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 Yu, Wen-Ter Lai, Kuang-Chung Shih, Tsung-Hsien Lin, Chieh-Hua Lu, Hung-Jen Lai, Mary E Hanson, Juey-Jen Hwang, Chih-Chieh Yu, Wen-Ter Lai, Kuang-Chung Shih, Tsung-Hsien Lin, Chieh-Hua Lu, Hung-Jen Lai, Mary E Hanson, Juey-Jen Hwang

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.

Figures

Figure 1
Figure 1
Dispositions of Patients.
Figure 2
Figure 2
Percent change from baseline in lipid levels after 8 weeks of treatment (ITT population).
Figure 3
Figure 3
Inter-individual variability in response to treatment in Taiwanese patients with hypercholesterolemia.

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