Results of LIS2T, a multicenter, ramdomized study comparing cyclosporine microemulsion with C2 monitoring and tacrolimus with C0 monitoring in de novo liver transplantation

Gary Levy, Federico Villamil, Didier Samuel, Fernando Sanjuan, Gian Luca Grazi, You Wu, Paul Marotta, Olivier Boillot, Ferdinand Muehlbacher, Goran Klintmalm

Research output: Contribution to journalArticle

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Abstract

This is the first multicenter, randomized, open-label study to compare the efficacy and safety of cyclosporine A microemulsion (CsA-ME) (Neoral, Novartis, Basel, Switzerland) with C2 monitoring versus tacrolimus in de novo liver transplant recipients. Patients were stratified according to hepatitis C virus status and randomized to receive CsA-ME (n=250) or tacrolimus (n=245) with steroids, with or without azathioprine. The primary endpoint was the incidence of biopsy-proven acute rejection (BPAR) at 3 months. Secondary endpoints included death or graft loss and safety evaluations at 6 months. The incidence of BPAR at 3 months was 26% in the CsA-ME group and 24% in the tacrolimus group (not significant). At 6 months, 890% of patients receiving CsA-ME and 88% of patients receiving tacrolimus were alive with a functioning graft. Among the hepatitis C virus-positive patients, there was no difference in BPAR, but death or graft loss was more frequent in those receiving tacrolimus (15% vs. 6%, P2 monitoring or tacrolimus in liver transplant recipients. The incidence of adverse events is comparable except for a significantly higher incidence of diabetes mellitus and diarrhea in the tacrolimus group. Both agents are effective primary immunosuppressants in liver transplant recipients.

Original languageEnglish
Pages (from-to)1632-1638
Number of pages7
JournalTransplantation
Volume77
Issue number11
DOIs
Publication statusPublished - Jun 15 2004

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Tacrolimus
Liver Transplantation
Cyclosporine
Multicenter Studies
Incidence
Transplants
Biopsy
Hepacivirus
Liver
Safety
Azathioprine
Immunosuppressive Agents
Switzerland
Diarrhea
Diabetes Mellitus
Steroids
Transplant Recipients

ASJC Scopus subject areas

  • Transplantation
  • Immunology

Cite this

Results of LIS2T, a multicenter, ramdomized study comparing cyclosporine microemulsion with C2 monitoring and tacrolimus with C0 monitoring in de novo liver transplantation. / Levy, Gary; Villamil, Federico; Samuel, Didier; Sanjuan, Fernando; Grazi, Gian Luca; Wu, You; Marotta, Paul; Boillot, Olivier; Muehlbacher, Ferdinand; Klintmalm, Goran.

In: Transplantation, Vol. 77, No. 11, 15.06.2004, p. 1632-1638.

Research output: Contribution to journalArticle

Levy, Gary ; Villamil, Federico ; Samuel, Didier ; Sanjuan, Fernando ; Grazi, Gian Luca ; Wu, You ; Marotta, Paul ; Boillot, Olivier ; Muehlbacher, Ferdinand ; Klintmalm, Goran. / Results of LIS2T, a multicenter, ramdomized study comparing cyclosporine microemulsion with C2 monitoring and tacrolimus with C0 monitoring in de novo liver transplantation. In: Transplantation. 2004 ; Vol. 77, No. 11. pp. 1632-1638.
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AU - Sanjuan, Fernando

AU - Grazi, Gian Luca

AU - Wu, You

AU - Marotta, Paul

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