TY - JOUR
T1 - Tacrolimus combined with two different corticosteroid-free regimens compared with a standard triple regimen in renal transplantation: one year observational results
AU - Krämer, Bk
AU - Klinger, M
AU - Wlodarczyk, Z
AU - Ostrowski, M
AU - Midvedt, K
AU - Stefoni, S
AU - Citterio, Franco
AU - Pietruck, F
AU - Squifflet, J
AU - Segoloni, G
AU - Krüger, B
AU - Sperschneider, H
AU - Banas, B
AU - Bäckman, L
AU - Weber, M
AU - Carmellini, M
AU - Perner, F
AU - Claesson, K
AU - Marcinkowski, W
AU - Vítko, S
AU - Senatorski, G
AU - Salmela, K
AU - Nordström, J.
PY - 2010
Y1 - 2010
N2 - Side effects of steroid use have led to efforts to minimize their use in transplantation. Two corticosteroid-free regimens were compared with a triple immunosuppressive therapy. Data from the original intent-to-treat (ITT) population (153 tacrolimus/basiliximab [Tac/Bas], 151 tacrolimus/MMF [Tac/MMF], and 147 tacrolimus/MMF/steroids [control]) were analyzed in a 12-month follow-up. Percentage of graft survival were 92.8%, 95.4%, and 95.9% (KM estimates 89.9%, 95.3%, 95.9%), percentage of surviving patients were 98.7%, 98.0%, and 100% (KM estimates 95.9%, 92.8%, and 100%). During months 7-12, graft loss occurred in 3 Tac/Bas, 2 Tac/MMF, and zero control patients, patient deaths in 1 Tac/Bas, 2 Tac/MMF, and zero control, and biopsy-proven acute rejection episodes in 4 Tac/Bas, 3 Tac/MMF, and zero control. Mean serum creatinine at month 12 was 141.9 +/- 69.6 microM, 144.0 +/- 82.1 microM, and 134.5 +/- 71.2 microM (ns). New-onset insulin use in previously non-diabetic patients at month 12 was 1/138, 6/127, and 4/126. Patient and graft survival as well as renal function at 12 months were not different between patient groups, despite considerably higher rates of acute rejection occurring within the first six months after transplantation in both steroid-free patient groups. Tac/Bas therapy might offer benefits in terms of a trend for a more favorable cardiovascular risk profile.
AB - Side effects of steroid use have led to efforts to minimize their use in transplantation. Two corticosteroid-free regimens were compared with a triple immunosuppressive therapy. Data from the original intent-to-treat (ITT) population (153 tacrolimus/basiliximab [Tac/Bas], 151 tacrolimus/MMF [Tac/MMF], and 147 tacrolimus/MMF/steroids [control]) were analyzed in a 12-month follow-up. Percentage of graft survival were 92.8%, 95.4%, and 95.9% (KM estimates 89.9%, 95.3%, 95.9%), percentage of surviving patients were 98.7%, 98.0%, and 100% (KM estimates 95.9%, 92.8%, and 100%). During months 7-12, graft loss occurred in 3 Tac/Bas, 2 Tac/MMF, and zero control patients, patient deaths in 1 Tac/Bas, 2 Tac/MMF, and zero control, and biopsy-proven acute rejection episodes in 4 Tac/Bas, 3 Tac/MMF, and zero control. Mean serum creatinine at month 12 was 141.9 +/- 69.6 microM, 144.0 +/- 82.1 microM, and 134.5 +/- 71.2 microM (ns). New-onset insulin use in previously non-diabetic patients at month 12 was 1/138, 6/127, and 4/126. Patient and graft survival as well as renal function at 12 months were not different between patient groups, despite considerably higher rates of acute rejection occurring within the first six months after transplantation in both steroid-free patient groups. Tac/Bas therapy might offer benefits in terms of a trend for a more favorable cardiovascular risk profile.
KW - Adult
KW - Antibodies, Monoclonal
KW - Drug Therapy, Combination
KW - Female
KW - Follow-Up Studies
KW - Glucocorticoids
KW - Graft Rejection
KW - Graft Survival
KW - Humans
KW - Immunosuppressive Agents
KW - Kidney Failure, Chronic
KW - Kidney Transplantation
KW - Male
KW - Methylprednisolone
KW - Middle Aged
KW - Mycophenolic Acid
KW - Recombinant Fusion Proteins
KW - Survival Rate
KW - Tacrolimus
KW - Treatment Outcome
KW - Adult
KW - Antibodies, Monoclonal
KW - Drug Therapy, Combination
KW - Female
KW - Follow-Up Studies
KW - Glucocorticoids
KW - Graft Rejection
KW - Graft Survival
KW - Humans
KW - Immunosuppressive Agents
KW - Kidney Failure, Chronic
KW - Kidney Transplantation
KW - Male
KW - Methylprednisolone
KW - Middle Aged
KW - Mycophenolic Acid
KW - Recombinant Fusion Proteins
KW - Survival Rate
KW - Tacrolimus
KW - Treatment Outcome
UR - http://hdl.handle.net/10807/32851
U2 - 10.1111/j.1399-0012.2009.01162.x
DO - 10.1111/j.1399-0012.2009.01162.x
M3 - Article
SN - 1399-0012
VL - 24
SP - E1-E1-9
JO - Clinical Transplantation
JF - Clinical Transplantation
ER -