Abstract 983: Protection Against Nephropathy With Fenofibrate in Type 2 Diabetes Mellitus: The FIELD Study
Background: Diabetic nephropathy is the leading cause of end-stage renal disease in industrialised countries and accounts for the deaths of 10 –20% of people with diabetes.
Objective: We explored the effects of long-term fenofibrate on progression of nephropathy among people with type 2 diabetes mellitus in the FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) trial.
Methods: Progression of nephropathy, as determined by albuminuria and glomerular filtration rate (eGFR), were prespecified tertiary endpoints of the FIELD study. Albuminuria category was defined by urinary albumin: creatinine ratio (ACR), with microalbuminuria defined as ACR >2.5 mg albumin/mmol creatinine (male), >3.5 (female); and macroalbuminuria as >25 mg albumin/mmol creatinine (male), >35 (female) respectively. eGFR used the MDRD formula. Among 661 subjects, eGFR was measured 8 weeks after study treatment had been withdrawn at the end of 5 years.
Results: Among all 9795 study patients, albuminuria on average progressed 15% less frequently and was reversed 16% more often among those allocated to receive fenofibrate than placebo (P=0.0009). Blood creatinine rose about 12% on average during fenofibrate treatment, and this elevation persisted throughout the trial, but fell again to below placebo-treatment levels over the 8 weeks after fenofibrate therapy was withdrawn (661-subject subset) (P<0.001). Calculated GFR at this time was also higher among those who had received active fenofibrate: eGFR changes between baseline and after the study were: placebo: −6.90 mL/min (−7.2%); P<0.001, and fenofibrate: −1.94 mL/min (−1.6%); P=0.07; difference in change between groups −4.96 mL/min; P=0.001.
Conclusions: Albuminuria was reduced among those receiving fenofibrate. eGFR may fall during fenofibrate treatment. However, in the substudy, significantly lesser loss of renal function, as measured by serum creatinine and eGFR, had occurred among those receiving fenofibrate than those receiving placebo over 5 years. This suggests that fenofibrate may protect against the loss of underlying renal function seen in type 2 diabetes.