For patients with preexisting occlusive vascular disease, the combination of niacin and the anti-flushing agent laropiprant provides no benefit and is associated with an increase in serious side effects, according to a study presented at the annual meeting of the American College of Cardiology in San Francisco.
Jane M. Armitage, MBBS, from the University of Oxford in the United Kingdom, and colleagues randomized 25,673 patients with preexisting occlusive vascular disease at 245 hospitals in six countries to receive daily active extended release (ER) niacin/laropiprant or placebo in addition to background low-density lipoprotein-lowering therapy.
Over four years of follow-up, the researchers found that the number of major vascular events (defined as a composite of non-fatal myocardial infarction or coronary death, any stroke, or any arterial revascularization) was similar for patients receiving ER niacin/laropiprant or placebo (13.2% vs. 13.7%). Patients treated with ER niacin/laropiprant had a significant excess of bleeding (2.5% vs. 1.9%) and infections (8.0% vs. 6.6%). Other serious side effects were significantly increased among the ER niacin/laropiprant-treated patients, including new-onset diabetes, diabetic complications, gastrointestinal problems such as indigestion and diarrhea, and skin issues such as itching and rashes.
“We are disappointed that these results did not show benefits for our patients,” Armitage said in a statement. “Still, finding out a drug is not helping people is just as important as finding that it has benefits — the net result is that people are healthier. Niacin has been used for many years in the belief that it would help patients and prevent heart attacks and stroke, but we now know that its adverse side effects outweigh the benefits when used with current treatments.”