A Comparison of Tacrolimus and Cyclosporine in Liver Transplantation: Effects on Renal Function and Cardiovascular Risk Status

Michael R. Lucey; Manal F. Abdelmalek; Rosemarie Gagliardi; Darla Granger; Curtis Holt; Igal Kam; Goran Klintmalm; Alan Langnas; Kirti Shetty; Andreas Tzakis; E. Steve Woodle

Disclosures

American Journal of Transplantation. 2005;5(5):1111-1119. 

In This Article

Materials and Methods

We conducted a retrospective chart review of consecutive liver allograft recipients at 11 U.S. transplant centers. Pediatric and adult recipients of primary-deceased, split-deceased or living-donor livers from January 1997 to September 1998 were included. The exclusionary criteria were: recipients of multiple organs, accessory liver transplants defined as an allogeneic supplement to the native liver and patients lost to follow-up prior to achieving an endpoint (graft loss or death). Primary outcomes included kidney function and cardiovascular risk profile over 3 years following transplantation. Specifically, the cardiovascular risk parameters examined included the following: systolic and diastolic blood pressure, calculated mean arterial pressure, use of anti-hypertensive agents, total serum cholesterol, LDL cholesterol, triglycerides, HDL cholesterol and the use of anti-hyperlipidemic agents. Data were collected for the first 3 years after transplantation or until graft loss (death due to graft failure). Data were analyzed according to the initial calcineurin inhibitor selected: tacrolimus or cyclosporine.

There were 1065 cases identified that met inclusion criteria. Data were recorded at 3-month interval in the first year after transplant and then at 6-month interval through 36 months. Data entry was validated via a multiple iteration process. Gaps in data collection were identified for three of the participating centers. Data for the cases that were missing in the three centers provided as much information as possible, with the following remaining as outstanding and unverified: switch information for primary immunosuppressive therapy (8 patients), oral corticosteroid dose (2 patients), unconfirmed patient weights (2 patients), unconfirmed triglyceride levels (1 patient) and two records not entered due to loss of follow-up.

This study was conducted in accordance with the Institutional Review Boards at the individual transplant centers.

Electronic data capture and result generation utilized Synapse AXON technology. Data were analyzed using the SAS System (SAS Institute Inc., Cary, NC) for Windows Release 8.02. Kaplan-Meier estimates were calculated for patient and graft survival and retransplantation rates and compared using the Wilcoxon rank-sum test. Acute rejection data were compared using the log-rank test;[11] switch of primary immunosuppressive therapy was compared with the chi square test. Causes of graft loss and death, pre-transplant diagnoses and percentage of patients receiving corticosteroids, anti-hypertensive and anti-hyperlipidemic agents and insulin were compared using Fisher's exact test. The Mann-Whitney U-test was used to compare serum creatinine, blood pressure and serum lipid measurements. Statistical tests used for comparison of patient demographics and characteristics are specified. Bonferroni correction was applied to repeated measures. Results are expressed as mean ± SD, except where indicated as median and range. p -values of less than 0.05 were considered statistically significant.

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