Niacin for patients with low HDL receiving intensive statin therapy

January 01, 0001

Niacin for patients with low HDL receiving intensive statin therapy

In patients with established cardiovascular disease, residual cardiovascular risk persists despite the achievement of target low-density lipoprotein (LDL) cholesterol levels with statin therapy. These US And Canadian investigators randomly assigned eligible patients to receive extended- release niacin, 1500 to 2000 mg per day, or matching placebo. All patients received simvastatin, 40 to 80 mg per day, plus ezetimibe, 10 mg per day, if needed, to maintain an LDL cholesterol level of 40 to 80 mg per deciliter (1.03 to 2.07 mmol per liter). The primary end point was the first event of the composite of death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome, or symptom-driven coronary or cerebral revascularization.

They found: "A total of 3414 patients were randomly assigned to receive niacin (1718) or placebo (1696). The trial was stopped after a mean follow-up period of 3 years owing to a lack of efficacy. At 2 years, niacin therapy had significantly increased the median HDL cholesterol level from 35 mg per deciliter (0.91 mmol per liter) to 42 mg per deciliter (1.08 mmol per liter), lowered the triglyceride level from 164 mg per deciliter (1.85 mmol per liter) to 122 mg per deciliter (1.38 mmol per liter), and lowered the LDL cholesterol level from 74 mg per deciliter (1.91 mmol per liter) to 62 mg per deciliter (1.60 mmol per liter). The primary end point occurred in 282 patients in the niacin group (16.4%) and in 274 patients in the placebo group (16.2%)."

The authors concluded: "Among patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of less than 70 mg per deciliter (1.81 mmol per liter), there was no incremental clinical benefit from the addition of niacin to statin therapy during a 36-month follow-up period, despite significant improvements in HDL cholesterol and triglyceride levels."

This study highlights the importance of evaluating effectiveness based on outcomes that people care about rather than relying on surrogate endpoints.

For the full abstract, click here.

N Engl J Med published online 14 November 2011 © 2011 to the Massachusetts Medical Society
Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy. The AIM-HIGH Investigators. Correspondence to Ms. Ruth McBride: ruthm@axioresearch.com

Category: T. Endocrine/Metabolic/Nutritional, K. Circulatory. Keywords: cardiovascular disease, cholesterol, niacin, simvastatin, ezetibe, secondary prevention, randomized controlled trial, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 6 December 2011

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.