21029821

pubmed:Citation

9

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 ?65 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.

eng

AIM

MEDLINE

1879-1913

Copyright © 2010 Elsevier Inc. All rights reserved.

1

NLM

1255-63

pubmed-meshheading:21029821-Aged, pubmed-meshheading:21029821-Anticholesteremic Agents, pubmed-meshheading:21029821-Azetidines, pubmed-meshheading:21029821-Biological Markers, pubmed-meshheading:21029821-Coronary Disease, pubmed-meshheading:21029821-Dose-Response Relationship, Drug, pubmed-meshheading:21029821-Double-Blind Method, pubmed-meshheading:21029821-Drug Therapy, Combination, pubmed-meshheading:21029821-Female, pubmed-meshheading:21029821-Heptanoic Acids, pubmed-meshheading:21029821-Humans, pubmed-meshheading:21029821-Hypercholesterolemia, pubmed-meshheading:21029821-Lipids, pubmed-meshheading:21029821-Logistic Models, pubmed-meshheading:21029821-Male, pubmed-meshheading:21029821-Pyrroles, pubmed-meshheading:21029821-Risk Factors, pubmed-meshheading:21029821-Simvastatin, pubmed-meshheading:21029821-Treatment Outcome

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).

Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study