Patients receiving statin therapy for high cholesterol who additionally received a combination of extended-release niacin and laropiprant, saw reductions in their HDL, but saw no difference in the rate of major vascular events. The test group, in fact, experienced a higher rate of adverse events and complications when compared to patients taking a placebo.
The troubling findings, published in the New England Journal of Medicine, add to a body of evidence showing no beneficial effect of niacin, but reveals concerning new information about risks.
Of the 25,000 patients studied, the rate of major vascular events between the test and placebo groups remained nearly the same (13.2 percent and 13.7 percent, respectively). Serious adverse events, however, were more evident in the test group (55.6 percent versus 52.7). Those events included serious complications related to diabetes, infection, bleeding, gastrointestinal issues, and skin-related problems.
A separate editorial commentary in the NEJM urged caution in the usage of niacin for cholesterol, considering previous research findings and the most recent evidence of potential harm.