ER niacin bests ezetimibe on measure of atherosclerosis

Key Points

Extended-release (ER) niacin proved better than ezetimibe in favorably changing carotid intima-media thickness (CIMT), a measure of atherosclerosis, in high-risk patients who were already receiving a statin, said Allen J. Taylor, MD, at the 2009 scientific sessions of the American Heart Association in Orlando, Fla.

In a study comparing the 2 agents, patients randomly assigned to ER niacin, 2 g/day, achieved a .014 mm regression in CIMT, whereas those assigned to ezetimibe had no evidence of disease regression (P≤.001), said Dr Taylor, a cardiologist at Walter Reed Army Medical Center in Washington, D.C. Paradoxically, those in the ezetimibe group who had the greatest decrease in level of low-density lipoprotein (LDL) cholesterol had increases in CIMT.

A post-hoc analysis showed that although patients in the ezetimibe arm had a significant reduction in LDL cholesterol of an average of 19.2%, to an average of 66 mg/dL, the "greater reductions in LDL cholesterol level in association with ezetimibe were significantly associated with an increase in carotid intima-media thickness," according to Dr Taylor.

Although the study was not powered to detect a difference in the rate of clinical endpoints, the rate of major adverse cardiac events (myocardial infarction, revascularization, cardiovascular death, and hospitalizations for acute coronary syndrome) was significantly lower in the ER niacin arm compared to the ezetimibe arm (1.2% vs 5.5%, respectively; P=.04).

Reliance on a surrogate endpoint such as CIMT to make clinical decisions was a topic of debate, with some experts in cardiovascular medicine saying they preferred data on hard endpoints before reaching a conclusion about the utility of treatments.