title: Tacrolimus combined with two different corticosteroid-free regimens compared with a standard triple regimen in renal transplantation: one year observational results.
abstract: 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.
authors.affiliation: Transplantationszentrum, Klinikum der Universität Regensburg, Regensburg, Germany. bernhard.kraemer@marienhospital-herne.de
authors.forename: Bernhard K
authors.initials: BK
authors.lastname: Krämer
authors.forename: Marian
authors.initials: M
authors.lastname: Klinger
authors.forename: Zbigniew
authors.initials: Z
authors.lastname: Wlodarczyk
authors.forename: Marek
authors.initials: M
authors.lastname: Ostrowski
authors.forename: Karsten
authors.initials: K
authors.lastname: Midvedt
authors.forename: Sergio
authors.initials: S
authors.lastname: Stefoni
authors.forename: Franco
authors.initials: F
authors.lastname: Citterio
authors.forename: Frank
authors.initials: F
authors.lastname: Pietruck
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Squifflet
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Segoloni
authors.forename: Bernd
authors.initials: B
authors.lastname: Krüger
authors.forename: Heide
authors.initials: H
authors.lastname: Sperschneider
authors.forename: Bernhard
authors.initials: B
authors.lastname: Banas
authors.forename: Lars
authors.initials: L
authors.lastname: Bäckman
authors.forename: Markus
authors.initials: M
authors.lastname: Weber
authors.forename: Mario
authors.initials: M
authors.lastname: Carmellini
authors.forename: Ferenc
authors.initials: F
authors.lastname: Perner
authors.forename: Kerstin
authors.initials: K
authors.lastname: Claesson
authors.forename: Wojciech
authors.initials: W
authors.lastname: Marcinkowski
authors.forename: Stefan
authors.initials: S
authors.lastname: Vítko
authors.forename: Grzegorz
authors.initials: G
authors.lastname: Senatorski
authors.forename: Kaija
authors.initials: K
authors.lastname: Salmela
authors.forename: Johan
authors.initials: J
authors.lastname: Nordström
mesh_terms: 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
chemical_list: D000911:Antibodies, Monoclonal; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D009173:Mycophenolic Acid; D016559:Tacrolimus; D008775:Methylprednisolone