title: Tacrolimus-based, steroid-free regimens in renal transplantation: 3-year follow-up of the ATLAS trial.
abstract: BACKGROUND
  Long-term use of corticosteroids is associated with considerable morbidity, including cardiovascular and metabolic adverse effects.
  
  
  METHODS
  This study evaluated the long-term efficacy and safety of two steroid-free regimens compared with a triple immunosuppressive therapy in renal transplant recipients. This was a 3-year follow-up to a 6-month, open-label, randomized, multicenter study.
  
  
  RESULTS
  Data from 3 years were available for 421 (93.3%) of 451 patients in the original intent-to-treat population (143 tacrolimus/basiliximab [Tac/Bas], 139 tacrolimus/mycophenolate mofetil [Tac/MMF], and 139 tacrolimus/MMF/steroids [triple therapy]). In the time interval from 6 months to 3 years after transplantation, the incidence of biopsy-proven acute rejection was low and similar (Tac/Bas, 2.1%; Tac/MMF, 2.2%; triple therapy, 2.2%); Most rejection episodes occurred during the first 6 months of the study. Graft survival was high (Kaplan-Meier estimates: 92.7%, 92.5%, and 92.5%), as was patient survival (93.1%, 96.4%, and 97.0%). There were 10 graft losses (n=2, 4, and 4) and 12 patient deaths (n=5, 2, and 5). Renal function was well preserved throughout the study and similar between groups. There was a trend toward improved cardiovascular risk factors in the Tac/Bas group, including reduced total and low-density lipoprotein cholesterol and lower new-onset insulin use. There were no between-group differences in the incidence or type of adverse events.
  
  
  CONCLUSIONS
  Higher rates of acute rejection early in treatment were seen with the steroid-free regimens, but this did not translate into poorer long-term outcomes, such as graft and patient survival and renal function. A trend for a more favorable cardiovascular risk profile was observed for steroid-free immunosuppression with Tac/Bas.
authors.affiliation: V. Medizinische Klinik, Universitätsklinikum Mannheim, Medizinische Fakultät Mannheim der Universität Heidelberg, Mannheim, Germany. bernhard.kraemer@umm.de
authors.forename: Bernhard K
authors.initials: BK
authors.lastname: Krämer
authors.forename: Marian
authors.initials: M
authors.lastname: Klinger
authors.forename: Štefan
authors.initials: Š
authors.lastname: Vítko
authors.forename: Maciej
authors.initials: M
authors.lastname: Glyda
authors.forename: Karsten
authors.initials: K
authors.lastname: Midtvedt
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: Marek
authors.initials: M
authors.lastname: Ostrowski
authors.forename: Grzegorz
authors.initials: G
authors.lastname: Senatorski
authors.forename: Johan
authors.initials: J
authors.lastname: Nordström
authors.forename: Kaija
authors.initials: K
authors.lastname: Salmela
mesh_terms: D000208:Acute Disease; D000305:Adrenal Cortex Hormones / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000077552:Basiliximab; D001706:Biopsy; D016009:Chi-Square Distribution; D002908:Chronic Disease; D004359:Drug Therapy, Combination; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000276:immunology / Q000401:mortality / Q000517:prevention & control*; D006085:Graft Survival / Q000187:drug effects*; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000009:adverse effects / Q000276:immunology* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D018570:Risk Assessment; D012307:Risk Factors; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D009173:Mycophenolic Acid; D016559:Tacrolimus