Tacrolimus combined with two different corticosteroid-free regimens compared with a standard triple regimen in renal transplantation: one year observational results.
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.
Krämer
Bernhard K
BK
Transplantationszentrum, Klinikum der Universität Regensburg, Regensburg, Germany. bernhard.kraemer@marienhospital-herne.de
Klinger
Marian
M
Wlodarczyk
Zbigniew
Z
Ostrowski
Marek
M
Midvedt
Karsten
K
Stefoni
Sergio
S
Citterio
Franco
F
Pietruck
Frank
F
Squifflet
Jean-Paul
JP
Segoloni
Giuseppe
G
Krüger
Bernd
B
Sperschneider
Heide
H
Banas
Bernhard
B
Bäckman
Lars
L
Weber
Markus
M
Carmellini
Mario
M
Perner
Ferenc
F
Claesson
Kerstin
K
Marcinkowski
Wojciech
W
Vítko
Stefan
S
Senatorski
Grzegorz
G
Salmela
Kaija
K
Nordström
Johan
J
D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D000077552:Basiliximab; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage*; D006084:Graft Rejection; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007676:Kidney Failure, Chronic / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D016030:Kidney Transplantation; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage; D015996:Survival Rate; D016559:Tacrolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D009173:Mycophenolic Acid; D016559:Tacrolimus; D008775:Methylprednisolone