A Community-Based, Randomized Trial of Ezetimibe Added to Statin Therapy to Attain NCEP ATP III Goals for LDL Cholesterol in Hypercholesterolemic Patients: The Ezetimibe Add-On to Statin for Effectiveness (EASE) Trial

• Published in: Mayo Clinic proceedings Vol. 80; no. 5; pp. 587 - 595
• Main Authors: Pearson, Thomas A., Denke, Margo A., McBride, Patrick E., Battisti, Wendy P., Brady, William E., Palmisano, Joanne
• Format: Journal Article
• Language: English
• Published: Rochester, MN Elsevier Inc 01.05.2005; Mayo Medical Ventures; Elsevier Limited
• Subjects: Aged; Anticholesteremic Agents - therapeutic use; Atorvastatin Calcium; Azetidines - therapeutic use; Biological and medical sciences; Cholesterol, LDL - blood; Disorders of blood lipids. Hyperlipoproteinemia; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Ezetimibe; Fatty Acids, Monounsaturated - therapeutic use; Female; Follow-Up Studies; General aspects; Heptanoic Acids - therapeutic use; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Hypercholesterolemia - blood; Hypercholesterolemia - drug therapy; Indoles - therapeutic use; Lovastatin - therapeutic use; Male; Medical sciences; Metabolic diseases; Middle Aged; Nephelometry and Turbidimetry; Practice Guidelines as Topic; Pravastatin - therapeutic use; Pyrroles - therapeutic use; Retrospective Studies; Risk Factors; Simvastatin - therapeutic use; HDL-C; AST; TG; NCEP ATP III; LDL-C; CI; ULN; CK; ALT; hs-CRP; CHD; Human; Ezetimibe; Metabolic diseases; Cholesterol LDL; Lipids; Patient; Hyperlipoproteinemia; Statin derivative; Adult Treatment Panel III; Lipoprotein; Medicine; Hypercholesterolemia; Treatment; Efficiency; Clinical trial; Dyslipemia; Community; Antilipemic agent
• ISSN: 0025-6196; 1942-5546
• DOI: 10.4065/80.5.587

To determine the extent of reduction in low-density lipoprotein cholesterol (LDL-C) level and improvement in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal attainment when ezetimibe was added to ongoing statin therapy in a diverse population of community-based patients. In this multicenter, double-blind, placebo-controlled trial (from January 2003 to August 2003), hypercholesterolemic patients (from 299 US primary care and specialty practices) with LDL-C levels exceeding NCEP ATP III goals were randomized (2:1) to receive ezetimibe (10 mg/d) or placebo in addition to their ongoing statin therapy for 6 weeks. In a study of 3030 randomized patients, ezetimibe added to statin therapy significantly reduced the LDL-C level by an additional 25.8% in the total population, compared with an additional 2.7% reduction with placebo plus statin (treatment difference, -23.1%; P<.001); the treatment difference ranged from -19.9% to -24.0% ( P<.001) in each NCEP ATP III risk category subgroup. Significantly ( P<.001) more patients (71.0%) treated with ezetimibe added to statin reached their NCEP ATP III target LDL-C level compared with those treated with placebo plus statin (20.6%). The addition of ezetimibe also resulted in improvement in other lipid parameters and high-sensitivity C-reactive protein levels. These benefits were consistent across sex, race, age, statin brand, and dose subgroups. Ezetimibe plus statin therapy was well tolerated, with a safety profile similar to placebo plus statin. Across multiple subgroups, ezetimibe added to statin therapy consistently produced significant additional improvements in LDL-C levels and goal attainment, as well as in other lipoproteins, compared with addition of placebo. The addition of ezetimibe to statin therapy should be considered for patients not achieving their NCEP ATP III LDL-C goals while receiving statin therapy alone.