Evidence for... Niacin for high cholesterol

Comparison of the safety and efficacy of a combination tablet of niacin extended release and simvastatin vs simvastatin monotherapy in patients with increased non-HDL cholesterol (from the SEACOAST I study).
Ballantyne CM et al.
Am J Cardiol. 2008;101:1428-36.
The SEACOAST I study evaluated the efficacy and safety of extended-release (ER) niacin/low-dose simvastatin combination (ER niacin 1 g/simvastatin 20 mg; or ER niacin 2 g/simvastatin 20 mg) compared with simvastatin 20 mg alone in patients with elevated non-HDL-cholesterol (type II hyperlipidaemia or mixed dyslipidaemia) who had already been on simvastatin monotherapy. Patients receiving combination treatment achieved 14% (1 g/20 mg) and 23% (2 g/20 mg) reductions in non-HDL-cholesterol versus a 7% reduction with simvastatin 20 mg alone. Combination treatment also resulted in significant improvements in HDL-cholesterol and triglycerides compared with simvastatin monotherapy.


Comparison of the efficacy and safety of a combination tablet of niacin extended-release and simvastatin with simvastatin 80 mg monotherapy:
The SEACOAST II (high-dose) study.
Ballantyne CM et al.
J Clin Lipidol. 2008;2:79-90.
The SEACOAST II study evaluated the efficacy and safety of extended-release (ER) niacin/high-dose simvastatin combination (ER niacin 2 g/simvastatin 40 mg; or ER niacin 1 g/simvastatin 40 mg) compared with simvastatin 80 mg alone in patients with elevated non-HDL-cholesterol (type II hyperlipidaemia or mixed dyslipidaemia) who had already been on simvastatin monotherapy. Combination therapy showed non-inferiority in reducing non-HDL-cholesterol, with decreases of about 11% (1 g/40 mg) and 17% (2 g/40 mg) compared with a 10% reduction with simvastatin 80 mg alone. Both combination treatment doses were associated with significant improvements in other lipid parameters, including HDL-cholesterol, triglycerides, lipoprotein (a), and apolipoprotein A-1. Three times more patients on ER niacin 2 g/simvastatin 40 mg achieved their lipid goals than patients on simvastatin 80 mg monotherapy.

Long-term safety and efficacy of a combination of niacin extended release and simvastatin in patients with dyslipidemia: the OCEANS study.
Karas RH et al.
Am J Cardiovasc Drugs. 2008;8:69-81.
A combination of niacin extended-release and simvastatin (titrated to a maximum dosage of 2 g/40 mg) over 52 weeks provided additional, clinically relevant improvements in multiple lipid parameters beyond statin monotherapy in patients with mixed dyslipidaemia.