Simvastatin/Nicotinic Acid

Muscle complaints, including rhabdomyolysis (severe muscle damage), related to the cholesterol-lowering medications known as statins, are a class effect. Following preliminary data from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial showing increased muscle injuries, the Food and Drug Administration (FDA) began reviewing the safety of simvastatin, particularly the high-dose 80-mg simvastatin, in March 2010. On June 8, 2011, the Food and Drug Administration (FDA) released the updated product information with revised safety warnings regarding myopathy and rhabdomyolysis associated with products for high cholesterol that contain simvastatin. Simvastatin is the generic form of Zocor and is the statin contained in both Vytorin (simvastatin and ezetimibe) and Simcor (simvastatin and niacin extended-release). From the SEARCH trial and analysis of the FDA’s Adverse Event Reporting System (AERS) database, the FDA found that fatal rhabdomyolysis was significantly more common with 80 mg compared with 20 mg of simvastatin, and that overall rates of myopathy and rhabdomyolysis were higher in simvastatin 80 mg versus lower doses of simvastatin or other statins (e.g., atorvastatin, pravastatin, etc.). The risks for both myopathy and rhabdomyolysis were highest for 80 mg simvastatin during the first 12 months of treatment and are shown in Table 1. Both older age and female sex were seen as risk factors for

Oral fixed-dose niacin extended release/simvastatin is associated with clinically relevant improvements in plasma lipid profiles, including lowering of non-high-density lipoprotein cholesterol levels, relative to simvastatin monotherapy in patients with mixed dyslipidemias who had not responded fully to simvastatin monotherapy, and is generally well tolerated.