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OUR IMPACT
Fenofibrate provides substantial protection against sight-threatening eye disease, kidney and nerve damage, foot amputations, and some heart disease-related events. It is approved by the Therapeutic Goods Administration (Australia) and in the EU and US.
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BACKGROUND |
Patients with type 2 diabetes are at increased risk of cardiovascular disease. We designed the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study to assess the effect of fenofibrate on cardiovascular disease events in these patients. |
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STUDY OVERVIEW |
The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study was the world's largest study into the prevention of heart disease and stroke in patients with diabetes. The study aimed to find out whether treatment with Fenofibrate, a potent modifier at this time of blood lipid levels, would reduce the risk of fatal coronary heart disease in people with type 2 diabetes. The trial recruited 9,795 patients and followed them up over a period of five years. FIELD was a double-blind placebo-controlled trial conducted in Australia, New Zealand and Finland. A feature of the trial was its wide entry criteria to allow the results to be generalised to a population of typical patients with diabetes consulting general practitioners. The trial began recruiting patients in early 1998, and randomly assigned the last of its 9,795 participants in November 2000. Its five-year follow-up was completed in October 2005. Results were published in The Lancet in November 2005 and results for secondary and tertiary endpoints planned in the protocol have also been published. |
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PARTICIPANTS |
9,795 participants in Australia, Finland, New Zealand. |
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EXPERTISE |
FIELD was internationally managed by CTC. The protocol allowed for diverse contingencies. |
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FINDINGS |
Fenofibrate did not reduce deaths from heart disease however, the total number of cardiovascular disease events was statistically significantly lower (by 11% ) in the Fenofibrate allocated patients. Fenofibrate reduced heart attacks by about a quarter and it was also found to reduce the risk of amputation and threatened vision. Patients in the Fenofibrate group were also less likely to have revascularisation (bypass grafting procedures to remove arterial blockages) of coronary and other arteries. |
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DURATION |
1998 - 2005 |
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Click here for downloadable PDF > After FIELD: should fibrates be used to prevent cardiovascular disease in diabetes? |