Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy

Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy

DECEMBER 15, 2011 | The AIM-HIGH Investigators*
The AIM-HIGH trial aimed to determine whether adding extended-release niacin to intensive statin therapy would reduce cardiovascular events in patients with established atherosclerotic cardiovascular disease and low HDL cholesterol levels. Patients were randomly assigned to receive either niacin (1500-2000 mg/day) or placebo, in addition to simvastatin (40-80 mg/day) and ezetimibe (10 mg/day) if needed to maintain LDL cholesterol levels between 40-80 mg/dL. The primary endpoint was a composite of major cardiovascular events. After a mean follow-up of 3 years, the trial was stopped due to lack of efficacy. At 2 years, niacin therapy significantly increased HDL cholesterol levels and decreased triglyceride levels but did not reduce the primary endpoint. The hazard ratio for the primary endpoint was 1.02 (95% CI 0.87-1.21) in the niacin group compared to the placebo group. The unexpected higher rate of ischemic stroke in the niacin group was noted, but no causal association was established. The study concluded that extended-release niacin added to intensive statin therapy did not provide incremental clinical benefit in reducing cardiovascular events in patients with established cardiovascular disease and low HDL cholesterol levels.The AIM-HIGH trial aimed to determine whether adding extended-release niacin to intensive statin therapy would reduce cardiovascular events in patients with established atherosclerotic cardiovascular disease and low HDL cholesterol levels. Patients were randomly assigned to receive either niacin (1500-2000 mg/day) or placebo, in addition to simvastatin (40-80 mg/day) and ezetimibe (10 mg/day) if needed to maintain LDL cholesterol levels between 40-80 mg/dL. The primary endpoint was a composite of major cardiovascular events. After a mean follow-up of 3 years, the trial was stopped due to lack of efficacy. At 2 years, niacin therapy significantly increased HDL cholesterol levels and decreased triglyceride levels but did not reduce the primary endpoint. The hazard ratio for the primary endpoint was 1.02 (95% CI 0.87-1.21) in the niacin group compared to the placebo group. The unexpected higher rate of ischemic stroke in the niacin group was noted, but no causal association was established. The study concluded that extended-release niacin added to intensive statin therapy did not provide incremental clinical benefit in reducing cardiovascular events in patients with established cardiovascular disease and low HDL cholesterol levels.
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