12-month follow-up analysis of a multicenter, randomized, prospective trial in de novo liver transplantation recipients (LIS2T) comparing cyclosporine microemulsion (C2 monitoring) and tacrolimus

Gary Levy, Gian Luca Grazi, Fernando Sanjuan, Youmin Wu, Ferdinand Mühlbacher, Didier Samuel, Styrbjorn Friman, Robert Jones, Guido Cantisani, Frederico Villamil, Umberto Cillo, Pierre Alain Clavien, Goran Klintmalm, Gerd Otto, Stephen Pollard, P. Aiden McCormick, V. Descalsi, A. Gadano, A. Villamil, P. AngusS. Lynch, G. A. Balderson, G. Jeffreys, B. Chester, R. Steininger, B. de Hemptinne, R. Troisi, M. L. Zanotelli, L. Leonardi, I. Boin, S. Mies, B. D. Guardia, L. Lilly, P. Marotta, W. Wall, K. Peltekian, A. Roy, D. Marleau, C. Scudamore, M. Yoshida, J. Tchervenkov, M. Cantarovich, O. Boillot, P. Bernard, Y. Calmus, F. Conti, D. Cherqui, C. Duvoux, C. Ducerf, R. Maar, J. Gugenheim, A. Myx, D. Neau-Cransac, K. Mouette, F. Saliba, L. Rostaing, N. Kamar, C. Moench, M. O'Rourke, D. D'Amico, G. Varotti, A. Maffei-Faccioli, G. Gerunda, R. Merenda, A. Risaliti, U. Baccarani, M. Rossi, P. Berloco, K. Tanaka, F. Oike, S. Munn, E. Gane, I. Brekke, K. M. Boberg, A. Bernardos, I. Garcia, V. Cuervas, J. M. Moreno, A. Rimola, I. Cirera, F. Sanjuan, M. Prieto, M. Salcedo, G. Clemente, B. Ericson, H. Gjertsen, G. Herlenius, Z. Kadry, D. Mayer, P. Hayes, J. Davidson, J. Hodgson, J. S. Bynon, G. Davis, J. Ortiz, C. Manzarbeita, R. Mennon, R. H. Weisner, Y. Wu, R. Y. Chensu, J. R. Lake, A. Humar

Research output: Contribution to journalArticle

83 Scopus citations

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) (Neural) (n = 250) (monitoring of blood concentration at 2 hours postdose) C2 or tacrolimus (n = 245) (monitoring of trough drug blood level[predose])Co 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% o tacrolimus patients survived with a functioning grat (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 95/ 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 μmol/L with CsA-ME and with tacrolimus. More patients who were nondiabetic at baseline received antihyperglycemic therapy in the tacrolimus group at 12 months was (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.

Original languageEnglish (US)
Pages (from-to)1464-1472
Number of pages9
JournalLiver Transplantation
Volume12
Issue number10
DOIs
StatePublished - Oct 2006

ASJC Scopus subject areas

  • Surgery
  • Hepatology
  • Transplantation

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    Levy, G., Grazi, G. L., Sanjuan, F., Wu, Y., Mühlbacher, F., Samuel, D., Friman, S., Jones, R., Cantisani, G., Villamil, F., Cillo, U., Clavien, P. A., Klintmalm, G., Otto, G., Pollard, S., McCormick, P. A., Descalsi, V., Gadano, A., Villamil, A., ... Humar, A. (2006). 12-month follow-up analysis of a multicenter, randomized, prospective trial in de novo liver transplantation recipients (LIS2T) comparing cyclosporine microemulsion (C2 monitoring) and tacrolimus. Liver Transplantation, 12(10), 1464-1472. https://doi.org/10.1002/lt.20802