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Effectiveness of Ezetimibe Added to Ongoing Statin Therapy in Modifying Lipid Profiles and Low-Density Lipoprotein Cholesterol Goal Attainment in Patients of Different Races and Ethnicities: A Substudy of the Ezetimibe Add-On to Statin for Effectiveness Trial


      To examine whether the improvements in lipid profiles and low-density lipoprotein cholesterol (LDL-C) goal attainment found in the Ezetimibe Add-On to Statin for Effectiveness trial occurred equally in the black, Hispanic, and white patient populations enrolled in the study.


      In this double-blind, placebo-controlled study, patients were recruited from 299 community-based practices across the United States (January to August 2003). Patients with hypercholesterolemia and LDL-C levels exceeding National Cholesterol Education Program Adult Treatment Panel III goals were randomized (2:1) to receive either ezetimibe (10 mg/d) or placebo in addition to their ongoing statin therapy for 6 weeks.


      A total of 5802 patients were screened at baseline for the Ezetimibe Add-On to Statin for Effectiveness study. Of these, 2772 were excluded, and the remaining 3030 eligible patients were randomized. Ezetimibe, compared with placebo, added to statin therapy significantly reduced LDL-C levels from statin-treated baseline by 23.0% (white patients), 23.0% (black patients), and 21.0% (Hispanic patients). This effect was consistent across race and ethnicity groups (P>.50 for treatment-byrace interactions). Ezetimibe added to statin therapy also statistically significantly (P<.001) increased the percentage of patients attaining their LDL-C goal for their National Cholesterol Education Program Adult Treatment Panel III risk category in black (63.0%), Hispanic (64.8%), and white (72.3%) patients compared with placebo plus statin (32.9% black patients, 19.0% Hispanic patients, and 19.7% white patients). Ezetimibe treatment improved other lipid parameters across groups, including triglyceride, high-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, and total cholesterol levels. Finally, the addition of ezetimibe reduced high-sensitivity C-reactive protein levels overall, and no significant interaction of treatment by race occurred (P=.83), indicating a consistent effect across races. Ezetimibe was generally well tolerated, and no detectable differences occurred in the adverse event profile by race or ethnicity.


      Ezetimibe added to statin therapy is effective and well tolerated for improving the lipid profile and LDL-C goal attainment of patients regardless of race or ethnicity.
      AE (adverse event), ALT (alanine aminotransferase), ANOVA (analysis of variance), AST (aspartate aminotransferase), CHD (coronary heart disease), CK (creatine kinase), CRP (C-reactive protein), CVD (cardiovascular disease), EASE (Ezetimibe Add-On to Statin for Effectiveness), HDL-C (high-density lipoprotein cholesterol), LDL-C (low-density lipoprotein cholesterol), NCEP ATP III (National Cholesterol Education Program Adult Treatment Panel III), TG (triglyceride), ULN (upper limit of normal)
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