The use of extended-release (ER) niacin as an adjunct to statins does not reduce the risk of a heart attack or stroke in patients with pre-existing cardiovascular disease, according to researchers who led the HPS2-THRIVE study. The results of the study were reported March 9 at the American College of Cardiology conference in San Francisco.
Researchers also found that ER niacin caused significant side effects that were serious, including some that were unexpected-infections, bleeding in the stomach and brain, and an increased risk of myopathy, according to a press statement.
More than 25,000 patients from the United Kingdom, Scandinavia, and China were recruited for HPS2-THRIVE. All received simvastatin and when required, another cholesterol-lowering drug, ezetimibe. They were randomized to receive either ER niacin with laropiprant in addition to the statin therapy or placebo for 4 years.
Approximately 13.2% of patients who took the ER niacin/laropiprant combination had a heart attack, stroke, or arterial procedure compared with 13.7% of patients in the placebo group. The results were similar to the AIM-HIGH trial of ER niacin alone in 3,400 high-risk patients. That study was stopped early after 3 years because of no beneficial effects. Similar side effects that are known with niacin occurred in patients during the AIM-HIGH study.
“The use of niacin for the prevention of cardiovascular events should now be reconsidered,” said Jane Armitage, the principal investigator and professor at Oxford University’s Clinical Trial Service Unit. “The HPS2-THRIVE trial shows that niacin causes significant hazards and does not reduce the number of people suffering heart attacks and strokes when added to treatments, such as cholesterol-lowering statin therapy, which are known to be safe and effective.”
HPS2-THRIVE was funded by a grant to Oxford University from Merck & Co., which supplied the ER niacin/laropiprant and matching placebo medications, as well as the statin therapy.
Merck said in late December 2012 that it did not plan to take the drug before the FDA to gain approval when the failure of niacin in the HPS2-THRIVE study was first announced.