| Abstract
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BACKGROUND: The aim of this study was to test the hypothesis that
patients with atherosclerotic cardiovascular (CV) disease optimally
treated on a statin but with residual atherogenic dyslipidemia
(low high-density lipoprotein cholesterol [HDL-C] and high triglycerides)
will benefit from addition of niacin with fewer CV events compared
with placebo. Statin monotherapy trials have found 25%-35% CV
risk reduction relative to placebo, leaving significant residual
risk. Patients with atherogenic dyslipidemia have substantially
increased CV risk.
METHODS: Participants were men and women with established CV disease
and atherogenic dyslipidemia. Lipid entry criteria varied by gender
and statin dose at screening. All participants received simvastatin
(or simvastatin plus ezetimibe) at a dose sufficient to maintain
low-density lipoprotein cholesterol (LDL-C) 40-80 mg/dL (1.03-2.07
mmol/L). Participants were randomized to extended-release niacin
or matching placebo. The primary end point was time to occurrence
of the first of the following: coronary heart disease death, nonfatal
myocardial infarction, ischemic stroke, hospitalization for acute
coronary syndrome, or symptom-driven coronary or cerebral revascularization.
This event-driven trial will have 85% power to show a 25% reduction
in primary event frequency after 850 patients have experienced
a primary outcome event.
RESULTS: AIM-HIGH completed enrollment in April 2010. Follow-up
is expected to continue through 2012.
SUMMARY: AIM-HIGH was designed to determine whether treating residual
dyslipidemia with niacin further reduces cardiovascular events
in patients with CV disease on a statin at target levels of low-density
lipoprotein cholesterol.
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