FIELD trial

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)

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Total cardiovascular disease events were significantly reduced from 13.9% to 12.5% (0.89, 0.80-0.99; p=0.035), including a 21% reduction in coronary revascularisation (0.79, 0.68-0.93; p=0.003); non-fatal MI reduced 24% (0.76, 0.62-0.94; p=0.010); CHD mortality non-significantly increased (1.19, 0.90-1.57; p=0.22); total mortality 6.6% placebo vs 7.3% fenofibrate (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.

“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).”

Quoted from the abstract of Lancet 2005, checked word for word against PubMed. PubMed 16310551 · Full paper (DOI)

• JELIS (2007)Adding EPA to statin therapy modestly reduced major coronary events, mainly non-fatal events, in hypercholesterolaemic Japanese patients, without a significant effect on sudden cardiac or coronary death.
• ACCORD Lipid (2010)Adding fenofibrate to simvastatin did not reduce cardiovascular events or death compared with simvastatin alone in high-risk patients with type 2 diabetes, so routine combination therapy is not supported.
• VA-HIT (1999)In men with coronary heart disease and low HDL cholesterol but not high LDL, gemfibrozil reduced the risk of major cardiovascular events despite not lowering LDL cholesterol.
• AIM-HIGH (2011)In statin-treated patients with established cardiovascular disease and already-low LDL, adding extended-release niacin raised HDL and lowered triglycerides but did not reduce cardiovascular events compared with placebo.