Safety and efficacy of intensified versus standard dosing regimens of enteric-coated mycophenolate sodium in de Novo renal transplant patients

Transplantation

Volumn 91, Issue 7, 2011, Pages 779-785

  Sommerer, Claudia ^a,f   Glander, Petra ^b   Arns, Wolfgang ^c   Ariatabar, Tofan ^c   Kramer, Stefan ^d   Vogel, Eva Maria ^d   Shipkova, Maria ^e   Fischer, Wolfgang ^d   Liefeldt, Lutz ^b   Hackenberg, Ruth ^c   Schmidt, Jan ^a   Zeier, Martin ^c   Budde, Klemens ^b  

^a UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

^b CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^c Medical Clinic Köln Merheim   (Germany)

^d NOVARTIS PHARMA GMBH   (Germany)

^e Department of Clinical Chemistry   (Germany)

^f UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

Acute rejection; Enteric coated mycophenolate sodium; Renal transplantation

Indexed keywords

BASILIXIMAB; CYCLOSPORIN A; MYCOPHENOLIC ACID; STEROID;

ABDOMINAL PAIN; ACUTE GRAFT REJECTION; ADULT; ANEMIA; ARTICLE; BK NEPHROPATHY; BK VIRUS INFECTION; COHORT ANALYSIS; CONSTIPATION; CONTROLLED STUDY; CYTOMEGALOVIRUS INFECTION; DIARRHEA; DOSAGE SCHEDULE COMPARISON; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; ENTERIC COATED TABLET; EXPLORATORY RESEARCH; FEMALE; FLATULENCE; GASTROINTESTINAL DISEASE; GASTROINTESTINAL SYMPTOM RATING SCALE; GERMANY; GRAFT FAILURE; GRAFT RECIPIENT; GRAFT REJECTION; HEALING IMPAIRMENT; HEMATOLOGIC DISEASE; HUMAN; HUMAN TISSUE; INFECTION; KIDNEY BIOPSY; KIDNEY DISEASE; KIDNEY FUNCTION; KIDNEY TRANSPLANTATION; LEUKOPENIA; LYMPHOCELE; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; NAUSEA; PNEUMOCYSTIS PNEUMONIA; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RESPIRATORY TRACT INFECTION; THROMBOCYTOPENIA; TREATMENT FAILURE; URINARY TRACT INFECTION; VIREMIA; VIRUS INFECTION; VOMITING; WOUND INFECTION;

ADULT; AGED; FEMALE; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; PROSPECTIVE STUDIES; TABLETS, ENTERIC-COATED;

EID: 79954682704     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/TP.0b013e31820d3b9b     Document Type: Article

References (27)

1. Kuypers DR, Le Meur Y, Cantarovich M, et al. Consensus report on therapeutic drug monitoring of mycophenolic acid on solid organ transplantation. Clin J Am Soc Nephrol 2010; 5: 341.
2. van Gelder T, Le Meur Y, Shaw LM, et al. Therapeutic drug monitoring of mycophenolate mofetil in transplantation. Ther Drug Monit 2006; 28: 145.
3. Knight SR, Morris PJ. Does the evidence support the use of mycophenolate mofetil therapeutic drug monitoring in clinical practice? A systematic review. Transplantation 2008; 85: 1675.
4. Jeong H, Kaplan B. Therapeutic monitoring of mycophenolate mofetil. Clin J Am Soc Nephrol 2007; 2: 184.
5. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of mycophenolate in solid organ transplant recipients. Clin Pharmacokinet 2007; 46: 13.
6. Le Meur Y, Büchler M, Thierry A, et al. Individualized mycophenolate mofetil dosing based on drug exposure significantly improves patient outcomes after renal transplantation. Am J Transplant 2007; 7: 2496.
7. van Gelder T, Silva HT, de Fijter JW, et al. Comparing mycophenolate mofetil regimens for de novo renal transplant recipients: The fixeddose concentration-controlled trial. Transplantation 2008; 86: 1043.
8. Kuypers DR, Vanrenterghem Y, Squifflet JP, et al. Twelve-month evaluation of the clinical pharmacokinetics of total and free mycophenolic acid and its glucuronide metabolites in renal allograft recipients on low dose tacrolimus in combination with mycophenolate mofetil. Ther Drug Monit 2003; 25: 609.
9. 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.
10. Kiberd BA, Lawen J, Fraser AD, et al. Early adequate mycophenolic acid exposure is associated with less rejection in kidney transplantation. Am J Transplant 2004; 4: 1079.
11. Nankivell BJ, Borrows RJ, Fung CL, et al. The natural history of chronic allograft nephropathy. N Engl J Med 2003; 349: 2326.
12. Glander P, Sommerer C, Arns W, et al. Pharmacokinetics and pharmacodynamics of intensified versus standard dosing of mycophenolate sodium in renal transplant patients. Clin J Am Soc Nephrol 2010; 5: 503.
13. Gourishankar A, Houde I, Keown PA, et al. The CLEAR Study:A5-day, 3-g loading dose of mycophenolate mofetil versus standard 2-g dosing in renal transplantation. Clin J Am Soc Nephrol 2010; 5: 1282.
14. Sommerer C, Müller-Krebs S, Schaier M, et al. Pharmacokinetic and pharmacodynamic analysis of enteric-coated mycophenolate sodium: Limited sampling strategies and clinical outcome in renal transplant patients. Br J Clin Pharm 2010; 69: 346.
15. Gaston RS, Kaplan B, Shah T, et al. Fixed- or controlled-dose mycophenolate mofetil with standard- or reduced-dose calcineurin inhibitors: The Opticept trial. Am J Transplant 2009; 9: 1607.
16. De Winter BC, van Gelder T, Mathot RA, et al. Limited sampling strategies drawn within 3 hours postdose poorly predict mycophenolic acid area-under-the-curve after enteric-coated mycophenolate sodium. Ther Drug Monit 2009; 3: 585.
17. Tedesco-Silva H, Cibrik D, Johnston T, et al. Everolimus plus reducedexposure CsA versus mycophenolic acid plus standard-exposure CsA in renal-transplant recipients. Am J Transplant 2010; 10: 1401.
18. Vincenti F, Charpentier B, Vanrenterghem Y, et al. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study).AmJ Transplant 2010; 10: 535.
19. Silva HT Jr, Yang HC, Abouljoud M, et al. One-year results with extended release tacrolimus/MMF, tacrolimus/MMF and cyclosporine/MMF in de novo kidney transplant recipients. Am J Transplant 2007; 7: 595.
20. Ekberg H, Tedesco-Silva H, Demirbas A, et al. Reduced exposure to calcineurin inhibitors in renal transplantation. N Engl J Med 2007; 357: 2564.
21. Kamar N, Mariat C, Albano L, et al. Improvement in renal function following conversion from low-dose mycophenolate acid to higher-dose enteric-coated mycophenolate sodium (EC-MPS) with concomitant tacrolimus reduction in maintenance kidney transplant recipients. Transpl Int 2009; 22(suppl 2): 78(Abstract O-295).
22. Halloran PF. T cell-mediated rejection of kidney transplants: A personal viewpoint. Am J Transplant 2010; 10: 1126.
23. Grinyó JM, Ekberg H, Mamelok RD, et al. The pharmacokinetics of mycophenolate mofetil in renal transplant recipients receiving standard-dose or low-dose cyclosporine, low-dose tacrolimus or lowdose sirolimus: The Symphony pharmacokinetic substudy. Nephrol Dial Transplant 2009; 24: 2269.
24. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31.
25. Racusen LC, Halloran PF, Solez K. Banff 2003 meeting report: New diagnostic insights and standards. Am J Transplant 2004; 4: 1562.
26. Svedlund J, Sjodin I, Dotevall G. GSRS -A clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci 1988; 33: 129.
27. Kulich KR, Malfertheiner P, Madisch A, et al. Psychometric validation of the German translation of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in patients with reflux disease. Health Qual Life Outcomes 2003; 1: 62.