A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)

Phase 3 Completed 1289 enrolled Organon and Co Merck Shering-Plough JV Study · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.

Timeline

Start: 2007-11
Primary completion: 2009-03
Completion: 2009-03

Outcome

Met primary endpoint

registry analysis (unspecified test); Atorvastatin 10 mg vs Ezetimibe 10 mg/Simvastatin 20 mg; p <0.001; Mean Difference (Final Values) -14.7 (95% CI -17.5 to -12.0); ANCOVA NCT00535405 ↗

paper (-54.2% for 10/20 mg vs -39.5% and -46.6% for atorvastatin 10 and 20 mg, respectively PMID 21029821 ↗

paper -59.1% for 10/40 mg vs -50.8% for atorvastatin 40 mg; p <0.001 for all comparisons PMID 21029821 ↗

Publications

Results Foody JM, Brown WV, Zieve F, Adewale AJ, Flaim D, Lowe RS, Jones-Burton C, Tershakovec AM. Safety and efficacy of ezetimibe/simvastatin combination versus atorvastatin alone in adults >/=65 years of age with hypercholesterolemia and with or at moderately high/high risk for coronary heart disease (the VYTELD study). Am J Cardiol. 2010 Nov 1;106(9):1255-63. doi: 10.1016/j.amjcard.2010.06.051.

Drugs

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