Abstract
The low-density lipoprotein cholesterol (LDL-C) lowering efficacy of switching to ezetimibe/simvastatin (EZ/S) 10/20 mg versus doubling the run-in statin dose (to simvastatin 40 mg or atorvastatin 20 mg) or switching to rosuvastatin 10 mg in subjects with cardiovascular disease (CVD) and diabetes was assessed. Endpoints included percentage change in LDL-C and percentage of patients achieving LDL-C <70 mg/dL. Significantly greater reductions in LDL-C occurred when switching to EZ/S versus statin doubling in the overall population and in subjects treated with simvastatin 20 mg or atorvastatin 10 mg (all p < 0.001). The LDL-C reduction was numerically greater when switching to EZ/S versus switching to rosuvastatin (p = 0.060). Significantly more subjects reached LDL-C <70 mg/dL with EZ/S (54.5%) versus statin doubling (27.0%) or rosuvastatin (42.5%) in the overall population (all p < 0.001) and within each stratum (all p < 0.001). Switching to EZ/S provided significantly greater reductions in LDL-C versus statin doubling and significantly greater achievement of LDL-C targets versus statin doubling or switching to rosuvastatin.
Trial registration:
ClinicalTrials.gov NCT00862251.
Publication types
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Comparative Study
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Aged
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Aged, 80 and over
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Anticholesteremic Agents / administration & dosage
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Anticholesteremic Agents / adverse effects
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Anticholesteremic Agents / therapeutic use*
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Atorvastatin
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Azetidines / adverse effects
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Azetidines / therapeutic use*
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Cardiovascular Diseases / etiology
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Cardiovascular Diseases / prevention & control*
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Cholesterol, LDL / blood*
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Diabetes Complications / blood
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Diabetes Complications / drug therapy*
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Diabetes Complications / physiopathology
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Diabetic Angiopathies / etiology
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Diabetic Angiopathies / prevention & control*
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Double-Blind Method
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Drug Combinations
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Drug Monitoring
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Ezetimibe, Simvastatin Drug Combination
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Female
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Fluorobenzenes / adverse effects
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Fluorobenzenes / therapeutic use
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Heptanoic Acids / administration & dosage
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Heptanoic Acids / adverse effects
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Heptanoic Acids / therapeutic use
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Humans
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Hypercholesterolemia / blood
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Hypercholesterolemia / complications
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Hypercholesterolemia / drug therapy*
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Hypercholesterolemia / physiopathology
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Longitudinal Studies
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Male
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Middle Aged
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Pyrimidines / adverse effects
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Pyrimidines / therapeutic use
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Pyrroles / administration & dosage
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Pyrroles / adverse effects
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Pyrroles / therapeutic use
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Rosuvastatin Calcium
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Severity of Illness Index
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Simvastatin / administration & dosage
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Simvastatin / adverse effects
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Simvastatin / therapeutic use*
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Sulfonamides / adverse effects
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Sulfonamides / therapeutic use
Substances
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Anticholesteremic Agents
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Azetidines
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Cholesterol, LDL
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Drug Combinations
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Ezetimibe, Simvastatin Drug Combination
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Fluorobenzenes
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Heptanoic Acids
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Pyrimidines
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Pyrroles
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Sulfonamides
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Rosuvastatin Calcium
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Atorvastatin
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Simvastatin
Associated data
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ClinicalTrials.gov/NCT00862251