AIM-HIGH Trial

Trial Details

Acronym: Atherothrombosis Intervention in Metabolic Syndrome with low HDL/HIGH Triglycerides trial

Purpose: Evaluated niacin versus placebo in patients with documented vascular disease and HDL levels < 42 for men and < 53 for women

Format: Randomized, placebo controlled,

Treatment Group: Niacin, 1500 to 2000 mg per day

Control Group: Placebo

Number of Patients: 3,414

Inclusion Criteria:

• 45 years of age or older and had
• Established cardiovascular disease
• Low baseline levels of HDL cholesterol (<40 mg/dL for men; <50 mg/dLfor women
• Elevated triglyceride levels
• LDL cholesterol levels lower than 180 mg per deciliter

Exclusion Criteria:

• hospitalized for an acute coronary syndrome within 4 weeks before enrollment or
• had undergone a planned revascularization procedure
• had a stroke within the preceding 8 weeks

Primary Endpoint: First event of composite cardiovascular death, nonfatal MI, ischemic stroke, hospitalization for acute coronary syndrome or symptom driven coronary/cerebral revascularization

Secondary Endpoints:

• Death from coronary heart disease
• Nonfatal myocardial infarction
• Ischemic stroke
• Hospitalization for a “high-risk” acute coronary syndrome
• Death from cardiovascular causes

Follow-up: Mean, 3 years

Summary:

Niacin did not reduce the primary endpoint of composite cardiovascular death, nonfatal MI, ischemic stroke, hospitalization for acute coronary syndrome or symptom driven coronary/cerebral revascularization. The HDL levels and triglyceride levels did improve.

Original Publication:

Boden WE, et al. N Engl J Med. 2011;doi:10.1056/NEJMoa1107579.