A randomized, prospective, pharmacoeconomic trial of neoral 2-hour postdose concentration monitoring versus tacrolimus trough concentration monitoring in de novo liver transplant recipients

Liver Transplantation

Volumn 14, Issue 2, 2008, Pages 173-180

  Shenoy, Surendra ^a   Hardinger, Karen L ^c   Crippin, Jeffrey ^b   Karenblat, Kevin ^b   Lisker Melman, Mauricio ^b   Lowell, Jeffrey A ^a   Chapman, William ^a  

^a WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b WASHINGTON UNIVERSITY   (United States)

^c UNIVERSITY OF MISSOURI KANSAS CITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACICLOVIR; ANTIDIABETIC AGENT; ANTIHYPERTENSIVE AGENT; ANTILIPEMIC AGENT; CALCINEURIN INHIBITOR; CORTICOSTEROID; COTRIMOXAZOLE; CYCLOSPORIN A; GANCICLOVIR; IMMUNOGLOBULIN; INSULIN; METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; NYSTATIN; PENTAMIDINE; PREDNISONE; RAPAMYCIN; TACROLIMUS; VALGANCICLOVIR;

ACUTE GRAFT REJECTION; ADULT; AGE; ARTICLE; BACTERIAL INFECTION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST BENEFIT ANALYSIS; CYTOMEGALOVIRUS INFECTION; DIABETES MELLITUS; DOSE TIME EFFECT RELATION; DRUG BLOOD LEVEL; DRUG COST; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG MONITORING; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; DYSLIPIDEMIA; FEMALE; GENDER; GRAFT RECIPIENT; GRAFT SURVIVAL; HEPATITIS B; HEPATITIS C; HEPATITIS C VIRUS; HERPES SIMPLEX; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; HYPERLIPIDEMIA; HYPERTENSION; INFECTION; INFORMED CONSENT; KIDNEY FAILURE; LIVER CARCINOMA; LIVER FAILURE; LIVER GRAFT REJECTION; LIVER TOXICITY; LIVER TRANSPLANTATION; LOW DRUG DOSE; LYMPHOPROLIFERATIVE DISEASE; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; MYCOSIS; NAUSEA; PNEUMOCYSTIS PNEUMONIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; PSYCHOSIS; RACE; RANDOMIZED CONTROLLED TRIAL; RECURRENT DISEASE; REOPERATION; SEIZURE; SURVIVAL RATE; SURVIVAL TIME;

ADRENAL CORTEX HORMONES; ADULT; COST-BENEFIT ANALYSIS; CYCLOSPORINE; DRUG COSTS; DRUG MONITORING; FEMALE; GRAFT REJECTION; GRAFT SURVIVAL; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LIVER DISEASES; LIVER TRANSPLANTATION; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; TACROLIMUS; TIME FACTORS;

EID: 39449094294     PISSN: 15276465     EISSN: 15276473     Source Type: Journal    
DOI: 10.1002/lt.21355     Document Type: Article

References (20)

1. Mahalati K, Belitsky P, West K, Kiberd B, Fraser A, Sketris I, et al. Comparison of Neoral dose monitoring with cyclosporine trough levels versus 2-hr postdose levels in stable liver transplant patients. J Am Soc Nephrol 2001; 12:828-833.
2. Levy G, Thervet E, Lake J, Uchida K, for the CONCERT group. Patient management by Neoral C2 monitoring: an international consensus statement. Transplantation 2002;73(suppl):S12-S18.
3. Cantarovich M, Barkun JS, Tchervenkov JI, Besner J-G, Aspeslet L, Metrakos P. Comparison of Neoral dose monitoring with cyclosporine trough levels versus 2-hr postdose levels in stable liver transplant patients. Transplantation 1998;66:1621-1627.
4. Cantarovich M, Besner J-G, Barkun JS, Elstein E, Loertscher R. Two-hour cyclosporine level determination is the appropriate tool to monitor Neoral therapy. Clin Transplant 1998;12:243-249.
5. Levy G, Burra P, Cavallari A, Duvoux C, Lake J, Mayer AD, et al. Improved clinical outcomes for liver transplant recipients using cyclosporine monitoring based on 2-hr post-dose levels (C2). Transplantation 2002;73:953-959.
6. Stefoni S, Midtved K, Cole E, Thervet E, Cockfield S, Buchler M, et al. Efficacy and safety outcomes among de novo renal transplant recipients managed by C2 monitoring of cyclosporine a microemulsion: results of a 12-month, randomized, multicenter study. Transplantation 2005;79:577-583.
7. Levy G, Grazi GL, Sanjuan F, Wu Y, Mühlbacher F, Samuel D, et al. 12-month follow-up analysis of a multicenter, randomized, prospective trial in de novo liver transplant recipients (LIS2T) comparing cyclosporine microemulsion (C2 monitoring) and tacrolimus. Liver Transpl 2006;12: 1464-1472.
8. Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III): final report. Circulation 2002;106: 3143-3421.
9. Murray L, ed. 2003 Drug Topics Red Book. Montvale, NJ: Thomson PDR; 2003.
10. The U.S. Multicenter FK506 Liver Study Group. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression in liver transplantation. N Engl J Med 1994;331:1110-1115.
11. European FK506 Multicentre Liver Study Group. Randomized trial comparing tacrolimus (FK506) and cyclosporine in prevention of liver allograft rejection. Lancet 1994;344:423-428.
12. Rosen HR, O'Reilly PM, Shackleton CR, McDiarmid S, Holt C, Busuttil RW, et al. Graft loss following liver transplantation patients with chronic hepatitis C. Transplantation 1996;62:1773-1776.
13. Gane EJ, Portmann BC, Naoumov NV, Smith HM, Underhill JA, Donaldson PT, et al. Long-term outcome of hepatitis C infection after liver transplantation. N Engl J Med 1996;334:815-820.
14. Charlton MR, Seaberg EC, Wiesner RH, Everhart J, Zetterman R, Lake J, et al. Predictors of patient and graft survival following liver transplantation for hepatitis C. Hepatology 1998;28:823-830.
15. Kakumu S, Takayanagi M, Iwata K, Okumura A, Aiyama T, Ishikawa T, et al. Cyclosporine therapy affects amino-transferase activity but not hepatitis C virus RNA levels in chronic hepatitis C. J Gastroenterol Hepatol 1997; 12:62-66.
16. Zervos XA, Weppler D, Fragulidis GP, Torres MB, Nery JR, Khan MF, et al. Comparison of tacrolimus with micro-emulsion cyclosporine as primary immunosuppression in hepatitis C patients after liver transplantation. Transplantation 1998;65:1044-1046.
17. Gane EJ, Naoumov NV, Qian KP, Mondelli MU, Maertens G, Portmann BC, et al. A longitudinal analysis of hepatitis C virus replication following liver transplantation. Gastroenterology 1996;110:167-177.
18. Sheiner PA, Schwartz ME, Mor E, Schluger LK, Theise N, Kishikawa K, et al. Severe or multiple rejection episodes are associated with early recurrence of hepatitis C after orthotopic liver transplantation. Hepatology 1995;21:30-34.
19. Cole E, Maham N, Cardella C, Cattran D, Fenton S, Hamel J, et al. Clinical benefits of Neoral C2 monitoring in the long-term management of renal transplant recipients. Transplantation 2003;75:2086-2090.
20. Shepherd J, Jones J, Hartwell D, Davidson P, Price A, Waugh N. Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of mild chronic hepatitis C: a systematic review and economic evaluation. Health Technol Assess 2007;11:1-224.