Fenofibrate Found Safe in Diabetes With Renal Impairment

Reduced total cardiovascular events in patients with type 2 diabetes and moderate renal impairment

TUESDAY, Jan. 31 (HealthDay News) -- Long-term daily use of fenofibrate is beneficial for patients with type 2 diabetes and moderate renal impairment and is not associated with an increase in drug-related safety concerns compared with those with mild renal impairment, according to research published in the February issue of Diabetes Care.

Ru-Dee Ting, M.D., of the University of Sydney in Australia, and colleagues conducted the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) intent-to-treat study to investigate the effects of fenofibrate on cardiovascular and end-stage renal disease (ESRD) events. The FIELD study involved 9,795 patients with type 2 diabetes and at least moderate renal impairment who received either a fixed dose of 200 mg/day of fenofibrate or matching placebo for at least five years. The primary outcome was a composite of cardiovascular death, myocardial infarction, stroke, and coronary/carotid revascularization. ESRD events included plasma creatinine over 400 µmol/L, dialysis, renal transplant, or renal death.

The researchers found that, in the population of patients with type 2 diabetes and moderate renal impairment (estimated glomerular filtration rate 30 to 59 mL/min/1.73 m²), daily fenofibrate reduced total cardiovascular events by 11 percent over placebo, regardless of the patient's severity of renal impairment (hazard ratio, 0.89; 95 percent confidence interval, 0.80 to 0.99; P = 0.035). The rate of ESRD events was not statistically different between the treatment arms, and fenofibrate was not associated with any adverse safety signals.

"In the FIELD Study, fenofibrate did not increase cardiovascular disease or renal risk in the setting of mild or moderate renal impairment in type 2 diabetes, despite causing an elevation in plasma creatinine. In those with pre-existing moderate renal impairment, the cardiovascular disease benefits of fenofibrate were at least as great as in those with normal renal function, without any additional safety concerns," the authors write.

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