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Odkazy a zdroje - Studie - FIELD


Fenofibrate Intervention and Event Loweringing in Diabetes

(a) The FIELD study investigators

(a) Effects of long-term fenofibrate therapy on cardiovascularevents in 9795 people with type 2 diabetes mellitus (theFIELD study): randomised controlled trial

(a) Lancet 2005;366:1849-1861

Diabetes mellitus (both primary and secondary prevention)

To test whether 5 years of fenofibrate treatment leads to a reduction in cardiovasculard disease in patient with diabetes.

Study design
Randomised, double-blind, placebo-controlled

5 years

9795 male and female patients aged 50–75 years, with type 2diabetes mellitus (2131 with previous cardiovascular disease and 7664 without), and not taking statin therapy at study entry, with a total-cholesterolconcentration of 3•0–6•5 mmol/L and a total-cholesterol/HDL-cholesterol ratio of 4•0 or more or plasma triglyceride of 1•0–5•0 mmol/L

Treatment regimen
Fenofibrate 200 mg per day, or placebo

Concomitant therapy

The primary outcome was coronary events (coronary heart disease death or non-fatal myocardial infarction); the outcome for prespecified subgroup analyses was total cardiovascular events (the composite of cardiovascular death, myocardial infarction, stroke,and coronary and carotid revascularisation). Analysis was by intention to treat. The study was prospectively registered (number ISRCTN 64783481).
Vital status was confirmed on all but 22 patients. Averaged over the 5 years’ study duration, similar proportions in each group discontinued study medication (10% placebo vs 11% fenofibrate) and more patients allocated placebo(17%) than fenofibrate (8%; p<0.0001) commenced other lipid treatments, predominantly statins. 5.9% (n=288) ofpatients on placebo and 5•2% (n=256) of those on fenofibrate had a coronary event (relative reduction of 11%; hazardratio [HR] 0.89, 95% CI 0.75–1.05; p=0.16). This finding corresponds to a significant 24% reduction in non-fatal myocardial infarction (0.76, 0.62–0.94; p=0.010) and a non-significant increase in coronary heart disease mortality (1•19, 0•90–1•57; p=0•22). Total cardiovascular disease events were significantly reduced from 13.9% to 12.5% (0.89,0.80–0.99; p=0.035). This finding included a 21% reduction in coronary revascularisation (0.79, 0.68–0.93; p=0.003).Total mortality was 6.6% in the placebo group and 7.3% in the fenofibrate group (p=0.18). Fenofibrate was associated with less albuminuria progression (p=0.002), and less retinopathy needing laser treatment (5.2% vs 3.6%, p=0.0003). There was a slight increase in pancreatitis (0.5% vs 0.8%, p=0•031) and pulmonary embolism (0.7% vs 1.1%,p=0.022), but no other significant adverse effects.
Conclusions: Fenofibrate did not significantly reduce the risk of the primary outcome of coronary events. It did reducetotal cardiovascular events, mainly due to fewer non-fatal myocardial infarctions and revascularisations. The higher rateof starting statin therapy in patients allocated placebo might have masked a moderately larger treatment benefit.