By Kristina Rebelo
SAN DIEGO -- November 4, 2009 -- Long-term fenofibrate use may protect against the loss of underlying renal function in patients with type 2 diabetes, according to late-breaking trial results released at the American Society of Nephrology (ASN) Renal Week 2009.
"Even well-treated patients with diabetes carry high residual risks of both macrovascular and microvascular complications," explained lead investigator Anthony C. Keech, University of Sydney, Sydney, Australia, speaking here on October 30. Dr. Keech and colleagues explored the effect of long-term fenofibrate on renal function among patients with type 2 diabetes in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial.
Blood creatinine level and albuminuria are predictors of long-term risk of cardiovascular disease in patients with type 2 diabetes. In this study, microalbuminuria was defined as a urinary albumin-to-creatinine ratio greater than 2.5 mg albumin/mmol creatinine in males and greater than 3.5 mg albumin/mmol creatinine in females. Macroalbuminuria was defined as greater than 25 mg albumin/mmol creatinine in males and greater than 35 mg albumin/mmol creatinine in females.
The estimated glomerular filtration rate (eGFR) used the Modification of Diet in Renal Disease formula. Progression of nephropathy as measured by albuminuria and eGFR was the prespecified tertiary endpoint.
The study comprised 661 subjects and continued for 5 years; eGFR was repeated 8 weeks after study treatment ended.
Blood creatinine levels rose 12% with the fenofibrate treatment, and this elevation persisted throughout the trial. Blood creatinine fell again, however, at study completion, to below placebo levels over the 8 weeks post therapy (P < .001).
Calculated eGFR was also higher among those who had received fenofibrate. The eGFR changes from baseline to post study for placebo and fenofibrate were, respectively, -6.90 mL/min (-7.2%, P < .0001) and -1.94 mL/min (-1.6%; P = .07). The difference between the levels was -4.96 mL/min (P = .0003).
Among those receiving fenofibrate, albuminuria progressed 15% less frequently and reversed 16% more commonly (P = .0009).
Dr. Keech concluded that "creatinine can rise reversibly with fenofibrate treatment and eGFR may fall during fenofibrate treatment; however, in the substudy, those who had received fenofibrate had less loss of renal function over the 5 years. Albuminuria was reduced among those receiving fenofibrate."
[Presentation title: Effects of Fenofibrate on Measures of Renal Function in Type 2 Diabetes Mellitus: The FIELD Study. Abstract LB-004]
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