Abstract
BackgroundThe beneficial effects of early statin use in kidney transplant recipients, especially those on tacrolimus-based immunosuppression, are not well established. We evaluated the predictors of statin use following kidney transplantation and examined its association with patient and allograft survival.MethodsWe examined 615 consecutive patients who underwent kidney transplant at our institution between January 1998 and January 2002. Statin use was assessed at baseline and 3, 6, 9, and 12 months following kidney transplant. Patients were followed for allograft and patient survival.Results36% of the 615 kidney transplant recipients were treated with statin treatment. Statin use increased over the course of the study period. Older age, elevated body mass index, higher triglyceride levels, hypercholesterolemia, diabetes, history of myocardial infarction were associated with higher rates of statin use; elevated alkaline phosphatase levels and CMV IgG seropositivity were associated with less statin use. Older age, elevated BMI and hypercholesterolemia remained significant predictors of increased statin use after accounting for covariates using multiple regression. The early use of statins was not associated with improvements in unadjusted patient survival [HR 0.99; 95%CI 0.72-1.37] or graft survival [HR 0.97; 95% CI 0.76-1.24]. The risks of death and graft survival were not consistently reduced with exposure to statin using either adjusted models or propensity scores in Cox Proportional Hazards models.ConclusionsIn a kidney transplant population primarily receiving tacrolimus-based immunosuppression, early statin use was not associated with significantly improved graft or patient survival.
Highlights
The beneficial effects of early statin use in kidney transplant recipients, especially those on tacrolimus-based immunosuppression, are not well established
Study is the only randomized controlled trial of statins in kidney transplant patients [3]. This trial found no statistically significant benefit of fluvastatin compared to placebo in achieving the primary outcome of a reduction in major adverse cardiac events (MACE); in addition, no statistical difference was seen in the overall mortality or graft survival between the fluvastatin and placebo groups
A 2 year extension of the Assessment of LEscol Renal Transplantation (ALERT) trial showed that patients randomized to the fluvastatin group had a reduced risk of MACE; there remained no significant difference in overall mortality and graft loss between the groups [4]
Summary
Patient Population In this historical cohort study, we examined all 715 consecutive patients who received a renal transplant from either deceased or living donors at our institution between January 1998 and January 2002 and include follow-up until July 2005. 615 patients who survived and had a functioning graft a year after transplantation were included in the analysis to avoid immortality time bias. Additional covariates included patient demographics (age, gender, race), clinical factors (cause of ESRD, previous transplant, body mass index [BMI], BMI2, immunosuppressive protocol), and laboratory values (liver function tests, CMV and hepatitis B and C status, total cholesterol), year of transplantation, as well as donor factors (living or deceased, age, antigen matching) and transplant procedure characteristics (cold ischemia time and delayed graft function, defined as the need for dialysis in the first week following transplantation). Univariate and multivariate Cox proportional hazards models were used for time-to-event analyses to assess the crude and independent associations between statin use and study outcomes. The components of our fully adjusted models varied by outcome but included statin use and those factors significantly associated with patient and graft survival: age, sex, race, and if appropriate, body mass index (BMI), BMI2, donor type, diabetes, history of previous transplant, CMV IgG seropositivity, tolerance protocol, creatinine at 12 months, history of myocardial infarction (MI), severe liver disease (SLD), and presence of delayed graft function (DGF). Data are presented as means ± SD and reported as significant if p < 0.05
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