title: Differential risks for adverse outcomes 3 years after kidney transplantation based on initial immunosuppression regimen: a national study.
abstract: We examined integrated national transplant registry, pharmacy fill, and medical claims data for Medicare-insured kidney transplant recipients in 2000-2011 (n = 45 164) from the United States Renal Data System to assess the efficacy and safety endpoints associated with seven early (first 90 days) immunosuppression (ISx) regimens. Risks of clinical complications over 3 years according to IS regimens were assessed with multivariate regression analysis, including the adjustment for covariates and propensity for receipt of a nonreference ISx regimen. Compared with the reference ISx (thymoglobulin induction with tacrolimus, mycophenolate, and prednisone maintenance), sirolimus-based ISx was associated with significantly higher three-year risks of pneumonia (adjusted hazard ratio, aHR 1.45; P < 0.0001), sepsis (aHR 1.40; P < 0.0001), diabetes (aHR 1.21; P < 0.0001), acute rejection (AR; adjusted odds ratio, aOR 1.33; P < 0.0001), graft failure (aHR 1.78; P < 0.0001), and patient death (aHR 1.40; P < 0.0001), but reduced skin cancer risk (aHR 0.71; P < 0.001). Cyclosporine-based IS was associated with increased risks of pneumonia (aHR 1.17; P < 0.001), sepsis (aHR 1.16; P < 0.001), AR (aOR 1.43; P < 0.001), and graft failure (aHR 1.39; P < 0.001), but less diabetes (aHR 0.83; P < 0.001). Steroid-free ISx was associated with the reduced risk of pneumonia (aHR 0.89; P = 0.002), sepsis (aHR 0.80; P < 0.001), and diabetes (aHR 0.77; P < 0.001), but higher graft failure (aHR 1.35; P < 0.001). Impacts of ISx over time warrant further study to better guide ISx tailoring to balance the efficacy and morbidity.
authors: Washington University in St. Louis School of Medicine, Saint Louis, MO, USA. vikasD@wustl.edu.
authors: Vikas R
authors: http://orcid.org/0000-0001-8000-1385
authors: VR
authors: Dharnidharka
authors: Saint Louis University School of Medicine, Saint Louis, MO, USA.
authors: Mark A
authors: MA
authors: Schnitzler
authors: Saint Louis University School of Medicine, Saint Louis, MO, USA.
authors: Jiajing
authors: J
authors: Chen
authors: Washington University in St. Louis School of Medicine, Saint Louis, MO, USA.
authors: Daniel C
authors: DC
authors: Brennan
authors: Eastern Carolina University, Greeneville, NC, USA.
authors: David
authors: D
authors: Axelrod
authors: Johns Hopkins University, Baltimore, MD, USA.
authors: Dorry L
authors: DL
authors: Segev
authors: Washington University in St. Louis School of Medicine, Saint Louis, MO, USA.
authors: Kenneth B
authors: KB
authors: Schechtman
authors: Washington University in St. Louis School of Medicine, Saint Louis, MO, USA.
authors: Jie
authors: J
authors: Zheng
authors: Saint Louis University School of Medicine, Saint Louis, MO, USA.
authors: Krista L
authors: KL
authors: Lentine
mesh_terms: D000293:Adolescent; D000328:Adult; D016572:Cyclosporine / Q000627:therapeutic use; D003920:Diabetes Mellitus / Q000175:diagnosis; D005260:Female; D006801:Humans; D007165:Immunosuppression Therapy; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009173:Mycophenolic Acid / Q000627:therapeutic use; D011014:Pneumonia / Q000175:diagnosis; D051437:Renal Insufficiency / Q000601:surgery; D012306:Risk; D018805:Sepsis / Q000175:diagnosis; D020123:Sirolimus / Q000627:therapeutic use; D016559:Tacrolimus / Q000627:therapeutic use; D014481:United States; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine; D009173:Mycophenolic Acid; D020123:Sirolimus; D016559:Tacrolimus
keywords: Medicare; cancer; immunosuppression; infections; kidney transplant; registries