Everolimus in de novo cardiac transplantation: Pharmacokinetics, therapeutic range, and influence on cyclosporine exposure

Journal of Heart and Lung Transplantation

Volumn 22, Issue 10, 2003, Pages 1117-1125

  Kovarik, John M ^a   Eisen, Howard ^b   Dorent, Richard ^c   Mancini, Donna ^d   Vigano, Mario ^e   Rouilly, Marisel ^a   Hsu, Chyi Hung ^a   Rordorf, Christiane ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

^b TEMPLE UNIVERSITY   (United States)

^c PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^d New York Presbyterian Hospital Columbia University Medical Center   (United States)

^e FONDAZIONE IRCCS POLICLINICO SAN MATTEO   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

AZATHIOPRINE; CHOLESTEROL; CORTICOSTEROID; CREATININE; CYCLOSPORIN; EVEROLIMUS; LOW DENSITY LIPOPROTEIN; NEVORAL; TRIACYLGLYCEROL;

ACUTE GRAFT REJECTION; ADULT; AGE; AREA UNDER THE CURVE; ARTICLE; BODY WEIGHT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG EFFECT; DRUG EFFICACY; DRUG EXPOSURE; DRUG FORMULATION; DRUG RESPONSE; DRUG SAFETY; FEMALE; GENDER; HEART MUSCLE BIOPSY; HEART TRANSPLANTATION; HUMAN; HYPERCHOLESTEROLEMIA; HYPERLIPIDEMIA; HYPERTRIGLYCERIDEMIA; LEUKOCYTE COUNT; LEUKOPENIA; LONGITUDINAL STUDY; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; PARAMETER; PHASE 3 CLINICAL TRIAL; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTE COUNT; THROMBOCYTOPENIA;

EID: 0141433268     PISSN: 10532498     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1053-2498(02)01221-4     Document Type: Article

References (14)

1. Vitko S., Margreiter R., Weimar W., et al. International, double-blind, parallel-group study of the safety and efficacy of Certican versus mycophenolate mofetil in combination with Neoral and steroids (abstract). Am J Transplant. 1:(suppl1):2001;474.
2. Kaplan B., Tedesco Silva H., Mendez R., Kahan B., Van Buren D., Boger R. North/South American, double-blind, parallel-group study of the safety and efficacy of Certican versus mycophenolate mofetil in combination with Neoral and corticosteroids (abstract). Am J Transplant. 1:(suppl1):2001;475.
3. Valantine H., Eisen H., Dorent R., et al. Twelve-month results of a multicenter study comparing efficacy and safety of everolimus to azathioprine in de novo cardiac transplant recipients (abstract). Am J Transplant. 2:(suppl3):2002;247.
4. Tuzcu E.M., Starling R., Dorent R., et al. Everolimus reduced cardiac allograft vasculopathy the heart intravascular ultrasound study (abstract) . Am J Transplant. 2:(suppl3):2002;459.
5. Nashan B. Role of Certican in the many pathways of chronic rejection. Transplant Proc. 33:2001;3215-3220.
6. Kovarik J.M., Kahan B.D., Kaplan B., et al. Longitudinal assessment of everolimus in de novo kidney transplant recipients over the first post-transplant year pharmacokinetics, exposure-response relationships, and influence on cyclosporine . Clin Pharmacol Ther. 69:2001;48-56.
7. Schuirmann D.J. Comparison of the two one-sided tests procedure and the power approach for assessing the bioequivalence of average bioavailability. J Pharmacokinet Biopharm. 15:1987;657-680.
8. Chou T., Talalay P. Quantitative analysis of dose-effect relationships the combined effects of multiple drugs or enzyme inhibitors . Adv Enzyme Regul. 22:1984;27-55.
9. Thompson M.L., Zucchini W. On the statistical analysis of ROC curves. Stat Med. 8:1989;1277-1290.
10. 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;920-925.
11. Kovarik J.M., Mueller E.A., Richard F., et al. Evidence for earlier stabilization of cyclosporine pharmacokinetics in de novo renal transplant patients receiving a microemulsion formulation. Transplantation. 62:1996;759-763.
12. Hong J.C., Kahan B.D. Sirolimus-induced thrombocytopenia and leukopenia in renal transplant recipients risk factors, incidence, progression, and management . Transplantation. 69:2000;2085-2090.
13. Kahan B.D. Efficacy of sirolimus compared with azathioprine for reduction of acute renal allograft rejection a randomised multicentre study . Lancet. 356:2000;194-202.
14. Kahan BD, Kaplan B, Lorber MI, et al. RAD in de novo renal transplantation: comparison of three doses on the incidence and severity of acute rejection. Transplantation 2001;71:1400-6.