Abstract 3693: Effects of fenofibrate on silent myocardial infarction, hospitalization for acute coronary syndromes and amputation in type 2 diabetes: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study
Objective: The FIELD study evaluated the effects of fenofibrate among 9795 individuals with type 2 diabetes in a randomized placebo-controlled trial over an average of five years of follow-up. A number of tertiary outcomes were pre-specified including silent myocardial infarction ([MI]: new Q-waves without clinical presentation), hospitalization for acute coronary syndromes (ACS) and non-traumatic amputations.
Methods: Routine ECGs were taken at baseline, two years, five years and study close-out, and analysed blinded to treatment allocation, ECG order and clinical outcome. ECGs were assessed in duplicate according to Minnesota-code criteria and any disagreements were resolved by a third reader. ACS was present if hospitalized for a coronary event with that discharge diagnosis and not meeting the study criteria for acute MI, after blinded adjudication by the Outcomes Assessment Committee. Amputations directly due to trauma were excluded.
Results: Approximately 40% of all MI events were silent, though with a smaller non-significant 15% reduction in silent events compared with more than 20% reduction (p=0.01) in clinical MI associated with allocation to fenofibrate treatment. Fenofibrate also significantly reduced both hospitalization for ACS and amputations.
Conclusions: Fewer ACS and silent MI events occurred among individuals allocated to long-term fenofibrate. Amputation was also significantly reduced, suggesting benefits on both macrovascular and microvascular-associated events. The reductions in these and other outcomes support considering fenofibrate use in type 2 diabetes.