Abstract
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OBJECTIVES: The study aims to report the baseline characteristics
of the fully randomized AIM-HIGH study population.
BACKGROUND: Residual risk persists despite aggressive low-density
lipoprotein cholesterol (LDL-C) reduction in patients with atherosclerotic
cardiovascular (CV) disease, many of whom have atherogenic dyslipidemia
(low levels of high-density lipoprotein cholesterol (HDL-C), elevated
triglycerides, and small dense LDL particles).
METHODS: All study participants had established CV disease and
atherogenic dyslipidemia. Participants received simvastatin (or
simvastatin plus ezetimibe) at a dose sufficient to maintain LDL-C
at 40 - 80 mg/dL (1.03-2.07 mmol/L) and were randomized to receive
extended-release niacin or matching placebo. The primary end point
is time to the first occurrence of coronary heart disease death,
nonfatal myocardial infarction, ischemic stroke, hospitalization
for acute coronary syndrome or symptom-driven coronary or cerebral
revascularization with average follow-up of 4.1 years.
RESULTS: Between 2006 and 2010, 8,162 individuals signed consent
to be screened, 4,275 began study drug run-in, and 3,414 were
randomized to treatment. Mean age at entry was 64 ± 9 years,
85% were men, and 92% were white. As expected, risk factors were
prevalent with 34% having diabetes; 71%, hypertension; and 81%,
metabolic syndrome. Most participants had coronary artery disease
(92%), whereas 11% had peripheral arterial disease; and 12%, cerebrovascular
disease. Previous coronary revascularization occurred in 82%,
and 54% reported a prior myocardial infarction. Among participants
on a statin at entry (94%), mean baseline LDL-C was 71 mg/dL (1.84
mmol/L); mean HDL-C, 34.9 mg/dL (0.90 mmol/L); and median triglycerides,
161 mg/dL (1.82 mmol/L).
SUMMARY: AIM-HIGH enrolled a high-risk group of patients with
established atherosclerotic CV disease and atherogenic dyslipidemia.
This study should determine whether there is incremental clinical
benefit of niacin in reducing cardiovascular events in patients
who have attained optimal on-treatment levels of LDL-C with a
statin.
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