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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.
Mayo Clin Proc. 2005 May; 80(5):587-95.MC

Abstract

OBJECTIVE

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.

PATIENTS AND METHODS

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.

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 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.

CONCLUSION

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.

Authors+Show Affiliations

Pearson TA
Department of Community & Preventive Medicine, University of Rochester School of Medicine and Dentistry, 601 Elmwood Ave, Box 644, Rochester, NY 14642, USA.
Denke MA
No affiliation info available
McBride PE
No affiliation info available
Battisti WP
No affiliation info available
Brady WE
No affiliation info available
Palmisano J
No affiliation info available

MeSH

AgedAnticholesteremic AgentsAtorvastatinAzetidinesCholesterol, LDLDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationEzetimibeFatty Acids, MonounsaturatedFemaleFluvastatinFollow-Up StudiesHeptanoic AcidsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaIndolesLovastatinMaleMiddle AgedNephelometry and TurbidimetryPractice Guidelines as TopicPravastatinPyrrolesRetrospective StudiesRisk FactorsSimvastatin

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15887425

Clinical Trial Links

Study of an Approved Drug With a Statin (a Medication That Lowers Cholesterol Levels) as Compared to Statin Therapy Alone in Patients With High Cholesterol (0653-040)

Citation

Pearson, Thomas A., et al. "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." Mayo Clinic Proceedings, vol. 80, no. 5, 2005, pp. 587-95.
Pearson TA, Denke MA, McBride PE, et al. 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. Mayo Clin Proc. 2005;80(5):587-95.
Pearson, T. A., Denke, M. A., McBride, P. E., Battisti, W. P., Brady, W. E., & Palmisano, J. (2005). 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. Mayo Clinic Proceedings, 80(5), 587-95.
Pearson TA, et al. 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. Mayo Clin Proc. 2005;80(5):587-95. PubMed PMID: 15887425.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Pearson,Thomas A, AU - Denke,Margo A, AU - McBride,Patrick E, AU - Battisti,Wendy P, AU - Brady,William E, AU - Palmisano,Joanne, PY - 2005/5/13/pubmed PY - 2005/5/25/medline PY - 2005/5/13/entrez SP - 587 EP - 95 JF - Mayo Clinic proceedings JO - Mayo Clin Proc VL - 80 IS - 5 N2 - OBJECTIVE: 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. PATIENTS AND METHODS: 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. 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 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. CONCLUSION: 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. SN - 0025-6196 UR - https://www.unboundmedicine.com/medline/citation/15887425/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_ DB - PRIME DP - Unbound Medicine ER -
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