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Open Access Research article

Efficacy, safety and tolerability of ongoing statin plus ezetimibe versus doubling the ongoing statin dose in hypercholesterolemic Taiwanese patients: an open-label, randomized clinical trial

Chih-Chieh Yu1, Wen-Ter Lai2, Kuang-Chung Shih3, Tsung-Hsien Lin2, Chieh-Hua Lu3, Hung-Jen Lai4, Mary E Hanson5 and Juey-Jen Hwang6*

Author Affiliations

1 National Taiwan University Hospital, Taipei, Taiwan

2 Division of Cardiology, Department of Internal Medicine, Kaohsiung Medical University Hospital and Department of Internal Medicine, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan

3 Tri-Service General Hospital, Taipei, Taiwan

4 MSD Taiwan, Taipei, Taiwan

5 Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA

6 Cardiovascular Division, Department of Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan

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BMC Research Notes 2012, 5:251  doi:10.1186/1756-0500-5-251

Published: 23 May 2012

Abstract

Background

Reducing low-density lipoprotein cholesterol (LDL-C) is associated with reduced risk for major coronary events. Despite statin efficacy, a considerable proportion of statin-treated hypercholesterolemic patients fail to reach therapeutic LDL-C targets as defined by guidelines. This study compared the efficacy of ezetimibe added to ongoing statins with doubling the dose of ongoing statin in a population of Taiwanese patients with hypercholesterolemia.

Methods

This was a randomized, open-label, parallel-group comparison study of ezetimibe 10 mg added to ongoing statin compared with doubling the dose of ongoing statin. Adult Taiwanese hypercholesterolemic patients not at optimal LDL-C levels with previous statin treatment were randomized (N = 83) to ongoing statin + ezetimibe (simvastatin, atorvastatin or pravastatin + ezetimibe at doses of 20/10, 10/10 or 20/10 mg) or doubling the dose of ongoing statin (simvastatin 40 mg, atorvastatin 20 mg or pravastatin 40 mg) for 8 weeks. Percent change in total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C) and triglycerides, and specified safety parameters were assessed at 4 and 8 weeks.

Results

At 8 weeks, patients treated with statin + ezetimibe experienced significantly greater reductions compared with doubling the statin dose in LDL-C (26.2% vs 17.9%, p = 0.0026) and total cholesterol (20.8% vs 12.2%, p = 0.0003). Percentage of patients achieving treatment goal was greater for statin + ezetimibe (58.6%) vs doubling statin (41.2%), but the difference was not statistically significant (p = 0.1675). The safety and tolerability profiles were similar between treatments.

Conclusion

Ezetimibe added to ongoing statin therapy resulted in significantly greater lipid-lowering compared with doubling the dose of statin in Taiwanese patients with hypercholesterolemia. Studies to assess clinical outcome benefit are ongoing.

Trial registration

Registered at ClinicalTrials.gov: NCT00652327

Keywords:
Ezetimibe; Simvastatin; Atorvastatin; Pravastatin