EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)(0653A-089)

Phase 4 Completed 367 enrolled Organon and Co

RandomizedParallel-groupOpen-labelTreatment

Summary

In patients with coronary artery disease and a LDL-C level between 2.5 mmol/L and 5.0 mmol/L on a stable (\> 4 weeks) statin starting dose (simvastatin 20 mg or atorvastatin 10 mg), investigate what the LCL-C lowering efficacy is of doubling the statin dose (to 40 mg simvastatin or 20 mg atorvastatin) versus a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. It is postulated that more patients reach their LDL-C treatment goal with the combination tablet compared to doubling the starting dose. Furthermore, the effect of both treatment regimens on other lipid parameters, safety and LDL-subfractions will be measured.

Timeline

Start: 2005-11
Primary completion: 2007-02
Completion: 2007-02

Outcome

Met primary endpoint

paper 119 of 178 (67%) patients in the EZE/SIMVA group and 49 of 189 (26%) in the doubling statin group reached target LDL-C < 2.5 mmol/L. PMID 18226326 ↗

paper switching to the EZE/SIMVA was more effective in attaining the LDL-C target of < 2.5 mmol/L than doubling the statin dose. PMID 18226326 ↗

Publications

Roeters van Lennep HW, Liem AH, Dunselman PH, Dallinga-Thie GM, Zwinderman AH, Jukema JW. The efficacy of statin monotherapy uptitration versus switching to ezetimibe/simvastatin: results of the EASEGO study. Curr Med Res Opin. 2008 Mar;24(3):685-94. doi: 10.1185/030079908X273273. Epub 2008 Jan 25.

Drugs

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