Effects of adding extended-release niacin and colesevelam to statin therapy on lipid levels in subjects with atherosclerotic disease

Abstract

The use of combination therapies is needed to treat dyslipidemia in patients with both elevated low-density lipoprotein cholesterol (LDL-C) and low high-density lipoprotein cholesterol (HDL-C). We conducted a study to assess the efficacy and safety of combination therapy with statin plus extended-release (ER) niacin and colesevelam, aimed at lowering LDL-C and raising HDL-C, in subjects with atherosclerotic disease. This 1-year study randomized 123 subjects with atherosclerotic disease to atorvastatin alone, double therapy with atorvastatin plus ER niacin, or triple therapy with atorvastatin, plus ER niacin and colesevelam. Target LDL-C was ≤80 mg/dL for single and double therapy, and ≤60 mg/dL for triple therapy. Target HDL-C was an increase of ≥10 mg/dL for double and triple therapy. Single therapy, with mean atorvastatin dose 30 mg/day, had a 47% reduction in LDL-C (P < 0.001) from 148 ± 29 mg/dL to 77 ± 15 mg/dL. With the addition of ER niacin, the double therapy had a 25% increase in HDL-C, from 42 ± 11 mg/dL to 53 ± 16 mg/dL (P < 0.001). The triple therapy decreased LDL-C by 57%, from 157 ± 29 mg/dL to 66 ± 18 mg/dL (P < 0.001), and increased HDL-C by 29%, from 40 ± 9 mg/dL to 50 ± 14 mg/dL (P < 0.001). Double and triple therapy required a lower atorvastatin dose of 20 mg/day to reach the target LDL-C levels. On average, 75% and 67% of subjects reached the predefined LDL-C and HDL-C treatment targets. No related myopathy or hepatotoxicity required stopping the therapy. This study demonstrated that combination therapy with atorvastatin plus ER niacin and colesevelam can safely and effectively treat dyslipidemia in subjects with atherosclerotic disease.