TITLE

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

AUTHOR(S)
Pearson, Thomas A.; Denke, Margo A.; McBride, Patrick E.; Battisti, Wendy P.; Brady, William E.; Palmisano, Joanne
PUB. DATE
May 2005
SOURCE
Mayo Clinic Proceedings;May2005, Vol. 80 Issue 5, p587
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
OBJECTIVE: To determine the extent of reduction in low-density Ilpoproteln 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. PATIENTS AND METHODS: in this multicenter, double-blind, placebo-controlled trial (from January 2003 to August 2003), hypercholes-teroiemic 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. RESULTS: 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 ill 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. CONCLUSION: Across multiple subgroups, ezetimibe added to stat In therapy consistently produced significant additional improvements in LDL-C levels and goal attainment, as well as in other Ilpoproteins, 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.
ACCESSION #
17019192

 

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