Bioequivalence of enteric-coated mycophenolate sodium and mycophenolate mofetil: A meta-analysis of three studies in stable renal transplant recipients

Transplantation

Volumn 82, Issue 11, 2006, Pages 1413-1418

  Johnston, Atholl ^a   He, Xiang ^a   Holt, David W ^b  

^a QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^b ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

Author keywords

Bioequivalence; Meta analysis; Mycophenolate

Indexed keywords

ACYL MYCOPHENOLIC ACID GLUCURONIDE; ANTIVIRUS AGENT; CYCLOSPORIN A; DRUG METABOLITE; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; MYCOPHENOLIC ACID BETA D GLUCURONIDE; SODIUM; STEROID;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONCENTRATION RESPONSE; CONFIDENCE INTERVAL; DATA ANALYSIS; DRUG BLOOD LEVEL; DRUG COATING; DRUG EXPOSURE; DRUG FORMULATION; GASTROINTESTINAL SYMPTOM; GRAFT RECIPIENT; HUMAN; KIDNEY GRAFT; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; META ANALYSIS; METABOLITE; PRIORITY JOURNAL; SINGLE DRUG DOSE; SYSTEMATIC REVIEW;

GLUCURONIDES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MYCOPHENOLIC ACID; TABLETS, ENTERIC-COATED; THERAPEUTIC EQUIVALENCY;

EID: 33845719435     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.tp.0000242137.68863.89     Document Type: Article

References (39)

1. Ciancio G, Miller J, Gonwa TA. Review of major clinical trials with mycophenolate mofetil in renal transplantation. Transplantation 2005; 80(2 Suppl): S191.
2. Allison AC, Eugui EM. Mechanisms of action of mycophenolate mofetil in preventing acute and chronic allograft rejection. Transplantation 2005; 80(2 Suppl): S181.
3. Bullingham R, Monroe S, Nicholls A, Hale M. Pharmacokinetics and bioavailability of mycophenolate mofetil in healthy subjects after single-dose oral and intravenous administration. J Clin Pharmacol 1996; 36(4): 315.
4. Hale MD, Nicholls AJ, Bullingham RE, et al. The pharmacokinetic- pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther 1998; 64(6): 672.
5. van Gelder T, Shaw LM. The rationale for and limitations of therapeutic drug monitoring for mycophenolate mofetil in transplantation. Transplantation 2005; 80(2 Suppl): S244.
6. 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(2): 261.
7. Shaw LM, Nawrocki A, Korecka M, et al. Using established immunosuppressant therapy effectively: lessons from the measurement of mycophenolic acid plasma concentrations. TherDrug Monit 2004; 26(4): 347.
8. Shaw LM, Korecka M, Venkataramanan R, et al. Mycophenolic acid pharmacodynamics and pharmacokinetics provide a basis for rational monitoring strategies. Am J Transplant 2003; 3(5): 534.
9. Shaw LM, Holt DW, Oellerich M, et al. Current issues in therapeutic drug monitoring of mycophenolic acid: report of a roundtable discussion. Ther Drug Monit 2001; 23(4): 305.
10. Behrend M. A review of clinical experience with the novel immunosuppressive drug mycophenolate mofetil in renal transplantation. Clin Nephrol 1996; 45(5): 336.
11. 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(3): 200.
12. Budde K, Glander P, Diekmann F, et al. Review of the immunosuppressant enteric-coated mycophenolate sodium. Expert Opin Pharmacother 2004; 5(6): 1333.
13. Tedesco-Silva H, Bastien MC, Choi L, et al. Mycophenolic acid metabolite profile in renal transplant patients receiving enteric-coated mycophenolate sodium or mycophenolate mofetil. Transplant Proc 2005; 37(2): 852.
14. 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(2): 231.
15. Budde K, Curtis J, Knoll G, et al. Enteric-coated mycophenolate sodium can be safely administered in maintenance renal transplant patients: results of a 1-year study. Am J Transplant 2004; 4(2): 237.
16. Chan L, Mulgaonkar S, Walker 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(9): 1290.
17. Salvadori M, Bock A, Chapman J, et al. Impact of mycophenolate mofetil dose posttransplantation on 12-month renal function: analysis of the MOST database. Transplant Proc 2005; 37(6): 2464.
18. Arns W, Breuer S, Choudhury S, et al. Enteric-coated mycophenolate sodium delivers bioequivalent MPA exposure compared with mycophenolate mofetil. Clin Transplant 2005; 19(2): 199.
19. CDER, FDA. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products: General Considerations. Available at: www.fda.gov/cder/guidance/5356fnl.pdf. Accessed June 16, 2006.
20. CDER, FDA. Analytical Procedures and Methods Validation. Available at: www.fda.gov/cder/guidance/2396dft.pdf. Accessed January 16, 2006.
21. ICH. Topic 2QB: Validation of analytical procedures: Methodology. Available at: www.emea.eu.int/pdfs/human/ich/028195en.pdf. Accessed January 16, 2006.
22. CPMP. Note for guidance on the investigation of bioavailability and bioequivalence. Available at: www.emea.eu.int/pdfs/human/ewp/140198en.pdf. Accessed June 16, 2006.
23. Butler A, Rothery P, Roy D. Minitab macros for resampling methods. Teach Statistics 2003; 25(1): 22.
24. Butler A. Minitab Macros for Resampling Methods. Available at: www.ceh.ac.uk/products/software/minitab/download.asp. Accessed January 16, 2006.
25. Efron B, Tibshirani J. An introduction to the Bootstrap. London, UK: Chapman and Hall; 1993.
26. Manly BFJ. Randomization, bootstrap and Monte Carlo methods in biology. 2nd ed. London, UK: Chapman and Hall; 1997.
27. Tierce JC, Porterfield-Baxa J, Petrilla AA, et al. Impact of mycophenolate mofetil (MMF)-related gastrointestinal complications and MMF dose alterations on transplant outcomes and healthcare costs in renal transplant recipients. Clin Transplant 2005; 19(6): 779.
28. Pescovitz MD, Conti D, Dunn J, et al. Intravenous mycophenolate mofetil: safety, tolerability, and pharmacokinetics. Clin Transplant 2000; 14(3): 179.
29. Johnston A, Belitsky P, Frei U, et al. Potential clinical implications of substitution of generic cyclosporine formulations for cyclosporine microemulsion (Neoral) in transplant recipients. Eur J Clin Pharmacol 2004; 60(6): 389.
30. Kaplan B, Meier-Kriesche HU, Minnick P, et al. Randomized calcineurin inhibitor cross over study to measure the pharmacokinetics of co-administered enteric-coated mycophenolate sodium. Clin Transplant 2005; 19(4): 551.
31. Oellerich M, Shipkova M, Schutz E, et al. Pharmacokinetic and metabolic investigations of mycophenolic acid in pediatric patients after renal transplantation: implications for therapeutic drug monitoring. German Study Group on Mycophenolate Mofetil Therapy in Pediatric Renal Transplant Recipients. Ther Drug Monit 2000; 22(1): 20.
32. Health Canada. Conduct and Analysis of Bioavailability and Bioequivalence Studies. Available at: www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/ prodpharma/bio-a_e.pdf. Accessed July 14, 2006.
33. Johnston A, Keown PA, Holt DW. Simple bioequivalence criteria: are they relevant to critical dose drugs? Experience gained from cyclosporine. Ther Drug Monit 1997; 19(4): 375.
34. Pollard S, Nashan B, Johnston A, et al. A pharmacokinetic and clinical review of the potential clinical impact of using different formulations of cyclosporin A. Berlin, Germany, November 19, 2001. Clin Ther 2003; 25(6): 1654.
35. Cattaneo D, Perico N, Remuzzi G. Generic cyclosporine formulations: more open questions than answers. Transpl Int 2005; 18(4): 371.
36. Hibberd AD, Trevillian PR, Roger SD, et al. Assessment of the bioequivalence of a generic cyclosporine A by a randomized controlled trial in stable renal recipients. Transplantation 2006; 81(5): 711.
37. Koehler J, Kuehnel T, Kees F, et al. Comparison of bioavailability and metabolism with two commercial formulations of cyclosporine a in rats. Drug Metab Dispos 2002; 30(6): 658.
38. Kees F, Mair G, Dittmar M, Bucher M. Cicloral versus neoral: a bioequivalence study in healthy volunteers on the influence of a fat-rich meal on the bioavailability of cicloral. Transplant Proc 2004; 36(10): 3234.
39. Taber DJ, Baillie GM, Ashcraft EE, et al. Does bioequivalence between modified cyclosporine formulations translate into equal outcomes? Transplantation 2005; 80(11): 1633.