Optimal everolimus concentration is associated with risk reduction for acute rejection in de Novo renal transplant recipients

Transplantation

Volumn 90, Issue 1, 2010, Pages 31-37

  Chan, Laurence ^a   Hartmann, Erica ^b   Cibrik, Diane ^c   Cooper, Matthew ^d   Shaw, Leslie M ^e  

^a UNIVERSITY OF COLORADO   (United States)

^b WAKE FOREST UNIVERSITY   (United States)

^c UNIVERSITY OF MICHIGAN   (United States)

^d UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Everolimus; Immunosuppression; Outcomes; Renal transplantation; Tacrolimus.

Indexed keywords

BASILIXIMAB; CORTICOSTEROID; EVEROLIMUS; TACROLIMUS;

ACUTE GRAFT REJECTION; ADULT; ANEMIA; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; CORTICOSTEROID THERAPY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; EDEMA; FEMALE; GLOMERULUS FILTRATION RATE; GRAFT RECIPIENT; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY BIOPSY; KIDNEY FUNCTION; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; OUTCOME ASSESSMENT; PERIPHERAL EDEMA; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION;

ADULT; BIOPSY; CADAVER; DRUG THERAPY, COMBINATION; FEMALE; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY FAILURE, CHRONIC; KIDNEY TRANSPLANTATION; LIVING DONORS; MALE; MIDDLE AGED; SIROLIMUS; TACROLIMUS; TISSUE DONORS;

EID: 77954624204     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/TP.0b013e3181de1d67     Document Type: Article

References (21)

1. Vítko S, Margreiter R, Weimar W, et al. Everolimus (Certican) 12-month safety and efficacy versus mycophenolate mofetil in de novo renal transplant recipients. Transplantation 2004; 78: 1532.
2. Vítko S, Margreiter R, Weimar W, et al. Three-year efficacy and safety results from a study of everolimus versus mycophenolate mofetil in de novo renal transplant patients. Am J Transplant 2005; 5: 2521.
3. Lorber MI, Mulgaonkar S, Butt KM, et al. Everolimus versus myco-phenolate mofetil in the prevention of rejection in de novo renal transplant recipients: A 3-year randomized, multicenter, phase III study. Transplantation 2005; 80: 244.
4. Lorber MI, Ponticelli C, Whelchel J, et al. Therapeutic drug monitoring for everolimus in kidney transplantation using 12-month exposure, efficacy, and safety data. Clin Transplant 2005; 19: 145.
5. Nashan B, Curtis J, Ponticelli C, et al. Everolimus and reduced-exposure cyclosporine in de novo renal-transplant recipients: A three-year phase II, randomized, multicenter, open-label study. Transplantation 2004; 78: 1332.
6. Vítko S, Tedesco H, Eris J, et al. Everolimus with optimized cyclosporine dosing in renal transplant recipients: 6-Month safety and efficacy results of two randomized studies. Am J Transplant 2004; 4: 626.
7. Leone J, Vítko S, Whelchel J, et al. Excellent graft function in de novo kidney transplant recipients treated with Certican, Simulect and reduced Neoral exposure: 24 month results. Am J Transplant 2005; 5(Suppl 11): A1010.
8. Pascual J, Cambi V, Dissegna D, et al. Efficacy and safety of 2 doses of everolimus combined with reduced dose Neoral in de novo kidney transplant recipients: 24 Months analysis. Am J Transplant 2005; 5(Suppl 11): A1010.
9. Magee J, Tedesco H, Pascual J, et al. Efficacy and safety of 2 doses of everolimus combined with reduced-dose Neoral in de novo kidney transplant recipients: 12 Month analysis [abstract 504]. Am J Transplant 2004; 4(Suppl 8): 296.
10. Whelchel J, Vitko S, Eris J, et al. Excellent graft function in de novo kidney transplant recipients treated with Certican, Simulect and reduced Neoral exposure. 12-Month results. Am J Transplant 2004; 4(Suppl 8): 297 [abstract 507].
11. Kovarik JM, Kaplan B, Tedesco Silva H, et al. Exposure-response relationships for everolimus in de novo kidney transplantation: Defining a therapeutic range. Transplantation 2002; 73: 920.
12. Kovarik JM, Tedesco H, Pascual J. Everolimus therapeutic concentration range defined from a prospective trial with reduced-exposure cyclosporine in de novo kidney transplantation. Ther Drug Monit 2004; 26: 499.
13. Chan L, Greenstein S, Hardy MA, et al. Multicenter, randomized study of the use of everolimus with tacrolimus after renal transplantation demonstrates its effectiveness. Transplantation 2008; 85: 821.
14. Kovarik JM, Kalbag J, Figueiredo J, et al. Differential influence of two cyclosporine formulations on everolimus pharmacokinetics: A clinically relevant pharmacokinetic interaction. J Clin Pharmacol 2002; 42: 95.
15. Kovarik JM, Kaplan B, Silva HT, et al. Pharmacokinetics of an everolimus-cyclosporine immunosuppressive regimen over the first 6 months after kidney transplantation. AmJTransplant 2003; 3:606.
16. Budde K, Lehne G, Winkler M, et al. Influence of everolimus on steady-state pharmacokinetics of cyclosporine in maintenance renal transplant patients. J Clin Pharmacol 2005; 45: 781.
17. Neylan JF. Racial differences in renal transplantation after immunosuppression with tacrolimus versus cyclosporine. FK506 kidney transplant study group. Transplantation 1998; 65: 515.
18. Katznelson S, Gjertson DW, Cecka JM. The effect of race and ethnicity on kidney allograft outcome. Clin Transpl 1995; 379
19. Study A2426.ClinicalTrials.gov. Available at: http://clinicaltrials.gov/ ct2/show/NCT00369161term = CRAD001A2426&rank= 1. Accessed June 2009.
20. Kovarik JM, Curtis JJ, Hricik DE, et al. Differential pharmacokinetic interaction of tacrolimus and cyclosporine on everolimus. Tranplant Proc 2006; 38: 3456.
21. Brandhorst G, Tenderich G, Zittermann A, et al. Everolimus exposure in cardiac transplant recipients is influenced by concomitant cal-cineurin inhibitor. Ther Drug Monit 2008; 30: 113.