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

Background: 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.

Methods: 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.

Results: 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.

Conclusions: This study demonstrated that combination therapy with atorvastatin plus ER niacin and colesevelam can safely and effectively treat dyslipidemia in subjects with atherosclerotic disease.