EFFECTS OF TACROLIMUS ON HYPERLIPIDEMIA AFTER SUCCESSFUL RENAL-TRANSPLANTATION - A SOUTHEASTERN-ORGAN-PROCUREMENT-FOUNDATION MULTICENTER CLINICAL-STUDY

Background. Tacrolimus has been shown to have a less adverse effect on the lipid profiles of transplant patients when the drug is started as induction therapy, In order to determine the effect tacrolimus has on lipid profiles in stable cyclosporine-treated renal transplant patien ts with established hyperlipidemia, a randomized prospective study was undertaken by the Southeastern Organ Procurement Foundation, Methods. Patients of the 13 transplant centers, with cholesterol of 240 mg/dl or greater, who were at least 1 year posttransplant with stable renal function, were randomly assigned to remain on cyclosporine (control) o r converted to tacrolimus. Patients converted to tacrolimus were maint ained at a level of 5-15 ng/ml, and control patients remained at their previous levels of cyclosporine. Concurrent immunosuppressants were n ot changed, Levels of total cholesterol, triglycerides, total high-den sity lipoprotein, low-density lipoprotein (LDL), very-low-density lipo protein, and apoproteins A and B were monitored before conversion and at months 1, 3, and 6, Renal function and glucose control were evaluat ed at the beginning and end of the study (month 6), Results. A total o f 65 patients were enrolled; 12 patients failed to complete the study, None were removed as a result of acute rejection or graft failure, Fi fty-three patients were available for analysis (27 in the tacrolimus g roup and 26 controls). Demographics were not different between groups. In patients converted to tacrolimus treatment, there was a -55 mg/dl (-16%) (P=0.0031) change in cholesterol, a -48 mg/dl (-25%) (P=0.0014) change in LDL cholesterol, and a -36 mg/dl (-23%) (P=0.034) change in apolipoprotein B. There was no change in renal function, glycemic con trol, or incidence of new onset diabetes mellitus in the tacrolimus gr oup, Conclusion. Conversion from cyclosporine to tacrolimus can be saf ely done after successful transplantation. Introduction of tacrolimus to a stable renal patient does not effect renal function or glycemic c ontrol, Tacrolimus can lower cholesterol, LDL, and apolipoprotein B. C onversion to tacrolimus from cyclosporine should be considered in the treatment of posttransplant hyperlipidemia.