Dose-comparison study of the combination of ezetimibe and simvastatin (Vytorin) versus atorvastatin in patients with hypercholesterolemia: the Vytorin Versus Atorvastatin (VYVA) study.

Abstract

BACKGROUND:

Low-density lipoprotein cholesterol (LDL-C) is the primary therapeutic target in the National Cholesterol Education Program Adult Treatment Panel III (ATP III) guidelines. This study tested the hypothesis that ezetimibe/simvastatin, a lipid-lowering agent that inhibits both intestinal cholesterol absorption and cholesterol synthesis, provides greater LDL-C reductions than atorvastatin across dose ranges.

METHODS:

This multicenter, double-blind, 6-week parallel-group study randomized 1902 patients with LDL-C above ATP III goal to atorvastatin (10, 20, 40, or 80 mg) or to ezetimibe/simvastatin (10/10, 10/20, 10/40, or 10/80 mg). Patients were stratified by prerandomization LDL-C level.

RESULTS:

At each milligram-equivalent statin dose comparison, and averaged across doses, ezetimibe/simvastatin provided greater LDL-C reductions (47%-59%) than atorvastatin (36%-53%). Ezetimibe/simvastatin 10/40 and 10/80 mg also provided significantly greater high-density lipoprotein cholesterol (HDL-C) increases than atorvastatin 40 and 80 mg. Triglyceride reductions were similar for all comparisons. More ezetimibe/simvastatin than atorvastatin patients with coronary heart disease (CHD) or CHD risk equivalents attained the ATP III LDL-C goal of <100 mg/dL and the optional LDL-C target of <70 mg/dL. C-reactive protein reductions were similar between treatment groups. Consecutive elevations in alanine aminotransferase and/or aspartate aminotransferase occurred in significantly more atorvastatin patients than ezetimibe/simvastatin patients. No myopathy or liver-related adverse events led to study discontinuation with either drug.

CONCLUSIONS:

Ezetimibe/simvastatin was more effective than atorvastatin in lowering LDL-C at each dose comparison and provided greater increases in HDL-C at the 40- and 80-mg statin dose. Ezetimibe/simvastatin is a highly efficacious, well-tolerated treatment option for hypercholesterolemic patients.

• Authors: Christie M Ballantyne, Nicola Abate, Zhong Yuan, Thomas R King, Joanne Palmisano
• Journal: American heart journal (Am Heart J) Vol. 149 Issue 3 Pg. 464-73 (Mar 2005) ISSN: 1097-6744 [Electronic] United States
• PMID: 15864235 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anticholesteremic Agents
• Azetidines
• Cholesterol, HDL
• Cholesterol, LDL
• C-Reactive Protein
• Simvastatin
• Ezetimibe

Topics

• Adult
• Aged
• Anticholesteremic Agents (administration & dosage)
• Azetidines (administration & dosage)
• C-Reactive Protein (drug effects, metabolism)
• Cholesterol, HDL (drug effects, metabolism)
• Cholesterol, LDL (drug effects, metabolism)
• Double-Blind Method
• Drug Therapy, Combination
• Ezetimibe
• Female
• Humans
• Hypercholesterolemia (drug therapy, metabolism)
• Male
• Middle Aged
• Simvastatin (administration & dosage)