Lifetime cost-effectiveness of calcineurin inhibitor withdrawal after de novo renal transplantation

Journal of the American Society of Nephrology

Volumn 19, Issue 9, 2008, Pages 1807-1816

  Earnshaw, Stephanie R ^a,d   Graham, Christopher N ^a   Irish, William D ^a   Sato, Reiko ^b   Schnitzler, Mark A ^c  

^a RTI HEALTH SOLUTIONS   (United States)

^b PFIZER INC   (United States)

^c SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CALCINEURIN INHIBITOR; CYCLOSPORIN A; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; RAPAMYCIN; STEROID; TACROLIMUS; CALCINEURIN; IMMUNOSUPPRESSIVE AGENT;

ARTICLE; COST EFFECTIVENESS ANALYSIS; DRUG COST; DRUG EFFICACY; DRUG USE; DRUG WITHDRAWAL; GRAFT REJECTION; GRAFT SURVIVAL; HUMAN; KIDNEY FUNCTION; KIDNEY TRANSPLANTATION; NEPHROTOXICITY; PRIORITY JOURNAL; SURVIVAL TIME; COST BENEFIT ANALYSIS; DECISION SUPPORT SYSTEM; DONOR; DRUG ANTAGONISM; ECONOMICS; IMMUNOLOGY; IMMUNOSUPPRESSIVE TREATMENT; PROBABILITY; STATISTICAL MODEL;

CALCINEURIN; COST-BENEFIT ANALYSIS; DECISION SUPPORT TECHNIQUES; HUMANS; IMMUNOSUPPRESSION; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MARKOV CHAINS; MODELS, ECONOMIC; SIROLIMUS; TISSUE DONORS;

EID: 54749146451     PISSN: 10466673     EISSN: 15333450     Source Type: Journal    
DOI: 10.1681/ASN.2007040495     Document Type: Article

References (47)

1. Kasiske BL, Vazquez MA, Harmon WE, Brown RS, Danovitch GM, Gaston RS, Roth D, Scandling SD Jr, Singer GG: Recommendations for the outpatient surveillance of renal transplant recipients. J Am Soc Nephrol 11[Suppl 15]: S1-S86, 2000
2. Wolfe RA, Ashby VB, Milford EL, Ojo AO, Ettenger RE, Agodoa LY, Held PJ, Port FK: Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med 341: 1725-1730, 1999
3. Mulay AV, Hussain N, Fergusson D, Knoll BA: Calcineurin inhibitor withdrawal from sirolimus-based therapy in kidney transplantation: A systematic review of randomized trials. Am J Transplant 5: 1748-1756, 2005
4. Kreis H, Oberbauer R, Campistol JM, Mather T, Daloze P, Schena FP, Burke JT, Brault Y, Gioud-Paquet M, Scarola JA, Neylan JF: Long-term benefits with sirolimus-based therapy after early cyclosporine withdrawal. J Am Soc Nephrol 15: 809-817, 2004
5. Oberbauer R, Kreis H, Johnson RW, Mota A, Claesson K, Ruiz JC, Wilczek H, Jamieson N, Henriques AC, Paczek L, Chapman J, Burke JT: Long-term improvement in renal function with sirolimus after early cyclosporine withdrawal in renal transplant recipients: 2-Year results of the Rapamune maintenance regimen study. Transplantation 76: 364-370, 2003
6. Johnson RW, Kreis H, Oberbauer R, Brattstrom C, Claesson K, Eris J: Sirolimus allows early cyclosporine withdrawal in renal transplantation resulting in improved renal function and lower blood pressure. Transplantation 72: 777-786, 2001
7. Mota A, Arias M, Taskinen EI, Paavonen T, Brault Y, Lengendre C, Claesson K, Castagneto M, Campistol JM, Hutchison B, Burke JT, Yilmaz S, Hayry P, Neylan JF: Sirolimus-based therapy following early cyclosporine withdrawal provides significantly improved renal histology and function at 3 years. Am J Transplant 4: 953-961, 2004
8. Oberbauer R, Segoloni G, Campistol JM, Kreis H, Mota A, Lawen J, Russ G, Grinyo JM, Stallone G, Hartmann A, Pinto JR, Chapman J, Burke JT, Brault Y, Neylan JF: Early cyclosporine withdrawal from a sirolimus-based regimen results in better renal allograft survival and renal function at 48 months after transplantation. Transplant Int 18: 22-28, 2005
9. Legendre C, Brault Y, Morales JM, Oberbauer R, Altieri P, Riad H, Mahony J, Messina M, Pussell B, Martinez JG, Lelong M, Burke JT, Neylan JF: Factors influencing glomerular filtration rate in renal transplantation after cyclosporine withdrawal using sirolimus-based therapy: A multivariate analysis of results at five years. Clin Transplant 21: 330-336, 2007
10. Sirolimus [package insert], Philadelphia, Wyeth Pharmaceuticals Inc., 2007
11. US Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients: 2004 Annual Report, Transplant Data 1994-2003, Rockville, Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation, and Richmond, United Network for Organ Sharing, and Ann Arbor, University Renal Research and Education Association, 2004
12. Hariharan S, McBride MA, Cherikh WS, Tolleris CB, Bresnahan BA, Johnson CP: Post-transplant renal function in first year predicts long-term kidney transplant survival. Kidney Int 62: 311-318, 2002
13. US Renal Data System: 2004 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, Bethesda, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2004
14. Weir MR, Ward MT, Blahut SA, Klassen DK, Cangro CB, Bartlett ST, Fink JC: Long-term impact of discontinued or reduced calcineurin inhibitor in patients with chronic allograft nephropathy. Kidney Int 59: 1567-1573, 2001
15. Velosa JA, Larson TS, Gloor JM, Stegall MD: Cyclosporine elimination in the presence of TOR inhibitors: Effects on renal function, acute rejection, and safety. Am J Kidney Dis 38[Suppl 2]: S3-S10, 2001
16. Suwelack B, Gerhardt U, Hohage H: Withdrawal of cyclosporine or tacrolimus after addition of mycophenolate mofetil in patients with chronic allograft nephropathy. Am J Transplant 4: 655-662, 2004
17. Weir MR, Blahut S, Drachenburg C, Young C, Papademitriou J, Klassen DK, Cangro CB, Bartlett ST, Fink JC: Late calcineurin inhibitor withdrawal as a strategy to prevent graft loss in patients with suboptimal kidney transplant function. Am J Nephrol 24: 379-386, 2004
18. Larson TS, Dean PG, Stegall MD, Griffin MD, Textor SC, Schwab TR, Gloor JM, Cosio FG, Lund WJ, Kremers WK, Nyberg SL, Ishitani MB, Prieto M, Velosa JA: Complete avoidance of calcineurin inhibitors in renal transplantation: A randomized trial comparing sirolimus and tacrolimus. Am J Transplant 6: 514-522, 2006
19. Kahn K: Low-dose tacrolimus superior to other immunosuppressives after renal transplant. Available at: http://www.medscape.com/viewarticle/542257. Accessed November 19, 2007
20. Flechner SM, Glyda M, Steinberg S, Copley JB, the ORION Trial Investigators: The efficacy of sirolimus (SRL) and tacrolimus (TAC) withdrawal versus SRL and mycophenolate mofetil (MMF) compared with TAC and MMF in de novo renal allograft recipients: Interim results from the Orion study [abstract]. J Am Soc Nephrol 18: 95A, 2007
21. Gordois A, Nobes M, Tohhey M, Russ G: Cost-effectiveness of sirolimus therapy with early cyclosporine withdrawal vs. long-term cyclosporine therapy in Australia. Clin Transplant 20: 526-536, 2006
22. McEwan P, Baboolal K, Conway P, Currie CJ: Evaluation of the cost-effectiveness of sirolimus versus cyclosporine for immunosuppression after renal transplantation in the United Kingdom. Clin Ther 27: 1834-1846, 2005
23. McEwan P, Dixon S, Baboolal K, Conway P, Currie C: Evaluation of the cost-effectiveness of sirolimus versus tacrolimus for immunosuppression following renal transplantation in the United Kingdom. Pharmacoeconomics 24: 67-79, 2006
24. Jassal SV, Krahn MD, Nagle G, Zaltzman JS, Roscoe JM, Cole EH, Redelmeier DA: Kidney transplantation in the elderly: A decision analysis. J Am Soc Nephrol 14: 187-196, 2003
25. Irish W, Sherrill B, Brennan DC, Lowell J, Schnitzler M: Three-year post-transplant graft survival in renal transplant patients receiving tacrolimus or cyclosporine microemulsion within a triple drug regimen. Transplantation 76: 1686-1690, 2003
26. Bunnapradist S, Takemoto SK: Multivariate analysis of antibody induction therapy and their associated outcomes in deceased donor transplants. Transplant Proc 37: 889-891, 2005
27. Castro MC, Araujo LM, Nahas WC, Arap S, David-Neto E, Ianhez LE: Induction versus noninduction therapy in kidney transplantation: Considering different PRA levels and different induction therapies. Transplant Proc 36: 874-876, 2004
28. Kode R, Fa K, Chowdhury S, Ranganna K, Fyfe B, Stabler S, Damask A, Laftavi MR, Kumar AM, Pankewycz O: Basiliximab plus low-dose cyclosporin vs. OKT3 for induction immunosuppression following renal transplantation. Clin Transplant 17: 369-376, 2003
29. Heifets M, Saeed MI, Parikh MH, Sierka D, Kumar MS: Induction immunosuppression in kidney transplant recipients older than 60 years of age: Safety and efficacy of ATGAM, OKT3 and Simulect. Drugs Aging 21: 747-756, 2004
30. Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B: Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant 4: 378-383, 2004
31. Pascual J, Marcen R, Ortuno J. Renal function: Defining long-term success. Nephrol Dial Transplant 19[Suppl 6]: vi3-vi7, 2004
32. Flechner SM, Goldfarb D, Modline C, Feng J, Krishnamurthi V, Mastroianni B, Savas K, Cook DJ, Novick AC: Kidney transplantation without calcineurin inhibitor drugs: A prospective, randomized trial of sirolimus versus cyclosporine. Transplantation 74: 1213-1220, 2002
33. Ciancio G, Burke GW, Gaynor JJ, Mattiazzi A, Roth D, Kupin W, Nicolas M, Ruiz P, Rosen A, Miller J: A randomized long-term trial of tacrolimus/sirolimus versus tacrolimus/mycophenolate mofetil versus cyclosporine (NEORAL)/sirolimus in renal transplantation, II: Survival, function, and protocol compliance at 1 year. Transplantation 77: 252-258, 2004
34. Kasiske BL, Snyder JJ, Gilbertson D, Matas AJ: Diabetes mellitus after kidney transplantation in the United States. Am J Transplant 3: 178-185, 2003
35. Matas AJ, Schnitzler MA: Payment for living donor (vendor) kidneys: A cost-effectiveness analysis. Am J Transplant 4: 216-221, 2003
36. Schnitzler MA, Whiting JF, Brennan DC, Lin G, Chapman W, Lowell J, Boxerman S, Hardinger KL, Kalo Z: The expanded criteria donor dilemma in cadaveric renal transplantation. Transplantation 75: 1940-1945, 2003
37. US Department of Labor, Bureau of Labor Statistics: Consumer Price Index - All Urban Consumers (Current Series). Available at: http://data.bls.gov/PDQ/ outside.jsp?survey=cu. Accessed July 15, 2006
38. Woodward RS, Schnitzler MA, Baty J, Lowell JA, Lopez-Rocafort L, Haider S, Woodworth TG, Brennan DC: Incidence and cost of new onset diabetes mellitus among U.S. wait-listed and transplanted renal allograft recipients. Am J Transplant 3: 590-598, 2003
39. Surveillance Data Inc.: Rapamune Dosing Study [data on file], Plymouth Meeting, PA, Surveillance Data Inc., 2005
40. Red Book for Windows, version 61127 (CD-ROM), Greenwood Village, CO, Thomson Healthcare
41. Churchill DN, Torrance GW, Taylor DW, Barnes CC, Ludwin D, Shimizu A, Smith EK: Measurement of quality of life of end-stage renal disease: The time trade-off approach. Clin Invest Med 10: 14-20, 1987
42. Laupacis A, Keown P, Pus N, Krueger H, Ferguson B, Wong C, Muirhead N: A study of the quality of life and cost-utility of renal transplantation. Kidney Int 50: 235-242, 1996
43. Mutinga N, Brennan DC, Schnitzler MA: Consequences of eliminating HLA-B in deceased donor kidney allocation to increase minority transplantation. Am J Transplant 5: 1-9, 2005
44. Yen E, Hardinger K, Brennan DC, Woodward RS, Desai NM, Crippin JS, Gage BF, Schnitzler MA: Cost-effectiveness of extending Medicare coverage of immunosuppressive medications to the life of a kidney transplant. Am J Transplant 4: 1703-1708, 2004
45. Gold MR, Siegel JE, Russell LB, Weinstein MC: Cost-Effectiveness in Health and Medicine, New York, Oxford University Press, 1996
46. Meier-Kriesche HU, Steffen BJ, Chu AH, Loveland JL, Gordon RD, Morris JA, Kaplan B: Sirolimus with NEORAL versus mycophenolate mofetil with NEORAL is associated with decreased renal allograft survival. Am J Transplant 4: 2058-2066, 2004
47. Mendez R, Gonwa T, Yang HC, Weinstein S, Jensik S, Steinberg S, the Prograf Study Group: A prospective, randomized trial of tacrolimus in combination with sirolimus or mycophenolate mofetil in kidney transplantation: Results at 1 year. Transplantation 80: 303-309, 2005