Key result
Ezetimibe reduces LDL-C by ~18% compared to placebo.
Why the study?
Ezetimibe is a novel cholesterol absorption inhibitor whose efficacy and safety in primary hypercholesterolaemia required evaluation through pooled analysis of controlled studies.
RCT (n=1,719)
Double-blind
Randomized
Yes
Absolute Event Rate: 18.2% vs -0.9%
p-value: p=<0.01
Supports ezetimibe monotherapy for LDL-C reduction; extends non-statin options in primary hypercholesterolemia RCTs.
Ezetimibe is a novel cholesterol absorption inhibitor that blocks intestinal absorption of dietary and biliary cholesterol. Data from 1719 patients who participated in two multicentre, double-blind studies of ezetimibe were pooled to evaluate the drug's efficacy and safety in patients with primary hypercholesterolaemia. Following dietary stabilisation, a two- to 12-week washout period, and a four-week, single-blind, placebo lead-in period, patients were randomised to ezetimibe 10 mg or placebo once daily in the morning for 12 consecutive weeks. The primary efficacy endpoint was percent reduction in plasma low-density lipoprotein (LDL)-cholesterol from baseline at endpoint. Ezetimibe reduced LDL-cholesterol by a mean of 18.2% compared with an increase of 0.9% with placebo (p<0.01) and resulted in favourable, statistically significant changes in HDL-cholesterol, triglycerides and apo B. The response to ezetimibe was consistent across all subgroups analysed. Ezetimibe was well tolerated, with a safety profile similar to placebo.
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Knopp et al. (2003) conducted an RCT in Primary hypercholesterolaemia (n=1,719). Ezetimibe vs. Placebo was evaluated on Percent reduction in plasma low-density lipoprotein (LDL)-cholesterol from baseline (p=<0.01). Ezetimibe 10 mg once daily reduced LDL-cholesterol by a mean of 18.2% from baseline, compared with an increase of 0.9% in the placebo group (p<0.01).
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