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Atorvastatin 10 mg plus ezetimibe versus titration to atorvastatin 40 mg: attainment of European and Canadian guideline lipid targets in high-risk subjects ≥65 years

Christian Constance1*, Ori Ben-Yehuda2, Nanette K Wenger3, Franklin Zieve4, Jianxin Lin5, Mary E Hanson5, Robert S Lowe5 and Andrew M Tershakovec5

Author Affiliations

1 Hopital Maisonneuve-Rosemont Recherche Clinique/Polyclinique, 5415 Boulevard de l’Assomption, Suite 295, H1T 2 M4 Montreal, QC, Canada

2 Clinical Trial Center, Cardiovascular Research Foundation, New York, NY, USA

3 Emory University School of Medicine, Altanta, GA, USA

4 McGuire VA Medical Center, Richmond, VA, USA

5 Merck & Co. Inc., Whitehouse Station, NJ, USA

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Lipids in Health and Disease 2014, 13:13  doi:10.1186/1476-511X-13-13

Published: 13 January 2014

Abstract

Background

Few clinical studies have focused on the efficacy of lipid-lowering therapies in patients ≥65 years.

Methods

After stabilization on atorvastatin 10 mg, hypercholesterolemic subjects ≥65 years at high/very high risk for CHD and not at LDL-C <1.81 mmol/L (with atherosclerotic vascular disease [AVD]) or <2.59 mmol/L (without AVD) were randomized to ezetimibe 10 mg plus atorvastatin 10 mg or uptitration to atorvastatin 20 mg (6 weeks) followed by uptitration to 40 mg (additional 6 weeks). A post-hoc analysis compared between-group differences in percent attainment of individual and combined LDL-C, non-HDL-C and Apo B targets based on recommendations from 2012 European and Canadian Cardiovascular Society (CCS) guidelines for dyslipidemia treatment.

Results

Atorvastatin 10 mg plus ezetimibe produced significantly greater attainment of LDL-C, non-HDL-C, and Apo B individual and dual/triple targets vs. atorvastatin 20 mg for the entire cohort and very high-risk groups at 6 weeks. After 12 weeks, very high-risk subjects maintained significantly greater achievement of LDL-C <1.8 mmol/L (47% vs. 35%), non-HDL-C <2.6 mmol/L (63% vs. 53%) and Apo B <0.8 g/L (47% vs. 38%) single targets and dual/triple targets with atorvastatin 10 mg plus ezetimibe vs. atorvastatin 40 mg, while attainment of European target for high-risk subjects was generally similar for both treatments. Achievement of Canadian targets was significantly greater with combination therapy vs. atorvastatin 20 mg (6 weeks) or atorvastatin 40 mg (12 weeks).

Conclusions

Atorvastatin 10 mg plus ezetimibe provided more effective treatment than uptitration to atorvastatin 20/40 mg for attainment of most European and Canadian guideline-recommended lipid targets in older at-risk patients.

Trial registration

ClinicalTrials.gov identifier NCT00418834.

Keywords:
Ezetimibe; Atorvastatin; Hyperlipidemia; Elderly; Statin; Combination therapy