Benefit of Neoral C2 monitoring in de novo cardiac transplant recipients receiving basiliximab induction.

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. Purpose. 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 μmol/L (cohort A) or more than 170 μmol/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. Conclusion. 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.