Comparison of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Statin in the Treatment of Hypercholesterolemia (P04355)

Summary

This is a randomized, open label, parallel group comparison study. Following a 1-week screening period, patients will be randomized to 1 of 2 treatment groups: ezetimibe added to ongoing statin treatment (ezetimibe plus simvastatin, atorvastatin or pravastatin at doses of 10/20, 10/10 or 10/20 mg), or doubling the dose of ongoing statin (simvastatin 40 mg, atorvastatin 20 mg, or pravastatin 40 mg). Study drug will be administered once daily in the evening for 8 weeks. Patients will be instructed to follow a National Cholesterol Education Program (NCEP) or similar cholesterol-lowering dietary regimen throughout the study.

Timeline

Start

2005-12

Primary completion

2007-07

Completion

2007-07

Outcome

Met primary endpoint

paper significantly greater reductions compared with doubling the statin dose in LDL-C (26.2% vs 17.9%, p = 0.0026) PMID 22621316 ↗

registry analysis (unspecified test); Ezetimibe + Statin vs Double Statin; p = .0026; Wilcoxon rank sum test NCT00652327 ↗

Publications

• Yu CC, Lai WT, Shih KC, Lin TH, Lu CH, Lai HJ, Hanson ME, Hwang JJ. 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 Res Notes. 2012 May 23;5:251. doi: 10.1186/1756-0500-5-251.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atorvastatin	Small molecule	10 mg	—
Subject	Atorvastatin	Small molecule	20 mg	—
Subject	Ezetimibe	Unknown	10 mg	—
Subject	Pravastatin	Small molecule	20 mg	—
Subject	Pravastatin	Small molecule	40 mg	—
Subject	Simvastatin	Small molecule	20 mg	—
Subject	Simvastatin	Small molecule	40 mg	—

Indications