Diabetes trial provides guidance for coronary care

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World's largest type 2 diabetes intervention trial provides guidance for cardiovascular disease prevention

Dallas, USA – 14th November 2005: Results of the largest intervention study to assess the risk of cardiovascular disease events in people with type 2 diabetes show that heart attacks and coronary interventions (such as bypass surgery) can be reduced with fenofibrate – a well-established agent for modifying blood fats (lipids).

However, fenofibrate was not associated with a significant reduction in the study's primary outcome of major coronary events (heart attack or coronary death).

The results of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study were presented at the Scientific Sessions of the American Heart Association today and published on-line in The Lancet.

It was conducted by the National Health and Medical Research Council Clinical Trials Centre at the University of Sydney, Australia, and involved centres in Australia, New Zealand and Finland. It involved nearly 10,000 patients recruited from 63 sites and studied over an average of five years.

FIELD recruited men and women with type 2 diabetes commonly seen in daily practice. There were 78% without prior cardiovascular disease (CVD) history (the primary prevention group) and the remainder had at least one manifestation of CVD.

Key findings
Overall, fenofibrate was associated with 11% fewer major coronary events (heart attack or coronary death), but this reduction was not statistically significant (p=0.16). This was the primary endpoint of the study.

Treatment with fenofibrate significantly reduced the risk of CVD (cardiovascular death, heart attack, stroke, coronary and carotid revascularisation) by 11% (p=0.035), due mainly to a 24% (p=0.01) reduction in the risk of non-fatal heart attack and a 21% (p=0.003) reduction in the need for coronary angioplasty or bypass surgery.

The effects of treatment were seen predominantly among patients in the primary prevention group where fenofibrate reduced the risk of total cardiovascular events by 19% (p=0.004).
Commenting on the results, principal investigator Professor Anthony Keech, said: "FIELD was a large and scientifically rigorous study.

"It showed that, in patients with type 2 diabetes, treatment with fenofibrate does reduce the risk of coronary events such as heart attack and the need for coronary procedures, especially in those without known cardiovascular disease."

The trial protocol allowed treating physicians to commence non-study lipid lowering therapy (predominantly statins) during the course of the study. There was a higher rate of initiating statin therapy among patients allocated placebo (average 17%) than allocated fenofibrate (average 8%). This may have masked a moderately larger treatment benefit of fenofibrate.

Fenofibrate was well tolerated with similar proportions of patients remaining on therapy (fenofibrate = 81.6%, placebo = 81.5%) for the duration of the five year study.

There were more coronary deaths and fewer other vascular deaths in the fenofibrate group, neither being statistically significant (both p>0.2). There was also a non-significant increase in total mortality that was not linked to any particular cause and was consistent with statistical chance.

Microvascular benefits
FIELD is the first study to suggest that fenofibrate reduces both diabetes-related kidney and eye disease.

There were beneficial effects of fenofibrate on urinary albumin excretion (a marker of renal disease) (p<0.002) and the need for laser treatment of eye disease was reduced by 30% (p=0.0003).

Interpretation
Professor Keech said that while the results of the FIELD study were mixed, they will guide clinicians on the use of fenofibrate in the management of people with type 2 diabetes.

"In the context of the well established benefits of statin therapy in this patient group, the main use of fenofibrate will probably be in combination therapy. This question needs to be considered in future studies.

"Fenofibrate was well tolerated alone and in combination. It achieved reductions in non-fatal macrovascular events, especially in primary prevention, and reduced microvascular complications," Professor Keech said.

ENDS

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