FIELD study - Can we reduce the amputations in Diabetic population with Fenofibrate?

Diabetes mellitus is the leading cause of non-traumatic lower-extremity amputations in the developed world. In the USA in 2001, at least one amputation due to diabetes occurred every 2 h, with an annual cost exceeding US$1·6 billion.Despite rigorous management of reversible factors, probably around one in ten patients with diabetes will eventually need at least one amputation. Neither control of glycaemia or blood pressure nor lowering of cholesterol has prevented the risk of amputation, underscoring the importance of assessing the management of other potential risk factors. Any further therapeutic option to prevent the morbidity and mortality associated with amputation would be highly desirable. In the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, 9795 patients aged 50—75 years with type 2 diabetes were randomly assigned by computer-generated randomisation sequence to receive fenofibrate 200 mg per day (n=4895) or matching placebo (n=4900) for 5 years' duration. Information about non-traumatic amputation—a prespecified tertiary endpoint of the study—was routinely gathered.The risks of first amputation (45 vs 70 events; hazard ratio [HR] 0·64, 95% CI 0·44—0·94; p=0·02) and minor amputation events without known large-vessel disease (18 vs 34 events; 0·53, 0·30—0·94; p=0·027) were lower for patients assigned to fenofibrate than for patients assigned to placebo, with no difference between groups in risk of major amputations (24 vs 26 events; 0·93, 0·53—1·62; p=0·79)