Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial.
Abstract | BACKGROUND: METHODS: FINDINGS: 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) of patients on placebo and 5.2% (n=256) of those on fenofibrate had a coronary event (relative reduction of 11%; hazard ratio [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. INTERPRETATION:
Fenofibrate did not significantly reduce the risk of the primary outcome of coronary events. It did reduce total cardiovascular events, mainly due to fewer non-fatal myocardial infarctions and revascularisations. The higher rate of starting statin therapy in patients allocated placebo might have masked a moderately larger treatment benefit.
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Authors | A Keech, R J Simes, P Barter, J Best, R Scott, M R Taskinen, P Forder, A Pillai, T Davis, P Glasziou, P Drury, Y A Kesäniemi, D Sullivan, D Hunt, P Colman, M d'Emden, M Whiting, C Ehnholm, M Laakso, FIELD study investigators |
Journal | Lancet (London, England)
(Lancet)
Vol. 366
Issue 9500
Pg. 1849-61
(Nov 26 2005)
ISSN: 1474-547X [Electronic] England |
PMID | 16310551
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Hypolipidemic Agents
- Triglycerides
- Cholesterol
- Fenofibrate
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Topics |
- Aged
- Cardiovascular Diseases
(etiology, prevention & control)
- Cholesterol
(blood)
- Coronary Disease
(mortality, prevention & control)
- Diabetes Mellitus, Type 2
(blood, complications)
- Double-Blind Method
- Dyslipidemias
(complications, drug therapy)
- Female
- Fenofibrate
(adverse effects, therapeutic use)
- Humans
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
(therapeutic use)
- Hypolipidemic Agents
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Triglycerides
(blood)
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