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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(10):1464-72LT

Abstract

The LIS2T study was an open-label, multicenter study in which recipients of a primary liver transplant were randomized to cyclosporine microemulsion (CsA-ME) (Neoral) (n = 250) (monitoring of blood concentration at 2 hours postdose) C2 or tacrolimus (n = 245) (monitoring of trough drug blood level [predose]) C0 to compare efficacy and safety at 3 and 6 months and to evaluate patient status at 12 months. All patients received steroids with or without azathioprine. At 12 months, 85% of CsA-ME patients and 86% of tacrolimus patients survived with a functioning graft (P not significant). Efficacy was similar in deceased- and living-donor recipients. Significantly fewer hepatitis C-positive patients died or lost their graft by 12 months with CsA-ME (5/88, 6%) than with tacrolimus (14/85, 16%) (P < 0.03). Recurrence of hepatitis C virus in liver grafts was similar in each group. Based on biopsies driven by clinical events, the mean time to histological diagnosis of hepatitis C virus recurrence was significantly longer with CsA-ME (100 +/- 50 days) than with tacrolimus (70 +/- 40 days) (P < 0.05). Median serum creatinine at 12 months was 106 mumol/L with CsA-ME and with tacrolimus. More patients who were nondiabetic at baseline received antihyperglycemic therapy in the tacrolimus group at 12 months (13% vs. 5%, P < 0.01). Of patients who were diabetic at baseline, more tacrolimus-treated individuals required anti-diabetic treatment at 12 months (70% vs. 49%, P = 0.02). Treatment for de novo or preexisting hypertension or hyperlipidemia was similar in both groups. In conclusion, the efficacy of CsA-ME monitored by blood concentration at 2 hours postdose and tacrolimus in liver transplant patients is equivalent to 12 months, and renal function is similar. More patients required antidiabetic therapy with tacrolimus regardless of diabetic status at baseline.

Authors+Show Affiliations

University Health Network, Toronto General Hospital, Toronto, ON, Canada. glfgl2@attglobal.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

17004259

Citation

Levy, Gary, 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 Transplantation : Official Publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, vol. 12, no. 10, 2006, pp. 1464-72.
Levy G, Grazi GL, Sanjuan F, 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(10):1464-72.
Levy, G., Grazi, G. L., Sanjuan, F., Wu, Y., Mühlbacher, F., Samuel, D., ... McCormick, P. A. (2006). 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 Transplantation : Official Publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, 12(10), pp. 1464-72.
Levy G, 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(10):1464-72. PubMed PMID: 17004259.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Levy,Gary, AU - Grazi,Gian Luca, AU - Sanjuan,Fernando, AU - Wu,Youmin, AU - Mühlbacher,Ferdinand, AU - Samuel,Didier, AU - Friman,Styrbjorn, AU - Jones,Robert, AU - Cantisani,Guido, AU - Villamil,Federico, AU - Cillo,Umberto, AU - Clavien,Pierre Alain, AU - Klintmalm,Goran, AU - Otto,Gerd, AU - Pollard,Stephen, AU - McCormick,P Aiden, PY - 2006/9/28/pubmed PY - 2007/2/1/medline PY - 2006/9/28/entrez SP - 1464 EP - 72 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 - 12 IS - 10 N2 - The LIS2T study was an open-label, multicenter study in which recipients of a primary liver transplant were randomized to cyclosporine microemulsion (CsA-ME) (Neoral) (n = 250) (monitoring of blood concentration at 2 hours postdose) C2 or tacrolimus (n = 245) (monitoring of trough drug blood level [predose]) C0 to compare efficacy and safety at 3 and 6 months and to evaluate patient status at 12 months. All patients received steroids with or without azathioprine. At 12 months, 85% of CsA-ME patients and 86% of tacrolimus patients survived with a functioning graft (P not significant). Efficacy was similar in deceased- and living-donor recipients. Significantly fewer hepatitis C-positive patients died or lost their graft by 12 months with CsA-ME (5/88, 6%) than with tacrolimus (14/85, 16%) (P < 0.03). Recurrence of hepatitis C virus in liver grafts was similar in each group. Based on biopsies driven by clinical events, the mean time to histological diagnosis of hepatitis C virus recurrence was significantly longer with CsA-ME (100 +/- 50 days) than with tacrolimus (70 +/- 40 days) (P < 0.05). Median serum creatinine at 12 months was 106 mumol/L with CsA-ME and with tacrolimus. More patients who were nondiabetic at baseline received antihyperglycemic therapy in the tacrolimus group at 12 months (13% vs. 5%, P < 0.01). Of patients who were diabetic at baseline, more tacrolimus-treated individuals required anti-diabetic treatment at 12 months (70% vs. 49%, P = 0.02). Treatment for de novo or preexisting hypertension or hyperlipidemia was similar in both groups. In conclusion, the efficacy of CsA-ME monitored by blood concentration at 2 hours postdose and tacrolimus in liver transplant patients is equivalent to 12 months, and renal function is similar. More patients required antidiabetic therapy with tacrolimus regardless of diabetic status at baseline. SN - 1527-6465 UR - https://www.unboundmedicine.com/medline/citation/17004259/12_month_follow_up_analysis_of_a_multicenter_randomized_prospective_trial_in_de_novo_liver_transplant_recipients__LIS2T__comparing_cyclosporine_microemulsion__C2_monitoring__and_tacrolimus_ L2 - https://doi.org/10.1002/lt.20802 DB - PRIME DP - Unbound Medicine ER -