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A randomized, prospective, pharmacoeconomic trial of neoral 2-hour postdose concentration monitoring versus tacrolimus trough concentration monitoring in de novo liver transplant recipients.
Liver Transpl 2008; 14(2):173-80LT

Abstract

Two-hour postdose cyclosporine (C2) monitoring is becoming an accepted method of therapeutic drug monitoring, although it is not known whether C2 monitoring is superior to tacrolimus (FK)-based immunosuppression. The purpose of this trial was to compare the safety, efficacy, and pharmacoeconomics of cyclosporine A (CsA) monitored by C2 levels versus FK monitored by trough levels in de novo liver transplant recipients. After informed consent, 60 de novo liver transplant recipients were randomized in a 1:1 fashion to receive either FK (trough, 6-10 ng/mL) or CsA (C2, 600-1200 ng/mL) and corticosteroids. The 2 groups were similar for gender, race, indication for liver disease, and age. At 1 year, patient survival was similar (93% for FK versus 90% for C2). One patient in the FK arm was retransplanted because of recurrent hepatitis C virus (HCV). Early acute rejection occurred in 27% of FK-treated patients and 23% of CsA-treated recipients [P = not significant (NS)]. Recurrent HCV occurred in 21% of FK-treated patients and 61% of CsA-treated patient (P = 0.04). The incidence of other infections, new onset diabetes mellitus, requirement for antihypertensives, and requirement for cholesterol medications were similar between the groups. Annual calcineurin inhibitor costs were lower in the C2 arm ($5432 +/- 2091 for C2 versus $8291 +/- 3948 for FK, P = 0.001). Annual pretransplant drug costs ($2292 +/- 2331 for C2 versus $2831 +/- 2358 for FK, P = NS) and 1-year posttransplant drug costs ($17,214 +/- 16,600 for C2 versus $15,151 +/- 11,699 for FK, P = NS) were similar. In conclusion, immunosuppression with CsA, monitored by C2 levels, is safe, effective, and economical in liver transplant recipients and provides immunosuppression at least equivalent to that of FK.

Authors+Show Affiliations

Department of Medicine, Washington University, Barnes-Jewish Hospital, St. Louis, MO 63110, USA. shenoysu@msnotes.wustl.edu

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18236391

Citation

Shenoy, Surendra, et al. "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 : Official Publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, vol. 14, no. 2, 2008, pp. 173-80.
Shenoy S, Hardinger KL, Crippin J, et al. A randomized, prospective, pharmacoeconomic trial of neoral 2-hour postdose concentration monitoring versus tacrolimus trough concentration monitoring in de novo liver transplant recipients. Liver Transpl. 2008;14(2):173-80.
Shenoy, S., Hardinger, K. L., Crippin, J., Korenblat, K., Lisker-Melman, M., Lowell, J. A., & Chapman, W. (2008). 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 : Official Publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, 14(2), pp. 173-80. doi:10.1002/lt.21355.
Shenoy S, et al. A Randomized, Prospective, Pharmacoeconomic Trial of Neoral 2-hour Postdose Concentration Monitoring Versus Tacrolimus Trough Concentration Monitoring in De Novo Liver Transplant Recipients. Liver Transpl. 2008;14(2):173-80. PubMed PMID: 18236391.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, prospective, pharmacoeconomic trial of neoral 2-hour postdose concentration monitoring versus tacrolimus trough concentration monitoring in de novo liver transplant recipients. AU - Shenoy,Surendra, AU - Hardinger,Karen L, AU - Crippin,Jeffrey, AU - Korenblat,Kevin, AU - Lisker-Melman,Mauricio, AU - Lowell,Jeffrey A, AU - Chapman,William, PY - 2008/2/1/pubmed PY - 2008/3/21/medline PY - 2008/2/1/entrez SP - 173 EP - 80 JF - Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society JO - Liver Transpl. VL - 14 IS - 2 N2 - Two-hour postdose cyclosporine (C2) monitoring is becoming an accepted method of therapeutic drug monitoring, although it is not known whether C2 monitoring is superior to tacrolimus (FK)-based immunosuppression. The purpose of this trial was to compare the safety, efficacy, and pharmacoeconomics of cyclosporine A (CsA) monitored by C2 levels versus FK monitored by trough levels in de novo liver transplant recipients. After informed consent, 60 de novo liver transplant recipients were randomized in a 1:1 fashion to receive either FK (trough, 6-10 ng/mL) or CsA (C2, 600-1200 ng/mL) and corticosteroids. The 2 groups were similar for gender, race, indication for liver disease, and age. At 1 year, patient survival was similar (93% for FK versus 90% for C2). One patient in the FK arm was retransplanted because of recurrent hepatitis C virus (HCV). Early acute rejection occurred in 27% of FK-treated patients and 23% of CsA-treated recipients [P = not significant (NS)]. Recurrent HCV occurred in 21% of FK-treated patients and 61% of CsA-treated patient (P = 0.04). The incidence of other infections, new onset diabetes mellitus, requirement for antihypertensives, and requirement for cholesterol medications were similar between the groups. Annual calcineurin inhibitor costs were lower in the C2 arm ($5432 +/- 2091 for C2 versus $8291 +/- 3948 for FK, P = 0.001). Annual pretransplant drug costs ($2292 +/- 2331 for C2 versus $2831 +/- 2358 for FK, P = NS) and 1-year posttransplant drug costs ($17,214 +/- 16,600 for C2 versus $15,151 +/- 11,699 for FK, P = NS) were similar. In conclusion, immunosuppression with CsA, monitored by C2 levels, is safe, effective, and economical in liver transplant recipients and provides immunosuppression at least equivalent to that of FK. SN - 1527-6465 UR - https://www.unboundmedicine.com/medline/citation/18236391/A_randomized_prospective_pharmacoeconomic_trial_of_neoral_2_hour_postdose_concentration_monitoring_versus_tacrolimus_trough_concentration_monitoring_in_de_novo_liver_transplant_recipients_ L2 - https://doi.org/10.1002/lt.21355 DB - PRIME DP - Unbound Medicine ER -