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)
摘要：该研究选择患有高胆固醇血症、且已患冠心病或有中高度冠心病风险的65岁以上患者，采用依折麦布/辛伐他汀10/20 mg、10/40 mg分别与阿托伐他汀10 mg、20 mg、40 mg进行深入对比研究。结果显示，依折麦布和辛伐他汀联合用药后患者的脂质参数和低密度脂蛋白水平改善更明显，且对本研究的患者来说，耐受性更佳。
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, parallelgroup 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 10/20mg vs 39.5% and 46.6% for atorvastatin 10 and 20 mg, respectively; 59.1% for 10/40mg 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 <100mg/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 20mg (28.9%, p <0.001) and ezetimibe/simvastatin 10/40 mg (69.2%) versus atorvastatin 40mg (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.
