Recent studies published in The New England Journal of Medicine are adding to concerns about the safety and effectiveness of niacin, which is used for the prevention of cardiovascular disease.
According to a report in the New York Times, scientists designed these two new studies to determine whether niacin helped patients avoid heart disease and stroke in the statin era. The National Institutes of Health sponsored an American study, and the drug company Merck funded a large international study. One tested extended-release niacin, and the other evaluated a combination of extended-release niacin and laropiprant, an agent designed to make the niacin more tolerable.
Both studies failed to show that niacin reduced the risks of heart disease, stroke and death. Researchers stopped the American study prematurely because the possibility of finding any benefit became so remote that its continuation seemed futile. Additional follow-up analyses conducted in both studies did not show that niacin provided a convincing benefit to any group of patients.
In addition, researchers found niacin causes multiple side effects, many of which are serious.
Critiques have indicated that the trials focused on high-risk patients, almost all of whom were taking statins and had low levels of LDL cholesterol. They ask whether niacin might be useful in patients with different lipid profiles, or in those who cannot tolerate statins or who had not already had a diagnosis of heart disease, or in patients with an even higher risk of heart disease and stroke.
According to the news report, those taking niacin should talk with their doctor about whether they should continue.