1. Results of lis2t, a multicenter, randomized study comparing cyclosporine microemulsion with C2 monitoring and tacrolimus with C0 monitoring in de novo liver transplantation
- Author
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Levy, G, Villamil, F, Samuel, D, Sanjuan, F, Grazi, GIAN LUCA, Wu, Y, Marotta, P, Boillot, O, Muehlbacher, F, Klintmalm, G, LIST STUDY GROUP, LEVY G, VILLAMIL F, SAMUEL D, SANJUAN F, GRAZI G., WU Y, MAROTTA P, BOILLOT O, MUEHLBACHER F, KLINTMALM G, and LIST STUDY GROUP.
- Subjects
Adult ,Graft Rejection ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Biopsy ,Azathioprine ,Hepacivirus ,Liver transplantation ,Gastroenterology ,Tacrolimus ,NO ,Internal medicine ,medicine ,Diabetes Mellitus ,Humans ,Aged ,Monitoring, Physiologic ,Transplantation ,immunosuppression ,medicine.diagnostic_test ,business.industry ,Incidence ,Liver Diseases ,Hepatitis C ,Middle Aged ,medicine.disease ,Ciclosporin ,Surgery ,Liver Transplantation ,Calcineurin ,surgical procedures, operative ,Treatment Outcome ,Liver transplantation, immunosuppression, cyclosporine, tacrolimus ,Liver ,Therapeutic drug monitoring ,Cyclosporine ,Emulsions ,business ,Immunosuppressive Agents ,medicine.drug - 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, 89% 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%, P
- Published
- 2004