Clinical InvestigationPrevention and RehabilitationThe role of niacin in raising high-density lipoprotein cholesterol to reduce cardiovascular events in patients with atherosclerotic cardiovascular disease and optimally treated low-density lipoprotein cholesterol: Baseline characteristics of study participants. The Atherothrombosis Intervention in Metabolic syndrome with low HDL/high triglycerides: Impact on Global Health outcomes (AIM-HIGH) trial
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Background
Atherogenic dyslipidemia is an important and increasing cause of cardiovascular risk. It is characterized by a high-risk phenotype with associated low levels of high-density lipoprotein cholesterol (HDL-C), high triglycerides, and small dense low-density lipoprotein (LDL) particles often in the setting of insulin resistance and metabolic syndrome.1 Extensive clinical trial evidence has established 3-hydroxy-3methylglutaryl coenzyme A reductase inhibitors (statins) as the backbone of preventive
Methods
AIM-HIGH is a double-blind, randomized, controlled clinical trial designed to examine the hypothesis that treatment with extended-release niacin in patients with optimally controlled LDL-C levels (40-80 mg/dL) would decrease the rate of cardiovascular events (coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, hospitalization for acute coronary syndrome or symptom-driven coronary or cerebral revascularization) in patients with a documented history of atherosclerotic
Results
Results of screening are described in the companion design manuscript. Briefly, 8,162 participants signed informed consent to be screened, 4,275 were eligible and began open-label run-in on extended-release niacin, and 3,414 were randomized.
Among the 3,569 men and 706 women enrolled into the open-label run-in, 2,910 men (82% of those enrolled) and 504 women (71% of those enrolled) were ultimately randomized to extended-release niacin or placebo. The difference between the proportions of men and
Discussion
AIM-HIGH is the first large randomized trial to evaluate the effect of niacin on cardiovascular events among statin-treated patients with established atherosclerotic cardiovascular disease who are at goal for LDL-C but who have residual abnormalities in HDL-C and triglycerides (ie, so-called atherogenic dyslipidemia). Previous studies with niacin as secondary prevention have several limitations. The Coronary Drug Project,19 the only large placebo-controlled trial of niacin monotherapy, enrolled
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Supported in part by National Institutes of Health, National Heart, Lung, and Blood Institute component grants U01 HL081616 and U01 HL081649, with additional unrestricted grant support and drug supply from Abbott Laboratories, Abbott Park, Illinois, and by drug supply from Merck, Inc, West Point, Pennsylvania.
Clinicaltrials.gov Identifier: NCT00120289.