摘要Background Cholesterol-lowering therapy with statins has been reported to reduce the morbidity and mortality of cardiovascular diseases. This study aimed to investigate the effects of combined application of extended-release niacin and atorvastatin on lipid profile modification and the risks of adverse events in patients with coronary artery disease. Methods Consecutive 108 patients with coronary artery disease and serum total cholesterol (TC) ≥ 3.5 mmol/L were randomized into two groups: group A using atorvastatin and group B using extended-release niacin (niacin ER) and atorvastatin. Plasma lipid profile, glucose, and adverse events were assessed at the hospitalization, and 6 and 12 months after treatment. In addition, clinical cardiovascular events were evaluated after 12 months of treatment. Results The levels of TC, low density lipoprotein cholesterol (LDL-C) were significantly decreased (P<0.05) in groups A and B, but the levels of high density lipoprotein cholesterol (HDL-C) and ApoA increased by 29.36% and 40.81% respectively after 12 months of treatment in group B (P<0.01). The medications were generally well tolerated in the two groups. No significant difference of adverse events was found between the two groups (group A: 3.2% vs group B 5.1%, P >0.05). Conclusions Combined use of extended-release niacin with atorvastatin was superior to atorvastatin monotherapyalone in lipid profile regulation. Combination therapy with niacin ER and atorvastatin was well tolerated and safe in patients with coronary artery disease.