title: Outcomes in ethnic minority renal transplant recipients receiving everolimus versus mycophenolate: comparative risk assessment results from a pooled analysis.
abstract: BACKGROUND
  Everolimus (EVR) has demonstrated good efficacy after renal transplantation. Racial disparities in clinical outcomes after de novo renal transplantation are well documented; whether the efficacy of EVR varies based on recipient ethnicity is unknown. We conducted a comparative risk assessment of EVR by ethnicity.
  
  
  METHODS
  Data on 2004 renal transplant recipients from three EVR studies were pooled to identify the impact of ethnicity on efficacy outcomes across EVR dosing groups and control groups. Ethnic groups compared were African Americans, non-U.S. blacks, Asians, Hispanics, and Caucasians. EVR groups received either 1.5 or 3 mg per day, with either standard-dose cyclosporine or reduced-dose cyclosporine. Control groups received mycophenolic acid (MPA) with standard-dose cyclosporine. Composite efficacy failure endpoint was graft loss, death, biopsy-proven acute rejection, or lost to follow-up. Adjusted odds ratios were calculated using a logistic regression model.
  
  
  RESULTS
  The proportion of renal transplant recipients who met the composite endpoint was African Americans (46%), non-U.S. black (35%), Caucasian (31%), Hispanic (28%), and Asian (25%). The odds of meeting the composite endpoint were significantly (P=0.0001) greater for African Americans versus Caucasians but did not differ among the other ethnic groups (ethnic groups were only compared with Caucasians). EVR and MPA were associated with similar efficacy among each of the ethnic groups.
  
  
  CONCLUSIONS
  In this pooled data analysis in more than 2000 renal transplant recipients, EVR versus MPA resulted in similar composite endpoint incidence events across ethnicities. Consistent with previously published data, African Americans had poorer clinical outcomes. EVR is efficacious regardless of ethnicity.
authors.affiliation: 1 Georgetown University Hospital, Washington, DC. 2 Saint Barnabas Medical Center, Livingston, NJ. 3 El Centro de Trasplante del Hospital Auxilio Mutuo, Hato Rey, Puerto Rico. 4 Novartis Pharmaceuticals Corporation, East Hanover, NJ. 5 University of Utah School of Medicine, Salt Lake City, UT. 6 Address correspondence to: Keith Melancon, M.D., George Washington Medical Faculty Associates, 2150 Pennsylvania Avenue Northwest, Suite 6B-412, Washington, DC 20037.
authors.forename: Keith
authors.initials: K
authors.lastname: Melancon
authors.forename: Shamkant P
authors.initials: SP
authors.lastname: Mulgaonkar
authors.forename: Carlos
authors.initials: C
authors.lastname: Delcoro
authors.forename: Anne
authors.initials: A
authors.lastname: Wiland
authors.forename: Kevin
authors.initials: K
authors.lastname: McCague
authors.forename: Fuad S
authors.initials: FS
authors.lastname: Shihab
mesh_terms: D000328:Adult; D001741:Black or African American; D003404:Creatinine / Q000378:metabolism; D016572:Cyclosporine / Q000008:administration & dosage; D000068338:Everolimus; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000379:methods*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009173:Mycophenolic Acid / Q000627:therapeutic use*; D016017:Odds Ratio; D016032:Randomized Controlled Trials as Topic; D051437:Renal Insufficiency / Q000208:ethnology / Q000628:therapy*; D018570:Risk Assessment; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine; D000068338:Everolimus; D003404:Creatinine; D009173:Mycophenolic Acid; D020123:Sirolimus