Adverse drug reaction driven immunosuppressive drug manipulations: A single-center comparison of enteric-coated mycophenolate sodium vs. mycophenolate mofetil

Clinical Transplantation

Volumn 22, Issue 5, 2008, Pages 555-561

  Hardinger, Karen L ^a   Hebbar, Sudarshan ^b   Bloomer, Terry ^b   Murillo, Daniel ^c  

^a UNIVERSITY OF MISSOURI KANSAS CITY   (United States)

^b UNIVERSITY OF KANSAS HOSPITAL   (United States)

^c Research Medical Center Brookside Campus   (United States)

Author keywords

Adverse events; Gastrointestinal; Mycophenolic acid

Indexed keywords

ACICLOVIR; AZATHIOPRINE; CLOTRIMAZOLE; COTRIMOXAZOLE; CREATININE; DAPSONE; HISTAMINE H2 RECEPTOR ANTAGONIST; METHYLPREDNISOLONE; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PROTON PUMP INHIBITOR; RAPAMYCIN; TACROLIMUS; THYMOCYTE ANTIBODY; VALGANCICLOVIR;

ACUTE GRAFT REJECTION; ADULT; ARTHRALGIA; ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CYTOMEGALOVIRUS INFECTION; DRUG DOSE REDUCTION; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; ENTERIC COATED TABLET; FEMALE; GASTROINTESTINAL DISEASE; GRAFT SURVIVAL; HERPES SIMPLEX; HOSPITAL ADMISSION; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; INFECTION; KIDNEY FAILURE; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; LEUKOPENIA; LIVER TOXICITY; LOG RANK TEST; LYMPHOPROLIFERATIVE DISEASE; MAJOR CLINICAL STUDY; MALE; MYCOSIS; PANCREAS INSUFFICIENCY; PANCREAS TRANSPLANTATION; PNEUMOCYSTOSIS; PRIORITY JOURNAL; RETROSPECTIVE STUDY; STATISTICAL SIGNIFICANCE; SURVIVAL RATE; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT;

ADULT; COHORT STUDIES; DRUG COMPOUNDING; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; PANCREAS TRANSPLANTATION; RETROSPECTIVE STUDIES; TABLETS, ENTERIC-COATED;

EID: 52649135035     PISSN: 09020063     EISSN: 13990012     Source Type: Journal    
DOI: 10.1111/j.1399-0012.2008.00820.x     Document Type: Article

References (19)

1. Halloran P, Mathew T, Tomlanovich S et al. Mycophenolate mofetil in renal allograft recipients: A pooled efficacy analysis of three randomized, double-blind, clinical studies in prevention of rejection. The International Mycophenolate Mofetil Renal Transplant Study Groups. Transplantation 1997: 63: 39.
2. Mathew TH. A blinded, long-term, randomized multicenter study of mycophenolate mofetil in cadaveric renal transplantation: Results at three years. Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. Transplantation 1998: 65: 1450.
3. Miller J, Mendez R, Pirsch JD, Jensik SC. Safety and efficacy of tacrolimus in combination with mycophenolate mofetil (MMF) in cadaveric renal transplant recipients. FK506/MMF Dose-Ranging Kidney Transplant Study Group. Transplantation 2000: 69: 875.
4. Knoll GA, Mac Donald I, Khan A, Van Walraven C. Mycophenolate mofetil dose reduction and the risk of acute rejection after renal transplantation. J Am Soc Nephrol 2003: 14: 2381.
5. Hardinger KL, Brennan DC, Lowell J, Schnitzler MA. Long-term outcome of gastrointestinal complications in renal transplant patients treated with mycophenolate mofetil. Transpl Int 2004: 17: 609.
6. Bunnapradist S, Lentine KL, Burroughs TE et al. Mycophenolate mofetil dose reductions and discontinuations after gastrointestinal complications are associated with renal transplant graft failure. Transplantation 2006: 82: 102.
7. Pelletier RP, Akin B, Henry ML et al. The impact of mycophenolate mofetil dosing patterns on clinical outcome after renal transplantation. Clin Transplant 2003: 17: 200.
8. Salvadori M, Holzer H, de Mattos A et al. Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients. Am J Transplant 2004: 4: 231.
9. Budde K, Curtis J, Knoll G et al. Enteric-coated mycophenolate sodium can be safely administered in maintenance renal transplant patients: results from a 1-year study. Am J Transplant 2004: 4: 237.
10. Massari P, Duro-Garcia V, Giron F et al. Safety assessment of the conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in stable renal transplant recipients. Transplant Proc 2005: 37: 916.
11. Chan L, Mulganonkar S, Waler R et al. Patient reported gastrointestinal symptom burden and health related quality of life following conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium. Transplantation 2006: 81: 1290.
12. Pelletier RP, Soule J, Henry ML, Rajab A, Ferguson RM. Clinical outcome of renal transplant recipients treated with enteric-coated mycophenolic acid vs. mycophenolate as a switch agent using a primary steroid-free rapamune and microemulsion cyclosporine protocol. Clin Tranplant 2007: 21: 532.
13. Van Gelder T, Hilbrands LB, Vanrenterghem Y et al. A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation 1999: 68: 261.
14. Kuypers DR, Claes K, Evenepoel P et al. Clinical efficacy and toxicity profile of tacrolimus and mycophenolic acid in relation to combined long-term pharmacokinetics in de novo renal allograft recipients. Clin Pharmacol Ther 2004: 75: 434.
15. Mourad M, Malaise J, Chaib Eddour D et al. Pharmacokinetics basis for the efficient and safe use of low-dose mycophenolate mofetil in combination with tacrolimus in kidney transplantation. Clin Chem 2001: 47: 1241.
16. Bloom R, Naraghi R, Cibrik D et al. Opticept trial: Interim results of 6-month efficacy and safety of monitored mycophenolate mofetil (MMF) in combination with CNI in renal transplantation. 2006 World Transplant Congress. Boston, MA. July 2006. Am J Transplant 2006: 6: 2904 (Abstract).
17. Johnston A, He X, Holt DW. Bioequivalence of enteric-coated mycophenolate sodium and mycophenolate mofetil: A meta-analysis of three studies in stable renal transplant recipients. Transplantation 2006: 82: 1413.
18. Budde K, Tedesco-Silva H, Pestana JM et al. Enteric coated mycophenolate sodium provides higher mycophenolic acid predose levels compared with mycophenolate mofetil: Implications for therapeutic drug monitoring. Ther Drug Monit 2007: 29: 381.
19. Cattaneo D, Cortinovis M, Baldelli S et al. Pharmacokinetics of mycophenolate sodium and comparison with the mofetil formulation in stable kidney transplant recipients. Clin J Am Soc Nephrol 2007: 2: 1147.