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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. 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 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. 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.

journal_name

Transplantation

journal_title

Transplantation

authors

Cantarovich M,Ross H,Arizón JM,Gómez MA,Straatman L,Orús J,Alonso-Pulpón L,Molina BD,Wang S,Lage E,Crespo MG,Manito N,Howlett J,Haddad H,Motown Study Group.

doi

10.1097/TP.0b013e318169bf43

subject

Has Abstract

pub_date

2008-04-15 00:00:00

pages

992-9

issue

eissn

0041-1337

issn

1534-6080

pii

00007890-200804150-00013

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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