Niacin Time Release reduces blood fats and significantly reverses the thickening of carotid artery walls in patients with heart disease
Researchers from Walter Reed Army Medical Center in Washington , DC , and the Washington Adventist Hospital in Takoma Park , Maryland enrolled a range off patients into the study who were at risk of developing a heart attack or stroke. 279 of the patients had known atherosclerotic coronary artery disease and 38 patients were at major risk of developing atherosclerotic coronary artery disease because they had major risk factors such as diabetes, 26 patients had moderate risk of developing it, and 20 patients who were included had moderate evidence of coronary artery disease found through a cardiac ct scan. All patients were on statin drug therapy to reduce their cholesterol and all had an LDL-level under 100 and an HDL of over 50 for men and 55 for women.
The patients were randomly assigned to receive extended-release niacin (target dose, 2000 mg per day) or ezetimibe (10 mg per day) also known as Zetia. The researchers were testing to see if either Niacin or ezetimibe, if added to their existing medicine could reverse the thickening of the common carotid intimamedia thickness after 14 months; this would reduce the risk of stroke. The trial was terminated early, on the basis of efficacy, according to a prespecified analysis conducted after 208 patients had completed the trial.
At the end of the study mean HDL cholesterol in the niacin group increased by a whopping 18.4% over the 14-month study period, to 50 mg per deciliter and it significantly reduced both LDL-cholesterol and triglycerides. The mean LDL cholesterol level in the ezetimibe group decreased by 19.2%, to 66 mg per deciliter (1.7 mmol per liter) and it also modestly reduced triglycerides but it unfortunately also reduced HDL.
Niacin therapy significantly reduced the mean carotid artery intimamedia thickness over 14 months but unfortunately ezetimibe was significantly connected to further thickening of the carotid arteries lining. The incidence of major cardiovascular events was lower in the niacin group than in the ezetimibe group (1% vs. 5% by the chi-square test).
The researchers conclude that this comparative-effectiveness trial shows that the use of extended-release niacin causes a significant regression of carotid intimamedia thickness when combined with a statin and that niacin is superior to ezetimibe. (ClinicalTrials.gov number, NCT00397657 [ClinicalTrials.gov] .) The study is published in the November 15 th , 2009 issue of the New England Journal of Medicine.