2005 AHA Scientific Sessions: FIELD trial

The American Heart Association (AHA) Scientific Sessions comprise the world's largest conference for scientists and healthcare professionals focusing on cardiovascular disease. The 2005 AHA Scientific Sessions, which took place in Dallas, Texas, featured 4 days of invited lectures and investigative reports. The conference included presentations of trials that evaluated investigational therapeutic agents, as well as approved agents in alternative regimens or for alternative indications.

Fenofibrate significantly reduced the risk of total cardiovascular events in patients with type 2 diabetes but had no significant effect on the incidence of total coronary events, according to Anthony Keech, MD, lead investigator of the FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) trial. The incidence of total coronary events was the primary end point in the trial, while the incidence of total cardiovascular events was the secondary end point.

FIELD included 9,795 patients with type 2 diabetes with well-controlled glucose levels who were randomized to once-daily treatment with micronized fenofibrate 200 mg or placebo for 5 to 7 years. None of the patients enrolled had a clear indication for lipid-modifying therapy and more than three-fourths (78%) had no history of cardiovascular disease.

Other secondary end points favored the use of fenofibrate, including an 11% reduction in total cardiovascular events (cardiovascular death, heart attack, stroke, coronary and carotid revascularization) (P=.035), a 21% reduction in coronary revascularization (P=.003), and reductions in microvascular end points such as progression to albuminuria (P<.002) and the need for laser treatment for retinopathy (P=.0003).

The confirmed beneficial effects on microvascular disease set this agent apart from the statins, Dr Keech said. FIELD is the first large-scale clinical study to demonstrate that a lipid-modifying agent can reduce the risk of macrovascular and microvascular events in patients with type 2 diabetes.

The favorable effects of fenofibrate were observed predominantly among patients in the primary prevention group, in whom fenofibrate reduced the risk of total cardiovascular events by 19% (P<.004).

"We found a clear signal of benefit in the primary prevention group, which constituted 78% of the study group," Dr Keech said. "In the secondary prevention group, post-MI population, we didn't have good evidence but of course this was a much smaller subgroup. There was borderline significance statistically in the right direction between the two."

The reduced risks did not translate into an improvement in survival: 7.3% of the fenofibrate group and 6.6% of the placebo group died, a nonsignificant difference.

Based on the results of the double-blind, randomized, placebo-controlled study, the best use for fenofibrate in the management of patients with type 2 diabetes will probably be in combination with a statin, according to Dr Keech. "This question needs to be considered in future studies," he said.

About 84% of the patients met the criteria for metabolic syndrome, and the effects of fenofibrate were comparable in both those with and without metabolic syndrome. "Similarly, 52% of the patients had high triglyceride levels (>150 mg/dL), and again the effects of fenofibrate were very similar in those with and without the high triglyceride levels," Dr Keech said.