Safety and Efficacy of Ezetimibe/Simvastatin Combination Versus Atorvastatin Alone in Adults ≥65 Years of Age With Hypercholesterolemia and With or at Moderately High/High Risk for Coronary Heart Disease (the VYTELD Study)

Higher than 80% of coronary heart disease-related mortality occurs in patients >= 65 years of age Guidelines recommend low-density lipoprotein (LDL) cholesterol targets for these at-risk patients, however, few clinical studies have evaluated lipid-lowering strategies specifically in older adults This multicenter, 12-week, randomized, double-blind, parallel-group trial evaluated the efficacy and safety of the usual starting dose of ezetimibe/simvastatin (10/20 mg) versus atorvastatin 10 or 20 mg and the next higher dose of ezetimibe/simvastatin (10/40 mg) versus atorvastatin 40 mg in 1,289 hypercholesterolemic patients years of age with or without cardiovascular disease Patients randomized to ezetimibe/simvastatin had greater percent decreases in LDL cholesterol (-54 2% for 10/20 mg vs -39 5% and -46 6% for atorvastatin 10 and 20 mg, respectively, -59 1% for 10/40 mg vs -50 8% for atorvastatin 40 mg, p <0 001 for all comparisons) and the number attaining LDL cholesterol <70 mg/dl (51 3% for 10/20 mg, 68 2% for 10/40 mg) and <100 mg/dl (83 6% for 10/20 mg, 90 3% for 10/40 mg) was significantly larger compared to those receiving atorvastatin for all prespecified dose comparisons (p <0 05 to <0 001) A significantly larger percentage of high-risk patients achieved LDL cholesterol <70 mg/dl on ezetimibe/simvastatin 10/20 mg (54 3%) versus atorvastatin 10 mg (10 9%, p <0 001) or 20 mg (28 9%, p <0 001) and ezetimibe/simvastatin 10/40 mg (69 2%) versus atorvastatin 40 mg (38 2%, p <0 001), and a significantly larger percentage of intermediate-risk patients achieved LDL cholesterol <100 mg/dl on ezetimibe/simvastatin 10/20 mg (82 1%) versus atorvastatin 10 mg (59 3%, p <0 05) Improvements in non-high-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and lipoprotein ratios were significantly greater with ezetimibe/simvastatin than atorvastatin for all comparisons (p <0 01 to <0 001) High-density lipoprotein cholesterol and triglyceride results were variable All treatments were generally well tolerated In conclusion, ezetimibe/simvastatin provided significantly greater improvements in key lipid parameters and higher attainment of LDL cholesterol targets than atorvastatin, with comparable tolerability (C)2010 Elsevier Inc All rights reserved (Am J Cardiol 2010,106 1255-1263)