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EASE Trial. Ezetimibe Add-on to Statin Therapy for Effectiveness Trial. Presented at American College of Cardiology Scientific Sessions 2004 Presented by Dr. Thomas Pearson. EASE Trial.
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EASE Trial Ezetimibe Add-on to Statin Therapy for Effectiveness Trial Presented at American College of Cardiology Scientific Sessions 2004 Presented by Dr. Thomas Pearson
EASE Trial 3,030 Patients with low-density lipoprotein (LDL) cholesterol exceeding National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III goals. Randomized, double-blind, multicenter Placebo n=1,010 Ezetimibe n=2,020 Treatment Added to a dose of any statin (40% atorvastatin, 29% simvastatin, 22% pravastatin, 10% other) • Endpoints (6 weeks): Percent change from baseline in LDL cholesterol in the overall population and by NCEP ATP III CHD risk category Presented at ACC Scientific Sessions 2004
EASE Trial Increase in High-Density Lipoprotein (HDL) p<0.001 Reduction in Triglycerides p<0.001 • A large proportion of patients in the trial had diabetes (38.4%) and metabolic syndrome by NCEP ATP III criteria (60%). • Baseline LDL levels were 129 mg/dl in the overall population, 123 mg/dl in the coronary heart disease (CHD) or CHD risk equivalent group, 147 mg/dl in the multiple risk factors group, and 167 mg/dl in the <2 risk factors group. • The ezetimibe arm had a larger reduction in triglycerides and a larger increase in high-density lipoprotein (HDL) levels. mg/dl Ezetimibe Placebo Ezetimibe Placebo Presented at ACC Scientific Sessions 2004
EASE Trial Reached Target LDL Goals p<0.001 Reduction in LDL p<0.001 • In the overall study population, a larger percent change from baseline in LDL levels occurred in the ezetimibe arm versus placebo. • The follow-up LDL level in the ezetimibe arm was 95 mg/dl. • A larger percentage of patients in the ezetimibe arm reached target LDL goals. • Results were similar across the different statin brands and by the prespecified subgroups of age group, gender, and diabetes status. mg/dl Ezetimibe Placebo Ezetimibe Placebo Presented at ACC Scientific Sessions 2004
EASE Trial Reduction in LDL p<0.001 Reached Target LDL Goals p<0.001 mg/dl <2 CHD Risk Factor CHD/CHD Equivalent Multiple Risk Factor <2 CHD Risk Factor CHD/CHD Equivalent Multiple Risk Factor • Similar results were observed in the CHD/CHD risk equivalent subgroup, the multiple risk factor subgroup, and the <2 CHD risk factor subgroup. • There were no increases in the frequency of alanine aminotransferase (ALT) ≥3 times upper limit of normal (ULN) (0.4% for ezetimibe vs. 0.2% for placebo), aspartate aminotransferase (AST) ≥3 times ULN (0.2% vs. 0.1%), or creatine kinase (CK) ≥10 times ULN (0 in both groups). Presented at ACC Scientific Sessions 2004
EASE Trial • Among patients with LDL cholesterol exceeding NCEP ATP III goals and on statin therapy, additional treatment with ezetimibe was associated with a larger reduction in LDL cholesterol and a greater number of patients meeting LDL target goals compared with placebo, with no additional safety issues. • The 23% larger reduction in LDL levels was higher than the 6-8% reduction usually observed by doubling the statin dose. • The present trial adds to the growing body of studies showing an added benefit with ezetimibe in addition to statin therapy. Earlier trials used a selected statin rather than any statin, as in the present trial, which represents a "real-world" evaluation regarding the use of concomitant ezetimibe therapy.