Ezetimibe and simvastatin and Niacin interaction

…well-controlled LDL-C levels on simvastatin 40 mg/day with or without ezetimibe 10 mg/day, there was no incremental benefit on cardiovascular outcomes with the addition of lipid-modifying doses of niacin Intervention: Concomitant use of VYTORIN with lipid-modifying dosages of niacin is not recommended in Chinese patients [see Use in Specific Populations (8.8) ] .

Lipid modifying doses (≥1 gram/day) of niacin, fibrates, colchicine, and grapefruit juice may also increase the risk of myopathy and rhabdomyolysis [see Drug Interactions (7.1) ] .

Niacin Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of lipid modifying dosages of niacin-containing products (≥1 gram/day niacin) with VYTORIN.

For non-Chinese patients, consider if the benefit of using lipid-modifying doses of niacin concomitantly with VYTORIN outweighs the increased risk of myopathy and rhabdomyolysis.

HDL-C increased by 25.0% to 42 mg/dL in the simvastatin plus niacin extended-release tablets group and by 9.8% to 38 mg/dL in the simvastatin plus placebo group (P<0.001).

Triglyceride levels decreased by 28.6% in the simvastatin plus niacin extended-release tablets group and by 8.1% in the simvastatin plus placebo group.

The risk for myopathy and rhabdomyolysis are increased among elderly patients; patients with diabetes, renal failure, or uncontrolled hypothyroidism; and patients being treated with a statin.

Mortality and Coronary Heart Disease Morbidity Niacin extended-release tablets have not been shown to reduce cardiovascular morbidity or mortality among patients already treated with a statin.

Skeletal Muscle Cases of rhabdomyolysis have been associated with concomitant administration of lipid-altering doses (≥1 g/day) of niacin and statins.