Effect of fenofibrate on amputation events in people with type 2 diabetes mellitus (field study): A prespecified analysis of a randomised controlled trial
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Publication: Internal Medicine Journal
Start Page: 13
Introduction: Amputations in people with type 2 diabetes mellitus substantially impair their quality of life and impose high costs on health-care systems. Our aim was to assess the effect of fenofibrate on amputation events in a large cohort of patients with type 2 diabetes.
Methods: In the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, 9795 patients aged 50-75 years with type 2 diabetes were randomly assigned to receive fenofibrate 200 mg per day (n = 4895) or matching placebo (n = 4900) for 5 years’ duration. Information about nontraumatic amputation was routinely gathered. Amputations were adjudicated as minor or major (below or above the ankle, respectively). Amputations were also classified on the basis of whether or not large-vessel disease was present in the limb, to distinguish those related to large-artery atherosclerosis from those predominantly related to microvascular disease.
Results: 115 patients had one or more non-traumatic lower-limb amputations due to diabetes. The risks of first amputation (45 vs 70 events; hazard ratio [HR] 064, 95% CI 044-094; p = 002) and minor amputation events without known large-vessel disease (18 vs 34 events; 053, 030-094; p = 0027) 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; 093, 053-162; p = 079).
Conclusion: Treatment with fenofibrate was associated with a lower risk of amputations, particularly minor amputations without known large-vessel disease, probably through non-lipid mechanisms. These findings could lead to a change in standard treatment for the prevention of diabetes-related lower-limb amputations.