The evolving experience using everolimus in clinical transplantation

Transplantation Proceedings

Volumn 36, Issue 2 SUPPL., 2004, Pages S495-S499

  Formica Jr , R N ^a   Lorber, K M ^a   Friedman, A L ^a   Bia, M J ^a   Lakkis, F ^a   Smith, J D ^a   Lorber, M I ^a  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CALCINEURIN INHIBITOR; CYCLOSPORIN A; CYTOCHROME P450; EVEROLIMUS; IMMUNOSUPPRESSIVE AGENT; ISOENZYME; RAPAMYCIN; TACROLIMUS; TARGET OF RAPAMYCIN INHIBITOR; UNCLASSIFIED DRUG;

CLINICAL PROTOCOL; CLINICAL TRIAL; DISEASE EXACERBATION; DRUG ACTIVITY; DRUG BIOAVAILABILITY; DRUG EFFECT; DRUG MECHANISM; DRUG POTENCY; DRUG PROTEIN BINDING; DRUG TRANSFORMATION; ENZYME INHIBITION; EXPERIENCE; FIBROBLAST; GRAFT REJECTION; HEART TRANSPLANTATION; HUMAN; HYPERLIPIDEMIA; KIDNEY TRANSPLANTATION; LYMPHOCYTE PROLIFERATION; NEPHROTOXICITY; NONHUMAN; PRIORITY JOURNAL; REVIEW; SIDE EFFECT; SMOOTH MUSCLE FIBER; ULTRASOUND;

STREPTOMYCES HYGROSCOPICUS;

EID: 1642378790     PISSN: 00411345     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.transproceed.2004.01.015     Document Type: Article

References (46)

1. Dumont F.J. Everolimus. Novartis. Curr Opin Invest Drugs. 9:2001;1220.
2. Schuurman H.-J., Cottens S., Fuchs S., et al. SDZ RAD, a new rapamycin derivative synergism with cyclosporine. Transplantation. 64:1997;32.
3. Schuurman H.-J., 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.
4. 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.
5. Hausen B., Boeke K., Berry G.J., et al. Coadministration of neoral and the novel rapamycin analog, SDZ RAD, to rat lung allograft recipients potentiation of immunosuppressive efficacy and improvement of tolerability of staggered versus simultaneous treatment. Transplantation. 67:1999;956.
6. Hausen B., Ikonen T., Briffa N., et al. Combined immunosuppression with cyclosporine (neoral) and SDZ RAD in non-human primate lung transplantation systematic pharmacokinetic-based trials to improve efficacy and tolerability. Transplantation. 69:2000;76.
7. Viklicky O., Zou H., Muller V., et al. SDZ-RAD prevents manifestation of chronic rejection in rat renal allografts. Transplantation. 69:2000;497.
8. Niklova Z., Hof A., Baumlin Y., et al. The peripheral lymphocyte count predicts graft survival in DA to Lewis heterotopic heart transplantation treated with FTY720 and SDZ RAD. Transplant Immunol. 8:2000;115.
9. 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.
10. Eisen H.J., Tuzcu E.M., Dorent R., et al. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N Engl J Med. 349:2003;847.
11. Majewski M., Korecka M., Joergensen J., et al. Immunosuppressive TOR kinase inhibitor everolimus (RAD) suppresses growth of cells derived from posttransplant lymphoproliferative disorder at allograft-protecting doses. Transplantation. 75:2003;1710.
12. Kahan B.D., Wong R.L., Carter C., et al. A phase I study of a 4-week course of SDZ-RAD (RAD) quiescent cyclosporine-prednisone-treated renal transplant recipients. Transplantation. 68:1999;1100.
13. 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.
14. Vitko S., Margreiter R., Weimar W., et al. Am J Transplantation. 1: (Suppl 1):2001;1337.
15. Kaplan B., Tedesco S.H., Mendez R., et al. Am J Transplant. 1:(Suppl 1):2001;1339.
16. Segal S.N. Rapamune (RAPA, rapamycin, sirolimus) mechanism of action immunosuppressive effect results from blockade of signal transduction and inhibition of cell cycle progression. Clin Biochem. 31:1998;335.
17. Sakata A., Kuwahara K., Ohmura T., et al. Involvement of a rapamycin-sensitive pathway in CD40-mediated activation of murine B cells in vitro. Immunol Lett. 68:1999;301.
18. Tereda N., Lucas J.J., Szepesi A., et al. Rapamycin blocks cell cycle progression of activated T cells prior to events characteristic of the middle to late G1 phase of the cycle. J Cell Physiol. 154:1993;7.
19. Flanagan W.M., Crabtree G.R. Rapamycin inhibits p34cdc2 expression and arrests T lymphocyte proliferation at the G1/S transition. Ann NY Acad Sci. 696:1993;31.
20. Vilella-Bach M., Nuzzi P., Fang Y., et al. The FKBP12-rapamycin-binding domain is required for FKBP12-rapamycin-associated protein kinase activity and G1 progression. J Biol Chem. 274:1999;4266.
21. Schuurman H.J., Cottens S., Fuchs S., et al. SDZ RAD, a new rapamycin derivative synergism with cyclosporine. Transplantation. 64:1997;32.
22. Kirchner G.I., Winkler M., Mueller L., et al. Pharmacokinetics of SDZ RAD and cyclosporin including their metabolites in seven kidney graft patients after the first dose of SDZ RAD. Br J Clin Pharmacol. 50:2000;449.
23. Kahan B.D., Wong R.L., Carter C., et al. A phase I study of a 4-week course of SDZ-RAD (RAD) quiescent cyclosporine-prednisone-treated renal transplant recipients. Transplantation. 68:1999;1100.
24. 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.
25. 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. 69:2001;48.
26. 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.
27. Kovarik J.M., Kaplan B., Silva H.T., et al. Pharmacokinetics of an everolimus-cyclosporine immunosuppressive regimen over the first 6 months after kidney transplantation. Am J Transplant. 3:2003;606.
28. Kovarik J.M., Sabia H., Rouilly M., et al. Am J Transplant. 1:(Suppl 1):2001;989.
29. 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 Ther. 42:2002;95.
30. Kovarik J.M., Hartmann S., Figueiredo J., et al. Rifampin significantly increases the clearance of everolimus implications for co-administration. Am J Transplant. 1:(Suppl 1):2001;643.
31. Sedrani R., Cottens S., Kallen J., et al. Chemical modification of rapamycin the discovery of SDZ RAD. Transplant Proc. 30:1998;2192.
32. Serkova N., Jacobson W., Niemann C.U., et al. Sirolimus, but not the structurally related RAD (everolimus), enhances the negative effects of cyclosporine on mitochondrial metabolism in the rat brain. Br J Pharmacol. 133:2001;875.
33. Kahan B.D., for the Rapamune U.S. Study Group. Efficacy of sirolimus compared with azathioprine for reduction of acute renal allograft rejection a randomised multicentre study. The Rapamune US Study Group. Lancet. 356:2000;194.
34. MacDonald A.S., for the Rapamune U.S. Study Group. A worldwide, phase III, randomized, controlled, safety and efficacy study of a sirolimus/ cyclosporine regimen for prevention of acute rejection in recipients of primary mismatched renal allografts. Transplantation. 71:2001;271.
35. Curtis J., Nashan B., Ponticelli C., et al. One-year results of a multicenter, open label trial on safety and efficacy of certican used in combination with simulect, corticosteroids, and full or reduced dose Neoral in renal transplantation. Am J Transplantation. 1:(Suppl 1):2001;1335.
36. Tedesco H., Ambuhl P., Lorber M.I., et al. Improved renal function following cyclosporine dose reduction in maintenance renal transplant recipients taking everolimus. Am J Transplantation. 2:(Suppl 3):2002;274.
37. Kovarik J.M., Kaplan B., Tedesco S.H., et al. Exposure-response relationships for everolimus in de novo kidney transplantation defining a therapeutic range. Transplantation. 73:2002;920.
38. Lorber M.I., Ponticelli C., Mayer H.W., et al. Everolimus dose recommendations based on efficacy modeling and simulations of therapeutic drug monitoring. Am J Transplantation. 2:(Suppl 3):2002;186.
39. Morice M.C., Serruys P.W., Sousa J.E., et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 346:2002;1773.
40. Fab A., John M., Acampado E., et al. Oral everolimus inhibits in-stent neointimal growth. Circulation. 106:2002;2379.
41. Luan F., Hojo M., Maluccio K., et al. Rapamycin upregulates the expression of tumor invasion suppressor E-cadhedrin. Am J Transplant. 2:2002;324.
42. Geissler EK, Koel G, Andrassy J, et al: Immunosuppressive doses of rapamycin protect allografts from rejection while simultaneously causing regression of established tumors in mice. Am J Transplant 2:383, 2002
43. 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.
44. Flechner S.M., Goldfarb D., Modlin C., et al. Kidney transplantation without calcineurin inhibitor drugs a prospective, randomized trial of sirolimus versus cyclosporine. Transplantation. 74:2002;1070.
45. Saunders R.N., Bicknell G.R., Nicholson M.L. The impact of cyclosporine dose reduction with or without the addition of rapamycin on functional, molecular and histological markers of chronic allograft nephropathy. Transplantation. 75:2003;772.
46. Lutz J., Zou H., Liu S., et al. Apoptosis and treatment of chronic allograft nephropathy with everolimus. Transplantation. 76:2003;508.