Fixed-dose combination of extended-release niacin plus simvastatin for lipid disorders.

Coronary heart disease (CHD) carries significant morbidity and mortality worldwide. Elevated LDL-cholesterol and reduced HDL-cholesterol levels are well-recognized CHD risk factors. Despite guideline recommendations for intensive therapy among patients at high risk for CHD to lower LDL-cholesterol, such lowering has failed to prevent approximately two-thirds of cardiovascular events. As a result of new data, guidelines have begun to focus on non-HDL-cholesterol, HDL-cholesterol and triglycerides as treatment targets, with the end result being a recommendation for combination therapy, such as niacin plus statin for the treatment of dyslipidemia. Compared with statin monotherapy, a combination of niacin and statin therapy provides beneficial effects on a broad range of lipid particles and some evidence suggests a further reduction in CHD risk. Recent studies have shown that the combination of a fixed dose of extended-release niacin plus simvastatin reduces non-HDL-cholesterol, LDL-cholesterol, triglycerides and total cholesterol:HDL-cholesterol ratio by approximately 50% while increasing HDL-cholesterol by 25%. The safety of this combination is consistent with the safety profiles of each individual component and is well tolerated. A long-term study is currently being conducted to evaluate whether this combination therapy confers an additive impact on clinical end points.