Experience with everolimus

Transplantation Proceedings

Volumn 36, Issue 2 SUPPL., 2004, Pages S500-S503

  Augustine, J J ^a   Hricik, D E ^a,b  

^a CASE WESTERN RESERVE UNIVERSITY   (United States)

^b UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIMITOTIC AGENT; BASILIXIMAB; CALCINEURIN; CALCINEURIN INHIBITOR; CORTICOSTEROID; CYCLOSPORIN; CYCLOSPORIN A; EVEROLIMUS; IMMUNOPHILIN; IMMUNOSUPPRESSIVE AGENT; INITIATION FACTOR 4E; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PREDNISONE; RAPAMYCIN; S6 KINASE; TACROLIMUS; TARGET OF RAPAMYCIN KINASE;

APOPTOSIS; AREA UNDER THE CURVE; ARTICLE; B LYMPHOCYTE; CELL CYCLE PHASE; CELL PROLIFERATION; CLINICAL TRIAL; CYTOTOXIC T LYMPHOCYTE; DNA SYNTHESIS; DRUG BINDING; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; ENZYME BINDING; ENZYME INHIBITION; GRAFT REJECTION; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTRIGLYCERIDEMIA; IMMUNOSUPPRESSIVE TREATMENT; LIPID BLOOD LEVEL; LOW DRUG DOSE; LYMPHOPROLIFERATIVE DISEASE; NEPHROTOXICITY; NONHUMAN; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; PROTEIN SYNTHESIS; SIGNAL TRANSDUCTION; T LYMPHOCYTE ACTIVATION; VASCULAR DISEASE;

EID: 1642388492     PISSN: 00411345     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.transproceed.2004.01.059     Document Type: Article

References (36)

1. Neuhas P., Klupp J., Langrehr J.M. mTor inhibitors an overview. Liver Transpl. 7:2001;473.
2. Cole O.J., Shehata M., Rigg K.M. Effect of SDZ RAD on transplant arteriosclerosis in the rat aortic model. Transplant Proc. 30:1998;2200.
3. Salminen U.S., Alho H., Taskinen E., et al. Effects of rapamycin analogue SDZ RAD on obliterative lesions in a porcine heterotopic bronchial allograft model. Transplant Proc. 30:1998;2204.
4. Abraham R.T., Wiederrrecht G.J. Immunopharmacology of rapamycin. Annu Rev Immunol. 14:1996;483.
5. Schuler W., Sedrani R., Cottens S., et al. SDZ RAD, a new rapamycin derivative pharmacological properties in vitro and in vivo. Transplantation. 64:1997;36.
6. Schmidbauer G., Hancock W., Wasowska B., et al. Abrogation by rapamycin of accelerated rejection in sensitized rats by inhibition of alloantibody responses and selective suppression of intragraft mononuclear and endothelial cell activation, cytokine production, and cell adhesion. Transplantation. 57:1994;933.
7. Li Y., Zheng X., Li X., et al. Combined costimulation blockade plus rapamycin but not cyclosporine produces permanent engraftment. Transplantation. 66:1998;1387.
8. Wells A., Li X., Li Y., et al. Requirement for T-cell apoptosis in the induction of peripheral transplantation tolerance. Nat Med. 5:1999;1303.
9. Li Y., Li X., Zheng X., et al. Blocking both signal 1 and signal 2 of T-cell activation prevents apoptosis of alloreactive T cells and induction of peripheral allograft tolerance. Nat Med. 5:1999;1298.
10. Schuurman H., Cottens S., Fuchs S., et al. SDZ RAD, a new rapamycin derivative synergism with cyclosporine. Transplantation. 64:1997;32.
11. Hausen B., Boeke K., Berry G.J., et al. Suppression of acute rejection in allogeneic rat lung transplantation a study of the efficacy and pharmacokinetics of rapamycin derivative (SDZ RAD) used alone and in combination with a microemulsion formulation of cyclosporine. J Heart Lung Transplant. 18:1999;150.
12. Hausen B., Boeke K., Berry G., et al. Successful treatment of acute, ongoing rat lung allograft rejection with the novel immunosuppressant SDZ-RAD. Ann Thorac Surg. 69:2000;904.
13. Viklicky O., Zou H., Muller V., et al. SDZ-RAD prevents manifestation of chronic rejection in rat renal allografts. Transplantation. 69:2000;497.
14. Schuurman H., Ringers J., Schuler W., et al. Oral efficacy of the macrolide immunosuppressant SDZ RAD and of cyclosporine microemulsion in cynomolgus monkey kidney allotransplantation. Transplantation. 69:2000;737.
15. Hausen B., Gummert J., Berry G., et al. Prevention of acute allograft rejection in nonhuman primate lung transplant recipients induction with chimeric anti-interleukin-2 receptor monoclonal antibody improves the tolerability and potentiates the immunosuppressive activity of a regimen using low doses of both microemulsion cyclosporine and 40-O-(2-hydroxyethyl)- rapamycin. Transplantation. 69:2000;488.
16. Morris R.E., Huang X., Gregory C.R., et al. Studies in experimental models of chronic rejection use of rapamycin (sirolimus) and isoxazole derivatives (leflunomide and its analogue) for the suppression of graft vascular disease and obliterative bronchiolitis. Transplant Proc. 27:1995;2068.
17. Morris R.E., Cao W., Huang X., et al. Rapamycin (sirolimus) inhibits vascular smooth muscle DNA synthesis in vitro and suppresses narrowing in arterial allografts and in balloon-injured carotid areteries evidence that rapamycin antagonizes growth factor action on immune and nonimmune cells. Transplant Proc. 27:1995;430.
18. Salminen U.S., Alho H., Taskinen E., et al. Effects of rapamycin analogue SDZ RAD on obliterative lesions in a porcine heterotopic bronchial allograft model. Transplant Proc. 30:1998;2204.
19. Majewski M., Korecka M., Kossev P., et al. The immunosuppressive macrolide RAD inhibits growth of human Epstein-Barr virus-transformed B lymphocytes in vitro and in vivo a potential approach to prevention and treatment of posttransplant lymphoproliferative disorders. Proc Natl Acad Sci USA. 97:2000;4285.
20. Trepanier D.J., Gallant H., Legatt D.F., et al. Rapamycin distribution, pharmacokinetics and therapeutic range investigations: an update. Clin Biochem. 31:1998;345.
21. Stepkowski S.M., Tian L., Wang M.E., et al. Sirolimus in transplantation. Arch Immunol Ther Exp. 45:1997;383.
22. Kovarik J.M., Kalbag J., Figueiredo J., et al. Differential influence of two cyclosporine formulations on everolimus pharmacokinetics a clinically relevant pharmacokinetic interaction. J Clin Pharmacol. 42:2002;95.
23. Kovarik J.M., Kahan B.D., Kaplan B., et al. Longitudinal assessment of everolimus in de novo renal transplant recipients over the first post-transplant year pharmacokinetics, exposure-response relationships, and influence on cyclosporine. Clin Pharmacol Ther. 69:2000;48.
24. Kovarik J.M., Kaplan B., Tedesco-Silva H., et al. Exposure-response relationships for everolimus in de novo kidney transplantation defining a therapeutic range. Transplantation. 73:2002;920.
25. Kovarik J.M., Hsu C.H., McMahon L., et al. Population pharmacokinetics of everolimus in de novo renal transplant patients impact of ethnicity and comedications. Clin Pharmacol Ther. 70:2001;247.
26. Kovarik J.M., Hartmann S., Figueiredo J., et al. Effect of food on everolimus absorption quantification in healthy subjects and a confirmatory screening in patients with renal transplants. Pharmacotherapy. 22:2002;154.
27. Kovarik J.M., Sabia H.D., Figueiredo J., et al. Influence of hepatic impairment on everolimus pharmacokinetics implications for dose adjustment. Clin Pharmacol Ther. 70:2001;425.
28. Neumayer H.H., Paradis K., Korn A., et al. Entry-into-human study with the novel immunosuppressant SDZ RAD in stable renal transplant recipients. Br J Clin Pharmacol. 48:1999;694.
29. Kahan B.D., Wong R.L., Carter C., et al. A phase I study of a 4-week course of SDZ-RAD (RAD) in quiescent cyclosporine-prednisone-treated renal transplant recipients. Transplantation. 68:1999;1100.
30. Kahan B.D., Kaplan B., Lorber M.I., et al. RAD in de novo renal transplantation comparison of three doses on the incidence and severity of acute rejection. Transplantation. 71:2001;1400.
31. Vitko S., Margreiter R., Weimar W., et al. International, double-blind, parallel group study of the safety and efficacy of Certican (RAD) versus mycophenolate mofetil (MMF) in combination with Neoral and steroids. Am J Transplant. 1:(suppl 1):2001;474.
32. Kaplan B., Tedesco-Silva H., Mendez R., et al. North/South American, double-blind, parallel group study of the safety and efficacy of Certican (RAD) versus mycophenolate mofetil (MMF) in combination with Neoral and coricosteroids. Am J Transplant. 1:(suppl 1):2001;475.
33. Kahan B.D. Efficacy of sirolimus compared with azathioprine for reduction of acute renal allograft rejection a randomized multicentre study. Lancet. 356:2000;194.
34. Curtis J., Nashan B., Ponticelli C., et al. One year results of a multicenter, open-label trial on safety and efficacy of Certican (RAD) used in combination with Simulect, corticosteroids, and full or reduced dose Neoral in renal transplantation. Am J Transplant. 1:(suppl 1):2001;474.
35. Eisen H.J., Tuzcu E.M., Dorent R., et al. Everolimus for the preventioin of allograft rejection and vasculopathy in cardiac transplant recipients. N Engl J Med. 349:2003;847.
36. Mancini D., Pinney S., Burkhoff D., et al. Use of rapamycin slows progression of cardiac transplantation vasculopathy. Circulation. 108:2003;48.