title: Benefit of Neoral C2 monitoring in de novo cardiac transplant recipients receiving basiliximab induction.
abstract: BACKGROUND
  For cyclosporine (CsA), 2-hr postdose level (C2) is the best single time point predictor of the area under the curve and a critical measure for effective dosing. The therapeutic CsA microemulsion (Neoral) C2 range in de novo heart transplant patients remains to be determined.
  
  
  OBJECTIVE
  The purpose of this study was to determine the efficacy of CsA C2 monitoring in de novo heart transplant patients receiving basiliximab induction.
  
  
  METHODS
  This prospective, multicenter, randomized study enrolled 87 adult heart transplant recipients stratified according to 4 to 6 hrs posttransplant serum creatinine less than or equal to 170 micromol/L (cohort A) or more than 170 micromol/L (cohort B). Patients in cohort A were randomized into three C2 ranges (A1: "high" n=25, 1600-1800 ng/mL; A2: "intermediate" n=27, 1400-1600 ng/mL; and A3: "low" n=24, 1200-1400 ng/mL). Patients in cohort B were randomized into intermediate (n=5) and low C2 (n=6). Target ranges were progressively lowered after 1 month. Immunosuppression included basiliximab, Neoral, mycophenolate mofetil, and corticosteroids. Endpoints were acute rejection and renal function.
  
  
  RESULTS
  The incidence of acute rejection at 12 months was 44% in group A1, 41% in group A2, 33% in group A3, and 27% in cohort B. Pretransplant and 12-month creatinine clearance (mL/min) were group A1, 72+/-25 and 64+/-24; group A2, 81+/-32 and 68+/-25; group A3, 91+/-28 and 86+/-26; and cohort B, 62+/-28 and 79+/-37.
  
  
  CONCLUSIONS
  These results suggest that C2 monitoring is safe in de novo heart transplant patients. A low Neoral C2 range in combination with basiliximab induction resulted in preserved renal function without increased risk of acute rejection.
authors.affiliation: McGill University Health Center, Montréal, Canada.
authors.forename: Marcelo
authors.initials: M
authors.lastname: Cantarovich
authors.forename: Heather
authors.initials: H
authors.lastname: Ross
authors.forename: José M
authors.initials: JM
authors.lastname: Arizón
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Gómez
authors.forename: Lynn
authors.initials: L
authors.lastname: Straatman
authors.forename: Josefina
authors.initials: J
authors.lastname: Orús
authors.forename: Luis
authors.initials: L
authors.lastname: Alonso-Pulpón
authors.forename: Beatriz Díaz
authors.initials: BD
authors.lastname: Molina
authors.forename: Shaohua
authors.initials: S
authors.lastname: Wang
authors.forename: Ernesto
authors.initials: E
authors.lastname: Lage
authors.forename: María G
authors.initials: MG
authors.lastname: Crespo
authors.forename: Nicolás
authors.initials: N
authors.lastname: Manito
authors.forename: Jonathan
authors.initials: J
authors.lastname: Howlett
authors.forename: Haissam
authors.initials: H
authors.lastname: Haddad
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000077552:Basiliximab; D016572:Cyclosporine / Q000097:blood* / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000453:epidemiology; D016027:Heart Transplantation / Q000276:immunology* / Q000401:mortality; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use; D016019:Survival Analysis; D017741:Survivors; D013997:Time Factors
chemical_list: D000911:Antibodies, Monoclonal; D011993:Recombinant Fusion Proteins; D016572:Cyclosporine; D000077552:Basiliximab