Database as of October 1, 1997, IRP Systems, Inc., Wilmington, MA, 1984-1997
22. Ambulatory Patient Groups Definitions Manual, version 2.0, Wallingford, CT, 3M Health Information Systems, 1997
23. Health Care Financing Administration: Clinical Diagnostic Laboratory Fee Schedule, National/Carrier, 1996
24. Metz CE: Basic principles of ROC analysis. Semin Nucl Med 8: 283-298, 1978
25. Agresti A: Categorical Data Analysis, New York, John Wiley and Sons, 1990
26. Elandt-Johnson RC, Johnson NL: Survival Models and Data Analysis, New York, John Wiley and Sons, 1990
27. Burke JF Jr, Pirsch JD, Ramos EL, Salomon DR, Stablein DM, Van Buren DH: Long-term efficacy and safety of cyclosporine in renal transplant recipients. N Engl J Med 331: 358-363, 1994
28. Tillius SG, Tilney NL: Both alloantigen-dependent and -independent factors influence chronic allograft rejection. Transplantation 59: 313-318, 1995
29. Batiuk TD, Feldzgeritta P, Halloran PF: Calcineurin activity is only partially inhibited in leukocytes of cyclosporine-treated patients. Transplantation 59: 1400-1404, 1995
30. Vozeh S, Kewitz G, Perruchoud A, Tschan M, Kopp C, Heitz M: Theophylline serum concentration and therapeutic effect in severe acute bronchial obstruction: The optimal use of intravenously administered aminophylline. Am Rev Respir Dis 125: 181-184, 1982
31. Holt DW, Marsden JT, Johnston A, Bewick M, Taube DH: Blood cyclosporine concentrations and renal allograft dysfunction. Br Med J 293: 1057-1059, 1986
32. Best NG, Trull AK, Tan KK, Hue KL: Blood cyclosporin concentrations and the short-term risk of lung rejection following heart-lung transplantation. Br J Clin Pharmacol 34: 513-520, 1992
33. Savoldi S, Maiorca R, Maderna M, Chiappini R, Corbetta G: Low intrapatient variability of blood cyclosporine levels is correlated with excellent graft survival. Transplant Proc 29: 288-289, 1997
34. Sanathanan LP, Peck CC: The randomized concentration-controlled trial: An evaluation of its sample size efficiency. Controlled Clin Trials 12: 780-794, 1991
35. Watkins PB, Murray SA, Winkelman LG, Heuman DM, Wrighton SA, Guzelian PS: Erythromycin breath test as an assay of glucocorticoid-inducible liver cytochromes P-450: Studies in rats and patients. J Clin Invest 83: 688-697, 1989
36. Rodman JH: Pharmacokinetic variability in the adolescent: Implications of body size and organ function for dosage regimen design. J Adolesc Health 15: 654-662, 1994
37. Sollinger HW: Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. U.S. Renal Transplant Mycophenolate Mofetil Study Group. Transplantation 60: 225-232, 1995
38. Kahan BD, Podbielski J, Napoli KL, Katz SM, Meier-Kriesche HU, Van Buren CT: Immunosuppressive effects and safety of a sirolimus/cyclosporine combination regimen for renal transplantation. Transplantation 66: 1040-1046, 1998
39. Kahan BD, Dunn J, Fitts C, Van Buren D, Wombolt D, Pollak R: 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, 1995
40. Kingma I, Ludwin D, Dandavino R: Economic analysis of Neoral in de novo renal transplant patients in Canada. Clin Transplant 11: 42-48, 1997