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Fenofibrate Intervention and Event Lowering in Diabetes

FIELD. Fenofibrate Intervention and Event Lowering in Diabetes. Presented at The American Heart Association Scientific Sessions, November 2005 Presented by Dr. Anthony Keech. FIELD: Background.

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Fenofibrate Intervention and Event Lowering in Diabetes

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  1. FIELD Fenofibrate Intervention and Event Lowering in Diabetes Presented at The American Heart Association Scientific Sessions, November 2005 Presented by Dr. Anthony Keech

  2. FIELD: Background • Statins, whose main action is to lower LDL, have been shown to have significant beneficial effects in diabetics • Fibrates affect different components of the lipid profile by preferentially increasing HDL, lowering triglycerides, and increasing the size of LDL particles • Fibrates could be beneficial for diabetics in whom low HDL, high triglycerides, and small LDL particles are more common than in the general population • The goal of the study is to evaluate treatment with fenofibrate compared with placebo in patients with diabetes who are at risk for coronary heart disease ● AHA 2005

  3. FIELD: Design 9795 patients, Age 50-75 years, type 2 diabetes diagnosed after age 35 years, no clear indication for cholesterol-lowering therapy at baseline (total cholesterol 116-251 mg/dL, plus either total cholesterol to HDL ratio ≥4.0 or triglyceride >88.6 mg/dL Fenofibrate (200 mg daily) n=4895 Placebo N=4900 • Endpoints: • Primary – Composite of CHD death or non-fatal MI at 5 year follow-up • Secondary – Composite of total CV events, CV mortality, total mortality, stroke, coronary revascularization and all revascularization at 5 year follow-up ESC 2005

  4. FIELD: Primary Endpoint Composite CHD death or nonfatal MI at 5 Years (% of treatment arm) • The primary composite endpoint of CHD death or non-fatal MI was not significantly lower in the fenofibrate group compared to the placebo group. p=0.16 AHA 2005

  5. FIELD: Primary Endpoint CHD death or nonfatal MI at 5 year follow-up (% of treatment arm) P=0.01 • CHD death was not significantly different between treatment groups • Nonfatal MI was significantly lower in the fenofibrate group compared with the placebo group. P=0.22 AHA 2005

  6. FIELD: Secondary Endpoint Secondary Composite Endpoint of Total CV events at 5 year Follow-up • The secondary composite endpoint of total CV events was significantly lower in the fenofibrate group compared to the placebo group (% of treatment arm) p=0.035 AHA 2005

  7. FIELD: Secondary Endpoint Individual Components of Secondary Endpoint p=0.18 • CV Mortality, Total Mortality, and Stroke were not significantly different between the fenofibrate and placebo groups p=0.36 p=0.41 AHA 2005

  8. FIELD: Secondary Endpoint Individual Components of Secondary Endpoint P=0.001 P=0.003 • Percentage of coronary revascularization and all revascularization were significantly lower in the fenofibrate group compared to placebo AHA 2005

  9. FIELD: Limitations • The results of this study may have been confounded by uneven use of statins between the two groups as 17% of the placebo group was prescribed a statin during the trial compared with 7% in the fenofibrate group • Although adjusting for statin use yields a statistically significant reduction in the primary endpoint (19%, p=0.01) this may slightly overestimate the effect for the fenofibrate group since the use of statins was not randomized • In terms of adverse effects, the fenofibrate group showed small increases in pancreatitis (0.5% vs 0.8%, p=0.031) and pulmonary embolism (0.7% vs 1.1%, p=0.022) • Although fenofibrate reduced triglycerides and LDL, there was virtually no increase shown in HDL AHA 2005

  10. FIELD: Summary • Among patients with diabetes at risk of coronary heart disease, there was no statistically significant difference in the primary composite endpoint of CHD death or nonfatal MI. There was, however, a significant reduction in nonfatal MI in the fenofibrate group compared with placebo. • The secondary composite endpoint of total cardiovascular events was significantly lower in the fenofibrate group primarily due to reductions in nonfatal MI and revascularizations. • The results may have been confounded by a difference in statin use between the two groups as 17% of the placebo group were prescribed statins during the trial compared to 7% in the fenofibrate group. This may have attenuated treatment effect differences. • The ACCORD trial, which will randomize diabetics to either fenofibrate or placebo with all patients taking simvastatin, will provide a more definitive answer regarding the benefit of fenofibrates in diabetics. AHA 2005

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