Recommendations for the Use of Everolimus (Certican) in Heart Transplantation: Results From the Second German-Austrian Certican Consensus Conference

Journal of Heart and Lung Transplantation

Volumn 26, Issue 4, 2007, Pages 305-311

  Rothenburger, Markus ^a   Zuckermann, Andreas ^b   Bara, Christoph ^c   Hummel, Manfred ^d   Strüber, Martin ^c   Hirt, Stephan ^e   Lehmkuhl, Hans ^f  

^a UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^b MEDICAL UNIVERSITY OF VIENNA   (Austria)

^c HANNOVER MEDICAL SCHOOL   (Germany)

^d Paulinenkrankenhaus ^*  (Germany)

^e UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^f DEUTSCHES HERZZENTRUM BERLIN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ATORVASTATIN; AZATHIOPRINE; CALCINEURIN INHIBITOR; CORTICOSTEROID; EVEROLIMUS; FLUINDOSTATIN; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PRAVASTATIN; PREDNISOLONE; RAPAMYCIN; SIMVASTATIN; TACROLIMUS;

ACNE; ANGIONEUROTIC EDEMA; ARTICLE; AUSTRIA; CARDIAC ALLOGRAFT VASCULOPATHY; CYTOMEGALOVIRUS INFECTION; DIABETES MELLITUS; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG INDICATION; DRUG MONITORING; DRUG SUBSTITUTION; DRUG WITHDRAWAL; GERMANY; GRAFT FAILURE; GRAFT REJECTION; HEART TRANSPLANTATION; HEPATITIS B; HUMAN; HYPERLIPIDEMIA; HYPERTENSION; IMMUNOSUPPRESSIVE TREATMENT; INTERSTITIAL PNEUMONIA; KIDNEY DYSFUNCTION; KIDNEY FAILURE; LIPID BLOOD LEVEL; NEPHROTOXICITY; NEUROTOXICITY; PRIORITY JOURNAL; PSORIASIS; RHABDOMYOLYSIS; SIDE EFFECT; SKIN MANIFESTATION; TREATMENT OUTCOME; TREMOR; WOUND HEALING IMPAIRMENT;

ANGIONEUROTIC EDEMA; CORONARY DISEASE; DRUG INTERACTIONS; DRUG MONITORING; HEART DISEASES; HEART TRANSPLANTATION; HUMANS; HYPERTENSION; IMMUNOSUPPRESSIVE AGENTS; KIDNEY FAILURE; LIPIDS; LUNG DISEASES, INTERSTITIAL; SIROLIMUS; SKIN DISEASES; TRANSPLANTATION, HOMOLOGOUS; WOUND HEALING;

EID: 33947681290     PISSN: 10532498     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.healun.2007.01.010     Document Type: Article

References (57)

1. Vitko 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 recipients. Am J Transplant 5 (2005) 2521-2530
2. Krämer B.K., Neumayer H.H., Stahl R., et al. Graft function, cardiovascular risk factors, and sex hormones in renal transplant recipients on an immunosuppressive regimen of everolimus, reduced dose of cyclosporine, and basiliximab. Transplant Proc 37 (2005) 1601-1604
3. Monaco A.P., and Morris P.J. Reduction in calcineurin inhibitor exposure and maintenance of effective immunosuppression: clinical experience with everolimus (Certican). Transplantation 79 suppl (2005) S67-S68
4. Lorber M.I., Mulgaonkar S., Butt K.M., et al. Everolimus versus mycophenolate mofetil in the prevention of rejection in de novo renal transplant recipients: a 3-year randomized, multicenter, Phase III study. Transplantation 80 (2005) 244-252
5. 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) 847-858
6. Vitko 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 4 (2004) 626-635
7. Tedesco H, Vitko S, Pascual J, et al. 12-month safety and efficacy of everolimus with reduced exposure cyclosporine in de novo renal transplant recipients. Transplant Int (in press).
8. Chapman T.M., and Perry C.M. Everolimus. Drugs 64 (2004) 861-872
9. Tedesco H., Pascual J., Magee J., et al. 36 month analysis on efficacy and safety of 2 doses of everolimus combined with reduced dose Neoral in de novo kidney transplant recipients (2006) Abstract 1281 of the World Transplant Congress, July, Boston, MA
10. Hummel M. Recommendations for use of Certican (everolimus) after heart transplantation: results from a German and Austrian Consensus Conference. J Heart Lung Transplant 24 suppl (2005) S196-S200
11. Starling R.C., Hare J.M., Hauptman P., et al. Therapeutic drug monitoring for everolimus in heart transplant recipients based on exposure-effect modeling. Am J Transplant 12 (2004) 2126-2131
12. Brignol N., McMahon L.M., Luo S., and Tse F.L. High-throughput semi-automated 96-well liquid/liquid extraction and liquid chromatography/mass spectrometric analysis of Everolimus (RAD001) and cyclosporine A (CsA) in whole blood. Rapid Commun Mass Spectrom 15 (2001) 898-907
13. Lehmkuhl H., and Hetzer R. Clinical experience with Certican (everolimus) in de novo heart transplant patients at the Deutsches Herzzentrum Berlin. J Heart Lung Transplant 24 suppl (2005) S201-S205
14. Zuckermann A. Clinical experience with Certican (everolimus) in maintenance heart transplant patients at the Medical University of Vienna. J Heart Lung Transplant 24 suppl (2005) S206-S209
15. Lehmkuhl H., Ross H., Eisen H., and Valantine H. Everolimus (Certican) in heart transplantation: optimizing renal function through minimizing cyclosporine exposure. Transplant Proc 37 (2005) 4145-4149
16. Eisen H., Kobashigawa J., Starling R.C., Valantine H., and Mancini D. Improving outcomes in heart transplantation: the potential of proliferation signal inhibitors. Transplant Proc 37 suppl (2005) 4S-17S
17. Valantine H. Cardiac allograft vasculopathy after heart transplantation: risk factors and management. J Heart Lung Transplant 23 suppl (2004) S187-S193
18. Schweiger M., Wasler A., Prenner G., et al. Everolimus and reduced cyclosporine trough levels in maintenance heart transplant recipients. Transplant Immunol 16 (2006) 46-51
19. Ross H., Burton J., Pflugfelder P., Dorent R., and Loertscher R. Neoral and Certican can safely be combined in stable cardiac transplant recipients: six week interim analysis of a Canadian pilot study. Transplant Int 18 suppl 1 (2005) PO097
20. Segovia J., Alonso-Pulpon L., Ortiz P., et al. Rapastat: evaluation of the role of oral sirolimus in the treatment of established graft vessel disease. A prospective, randomized intravascular ultrasound study. J Heart Lung Transplant 23 suppl 2 (2004) S51
21. Valantine H. Neoral use in the cardiac transplant recipient. Transplant Proc 32 suppl (2000) 27S-44S
22. Moien-Afshari F., McManus B.M., and Laher I. Immunosuppression and transplant vascular disease: benefits and adverse effects. Pharmacol Ther 100 (2003) 141-156
23. Keogh A., Macdonald P., Kaan A., Aboyoun C., Spratt P., and Mundy J. Efficacy and safety of pravastatin vs simvastatin after cardiac transplantation. J Heart Lung Transplant 19 (2000) 529-537
24. Yoshimura N., Oka T., Okamoto M., and Ohmori Y. The effects of pravastatin on hyperlipidemia in renal transplant recipients. Transplantation 53 (1992) 94-99
25. Kobashigawa J.A., Katznelson S., Laks H., et al. Effect of pravastatin on outcomes after cardiac transplantation. N Engl J Med 333 (1995) 621-627
26. Kobashigawa J.A., Moriguchi J.D., Laks H., et al. Ten-year follow-up of a randomized trial of pravastatin in heart transplant patients. J Heart Lung Transplant 24 (2005) 1736-1740
27. Wenke K., Meiser B., Thiery J., et al. Simvastatin reduces graft vessel disease and mortality after heart transplantation: a four-year randomized trial. Circulation 96 (1997) 1398-1402
28. Wenke K., Meiser B., Thiery J., et al. Simvastatin initiated early after heart transplantation: 8-Year prospective experience. Circulation 107 (2003) 93-97
29. Weis M., Pehlivanli S., Meiser B.M., and von Scheidt W. Simvastatin treatment is associated with improvement in coronary endothelial function and decreased cytokine activation in patients after heart transplantation. J Am Coll Cardiol 38 (2001) 814-818
30. Gregory C.R., Katznelson S., Griffey S.M., Kyles A.E., and Berryman E.R. Fluvastatin in combination with RAD significantly reduces graft vascular disease in rat cardiac allografts. Transplantation 72 (2001) 989-993
31. Fuchs U., Zittermann A., Berthold H.K., et al. Immunosuppressive therapy with everolimus can be associated with potentially life-threatening lingual angioedema. Transplantation 79 (2005) 981-983
32. Dean P.G., Lund W.J., Larson T.S., et al. Wound-healing complications after kidney transplantation: a prospective, randomized comparison of sirolimus and tacrolimus. Transplantation 77 (2004) 1555-1561
33. Kuppahally S., Al-Khaldi A., Weisshaar D., et al. Wound healing complications with de novo sirolimus versus mycophenolate mofetil-based regimen in cardiac transplant recipients. Am J Transplant 6 (2006) 986-992
34. Keogh A. Calcineurin inhibitors in heart transplantation. J Heart Lung Transplant 23 suppl (2004) S202-S206
35. Ponticelli C. Clinical experience with everolimus (Certican): a summary. Transplantation 79 suppl (2005) S93-S94
36. Hamour I.M., Mittal T.K., Bell A.D., and Banner N.R. Reversible sirolimus-associated pneumonitis after heart transplantation. J Heart Lung Transplant 25 (2006) 241-244
37. Delgado J.F., Torres J., Jose Ruiz-Cano M., et al. Sirolimus-associated interstitial pneumonitis in 3 heart transplant recipients. J Heart Lung Transplant 25 (2006) 171-174
38. Rehm B., Keller F., Mayer J., and Stracke S. Resolution of sirolimus-induced pneumonitis after conversion to everolimus. Transplant Proc 38 (2006) 711-713
39. Kovarik J.M., Beyer D., and Schmouder R.L. Everolimus drug interactions: application of a classification system for clinical decision making. Biopharm Drug Dispos 27 (2006) 421-426
40. Kovarik J.M., Beyer D., Bizot M.N., Jiang Q., Allison M.J., and Schmouder R.L. Pharmacokinetic interaction between verapamil and everolimus in healthy subjects. Br J Clin Pharmacol 60 (2005) 434-437
41. Kovarik J.M., Beyer D., Bizot M.N., Jiang Q., Shenouda M., and Schmouder R.L. Blood concentrations of everolimus are markedly increased by ketoconazole. J Clin Pharmacol 45 (2005) 514-518
42. Kovarik J.M., Beyer D., Bizot M.N., Jiang Q., Shenouda M., and Schmouder R.L. Effect of multiple-dose erythromycin on everolimus pharmacokinetics. Eur J Clin Pharmacol 61 (2005) 35-38
43. Hosenpud J.D., Novick R.J., Breen T.J., Keck B., and Daily P. The registry of the International Society for Heart and Lung Transplantation: twelfth official report: 1995. J Heart Lung Transplant 14 (1995) 805-815
44. Organ Procurement and Transplantation Network reports 1996-2001. Available at www.optn.org.
45. Schweiger M., Wasler A., Prenner G., Tripolt M., Schwarz M., and Tscheliessnigg K.H. Late acute cardiac allograft rejection: new therapeutic options?. Transplant Proc 37 (2005) 4528-4531
46. Lindenfeld J., Miller G.G., Shakar S.F., et al. Drug therapy in the heart transplant recipient. Part II: Immunosuppressive drugs. Circulation 110 (2004) 3858-3865
47. Valantine H. Prevention of cardiac allograft vasculopathy with Certican (everolimus): the Stanford University experience within the Certican Phase III clinical trial. J Heart Lung Transplant 24 suppl (2005) S191-S195
48. Pascual J., Marcen R., and Ortuno J. Clinical experience with everolimus (Certican): optimizing dose and tolerability. Transplantation 79 suppl (2005) S80-S84
49. Pascual J. Concentration-controlled everolimus (Certican): combination with reduced dose calcineurin inhibitors. Transplantation 79 suppl (2005) S76-S79
50. Neumayer H.H. Introducing everolimus (Certican) in organ transplantation: an overview of preclinical and early clinical developments. Transplantation 79 suppl (2005) S72-S75
51. Eisen H., and Ross H. Optimizing the immunosuppressive regimen in heart transplantation. J Heart Lung Transplant 23 (2004) S207-S213
52. Valantine H., and Zuckermann A. From clinical trials to clinical practice: an overview of Certican (everolimus) in heart transplantation. J Heart Lung Transplant 24 suppl (2005) S185-S190
53. Rothenburger M., Stypmann J., Loeher A., Huelsken G., Scheld H.H., Schmid C., et al. Calcineurin inhibitor-free immunosuppression using everolimus in maintenance heart transplant recipients-9 months follow-up (2006) Abstract 1449 of the World Transplant Congress, July, Boston, MA
54. Eris J. Clinical experience with everolimus (Certican) in young renal transplant recipients. Transplantation 79 suppl (2005) S89-S92
55. Pascual J., Marcen R., and Ortuno J. Clinical experience with everolimus (Certican) in elderly recipients: the "old-for-old" concept. Transplantation 79 suppl (2005) S85-S88
56. Ojo A.O., Held P.J., Port F.K., et al. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med 349 (2003) 931-940
57. Mancini D, Vigano M, Pulpon LA, et al. 24-month results of a multicenter study of everolimus for the prevention of allograft rejection and vasculopathy in de novo cardiac transplant recipients. Abstract 250318 of the American Transplant Congress, May/June 2003, Washington, DC.