Abstract
BackgroundReducing 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.MethodsThis 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.ResultsAt 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.ConclusionEzetimibe 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 registrationRegistered at ClinicalTrials.gov: NCT00652327
Highlights
Reducing low-density lipoprotein cholesterol (LDL-C) is associated with reduced risk for major coronary events
Of the 202 patients screened, 83 were randomized, 42 were assigned to the ezetimibe added to ongoing statin treatment group, 41 were assigned to the double statin dose treatment group, and 20 patients had no post-randomization LDL-C values (13 patients from the ezetimibe group and 7 patients from the statin group)
Data from 5 subjects on statin treatment were missing from the study and included in the ITT analysis
Summary
Reducing low-density lipoprotein cholesterol (LDL-C) is associated with reduced risk for major coronary events. Chinese populations are perceived to have lower lowdensity lipoprotein cholesterol (LDL-C) levels and coronary heart disease (CHD) risk than Caucasians [1]. Reducing serum levels of LDL-C is associated with a reduction in risk for major coronary events [3,4,5,6,7,8,9] and greater reduction in ischemic heart disease [10]. HMG-CoA reductase inhibitors (statins) are the first line of therapy as an adjunct to TLCs [14,15] They inhibit cholesterol synthesis in the liver and dose-dependent reductions in LDL-C range from 20% to 60%, depending on the drug and dosage used [16,17,18,19,20,21]
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