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Once-Daily Prolonged-Release Tacrolimus (ADVAGRAF) Versus Twice-Daily Tacrolimus (PROGRAF) in Liver Transplantation.

Author(s): Trunecka P, Boillot O, Seehofer D, Pinna AD, Fischer L, Ericzon BG, Troisi RI, Baccarani U, Ortiz de Urbina J, Wall W, for the Tacrolimus Prolonged Release Liver Study Group

Affiliation(s): Department of Hepatogastroenterology, IKEM, Prague, Czech Republic Hopital Edouard Herriot, Lyon, France Klinik Transplantationschirurgie, Berlin, Germany Policlinico S.Orsola-Malpighi, University of Bologna, Italy Department of Hepatobiliary and Transplant Surgery, University Medical Center Hamburg-Eppendorf, Germany Karolinska University Hospital Huddinge, Stockholm, Sweden Department of General and Hepatobiliary Surgery, Liver Transplantation Service, Ghent University Hospital Medical School, Gent, Belgium Department of Surgical Sciences, University of Udine, Italy Unidad de Trasplante Hepatico, Barakaldo, Spain London Health Sciences Centre, London, Canada.

Publication date & source: 2010-10, Am J Transplant., 10(10):2313-2323. Epub 2010 Sep 14.

The efficacy and safety of dual-therapy regimens of twice-daily tacrolimus (BID; Prograf) and once-daily tacrolimus (QD; Advagraf) administered with steroids, without antibody induction, were compared in a multicenter, 1:1-randomized, two-arm, parallel-group study in 475 primary liver transplant recipients. A double-blind, double-dummy 24-week period was followed by an open extension to 12 months posttransplant. The primary endpoint, event rate of biopsy-proven acute rejection (BPAR) at 24 weeks, was 33.7% for tacrolimus BID versus 36.3% for tacrolimus QD (Per-protocol set; p = 0.512; treatment difference 2.6%, 95% confidence interval -7.3%, 12.4%), falling within the predefined 15% noninferiority margin. At 12 months, BPAR episodes requiring treatment were similar for tacrolimus BID and QD (28.1% and 24.7%). Twelve-month patient and graft survival was 90.8% and 85.6% for tacrolimus BID and 89.2% and 85.3% for tacrolimus QD. Adverse event (AE) profiles were similar for both tacrolimus BID and QD with comparable incidences of AEs and serious AEs. Tacrolimus QD was well tolerated with similar efficacy and safety profiles to tacrolimus BID. (c)2010 The Authors Journal compilation(c)2010 The American Society of Transplantation and the American Society of Transplant Surgeons.

Page last updated: 2010-10-05

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