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

BMC Research Notes

Juey-Jen Hwang³  Mary E Hanson⁴  Hung-Jen Lai²  Chieh-Hua Lu¹  Tsung-Hsien Lin⁵  Kuang-Chung Shih¹  Wen-Ter Lai⁵  Chih-Chieh Yu⁶ 

[1] Tri-Service General Hospital, Taipei, Taiwan;MSD Taiwan, Taipei, Taiwan;Cardiovascular Division, Department of Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan;Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA;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;National Taiwan University Hospital, Taipei, Taiwan

关键词: Pravastatin;    Atorvastatin;    Simvastatin;    Ezetimibe;   

Others  :  1166398
DOI  :  10.1186/1756-0500-5-251

 received in 2011-08-23, accepted in 2012-05-23,  发布年份 2012

【 摘 要 】

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

【 授权许可】

   
2012 Yu et al.; licensee BioMed Central Ltd.

【 图 表 】

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