Management of complex lipid abnormalities with a fixed dose combination of simvastatin and extended release niacin.

Abstract

ER niacin combined with simvastatin provides an additional option for achieving LDL-C and non-HDL-C goals for cardiovascular prevention, with greater efficacy in those with triglyceride levels >200 mg/dL. ER niacin 1000 mg combined with simvastatin 20 mg reduced LDL-C by 6%, non-HDL-C by 7%, and triglycerides by 13%, and raised HDL-C by 11% compared to simvastatin 20 mg alone. The 2000 mg dose combined with simvastatin 20 to 40 mg raised reduced LDL-C by 7% to 24%, non-HDL-C by 16% to 28%, and triglycerides by 23% to 34%, and increased HDL-C by 18% to 22% compared to similar dose simvastatin therapy. While cardiovascular risk is reduced in proportion to the magnitude of LDL-C lowering, the additive benefit of raising HDL-C and lowering triglycerides remains to be determined. ER niacin-simvastatin is reasonably well tolerated, with a <7% discontinuation rate due to flushing in patients who used aspirin or non-steroidal anti-inflammatory medications as needed. However, drop-out rates were high in both the simvastatin and ER niacin-simvastatin treatment groups in both the 24- and 52-week studies. The safety profile of the combination appears to be similar to that of niacin and simvastatin used as monotherapies. Results of ongoing morbidity/mortality trials of ER niacin added to statin therapy are eagerly awaited.