Once-daily prolonged-release tacrolimus (ADVAGRAF) versus twice-daily tacrolimus (PROGRAF) in liver transplantation.
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Once-daily prolonged-release tacrolimus (ADVAGRAF) versus twice-daily tacrolimus (PROGRAF) in liver transplantation. / Boillot, O; Seehofer, D; Pinna, A D; Fischer, L; Fischer, Lutz; Troisi, R I; Baccarani, U; Ortiz de Urbina, J; Wall, W; Group, Tacrolimus Prolonged Release Liver Study.
In: AM J TRANSPLANT, Vol. 10, No. 10, 10, 2010, p. 2313-2323.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Once-daily prolonged-release tacrolimus (ADVAGRAF) versus twice-daily tacrolimus (PROGRAF) in liver transplantation.
AU - Boillot, O
AU - Seehofer, D
AU - Pinna, A D
AU - Fischer, L
AU - Fischer, Lutz
AU - Troisi, R I
AU - Baccarani, U
AU - Ortiz de Urbina, J
AU - Wall, W
AU - Group, Tacrolimus Prolonged Release Liver Study
PY - 2010
Y1 - 2010
N2 - 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.
AB - 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.
KW - Adult
KW - Humans
KW - Male
KW - Female
KW - Middle Aged
KW - Treatment Outcome
KW - dosage
KW - Kidney Function Tests
KW - Tacrolimus administration
KW - Immunosuppressive Agents administration
KW - Liver Transplantation immunology
KW - Graft Rejection
KW - Adult
KW - Humans
KW - Male
KW - Female
KW - Middle Aged
KW - Treatment Outcome
KW - dosage
KW - Kidney Function Tests
KW - Tacrolimus administration
KW - Immunosuppressive Agents administration
KW - Liver Transplantation immunology
KW - Graft Rejection
M3 - SCORING: Zeitschriftenaufsatz
VL - 10
SP - 2313
EP - 2323
JO - AM J TRANSPLANT
JF - AM J TRANSPLANT
SN - 1600-6135
IS - 10
M1 - 10
ER -
