Cardiovascular outcome trial · N Engl J Med 2011
AIM-HIGH trial
Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy.
The bottom line
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.
No significant benefitUS status: US-approved
At a glance
- Medicine
- Extended-release niacin, 1500 to 2000 mg per day, plus simvastatin, 40 to 80 mg per day, plus ezetimibe, 10 mg per day, if needed
- Compared with
- Matching placebo plus simvastatin, 40 to 80 mg per day, plus ezetimibe, 10 mg per day, if needed
- People
- 3,414
- Who took part
- Patients with established cardiovascular disease and low HDL cholesterol levels receiving intensive statin therapy, with atherosclerotic cardiovascular disease and LDL cholesterol levels of less than 70 mg per deciliter
- Design
- randomized, placebo-controlled (stopped early for lack of efficacy)
- Follow-up
- mean follow-up period of 3 years (36-month follow-up period)
- Main question
- First event of the composite of death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome, or symptom-driven coronary or cerebral revascularization
Main result
The primary end point occurred in 282 patients in the niacin group (16.4%) and in 274 patients in the placebo group (16.2%) (hazard ratio, 1.02; 95% confidence interval, 0.87 to 1.21; P=0.79 by the log-rank test).
Effect on LDL cholesterol
Lowered the LDL cholesterol level from 74 mg per deciliter (1.91 mmol per liter) to 62 mg per deciliter (1.60 mmol per liter); also increased median HDL cholesterol from 35 mg per deciliter (0.91 mmol per liter) to 42 mg per deciliter (1.08 mmol per liter) and lowered triglyceride level from 164 mg per deciliter (1.85 mmol per liter) to 122 mg per deciliter (1.38 mmol per liter)
Other results
No incremental clinical benefit from the addition of niacin to statin therapy during a 36-month follow-up period, despite significant improvements in HDL cholesterol and triglyceride levels.
Safety
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In the trial's own words
“The primary end point occurred in 282 patients in the niacin group (16.4%) and in 274 patients in the placebo group (16.2%) (hazard ratio, 1.02; 95% confidence interval, 0.87 to 1.21; P=0.79 by the log-rank test).”
Quoted from the abstract of N Engl J Med 2011, checked word for word against PubMed. PubMed 22085343 · Full paper (DOI)
Common questions
What did the AIM-HIGH trial find?
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.
Who was in AIM-HIGH?
3,414 people. Patients with established cardiovascular disease and low HDL cholesterol levels receiving intensive statin therapy, with atherosclerotic cardiovascular disease and LDL cholesterol levels of less than 70 mg per deciliter.
What was AIM-HIGH's main result?
The primary end point occurred in 282 patients in the niacin group (16.4%) and in 274 patients in the placebo group (16.2%) (hazard ratio, 1.02; 95% confidence interval, 0.87 to 1.21; P=0.79 by the log-rank test).
How much did LDL cholesterol change in AIM-HIGH?
Lowered the LDL cholesterol level from 74 mg per deciliter (1.91 mmol per liter) to 62 mg per deciliter (1.60 mmol per liter); also increased median HDL cholesterol from 35 mg per deciliter (0.91 mmol per liter) to 42 mg per deciliter (1.08 mmol per liter) and lowered triglyceride level from 164 mg per deciliter (1.85 mmol per liter) to 122 mg per deciliter (1.38 mmol per liter)
Related trials
- 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.
- 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.
- 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.
- 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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