Cardiovascular outcome trial · N Engl J Med 2010
ACCORD Lipid trial
Effects of combination lipid therapy in type 2 diabetes mellitus.
The bottom line
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.
No significant benefitUS status: US-approved
At a glance
- Medicine
- Fenofibrate (masked) added to open-label simvastatin
- Compared with
- Placebo added to open-label simvastatin
- People
- 5,518
- Who took part
- Patients with type 2 diabetes mellitus at high risk for cardiovascular disease, treated with open-label simvastatin
- Design
- randomized, open-label simvastatin background with masked fenofibrate vs placebo
- Follow-up
- mean 4.7 years
- Main question
- First occurrence of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes
Main result
The annual rate of the primary outcome was 2.2% in the fenofibrate group and 2.4% in the placebo group (hazard ratio in the fenofibrate group, 0.92; 95% confidence interval [CI], 0.79 to 1.08; P=0.32)
Other results
Annual rates of death were 1.5% in the fenofibrate group and 1.6% in the placebo group (hazard ratio, 0.91; 95% CI, 0.75 to 1.10; P=0.33)
In the trial's own words
“The annual rate of the primary outcome was 2.2% in the fenofibrate group and 2.4% in the placebo group (hazard ratio in the fenofibrate group, 0.92; 95% confidence interval [CI], 0.79 to 1.08; P=0.32).”
Quoted from the abstract of N Engl J Med 2010, checked word for word against PubMed. PubMed 20228404 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Fibrates (fenofibrate)
Common questions
What did the ACCORD Lipid trial find?
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.
Who was in ACCORD Lipid?
5,518 people. Patients with type 2 diabetes mellitus at high risk for cardiovascular disease, treated with open-label simvastatin.
What was ACCORD Lipid's main result?
The annual rate of the primary outcome was 2.2% in the fenofibrate group and 2.4% in the placebo group (hazard ratio in the fenofibrate group, 0.92; 95% confidence interval [CI], 0.79 to 1.08; P=0.32)
Related trials
- 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.
- 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.
- HPS2-THRIVE (2014)Adding extended-release niacin-laropiprant to statin therapy in patients with vascular disease did not reduce major vascular events and increased serious adverse effects, including new-onset diabetes, infection, and bleeding.
- FIELD (2005)In patients with type 2 diabetes not on statins, fenofibrate did not significantly reduce coronary events but did reduce total cardiovascular events, driven by fewer nonfatal heart attacks and revascularizations, with a small increase in pancreatitis and pulmonary embolism.
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