Abstract
We compared the effects of ezetimibe/rosuvastatin 10/5 mg versus rosuvastatin 20 mg on carotid atherosclerotic plaque inflammation measured by 18FDG PET/CT. Fifty patients with acute coronary syndrome (ACS) were randomly assigned to the ezetimibe/rosuvastatin 10/5 mg and rosuvastatin 20 mg groups. The primary outcome was the percent change in the target-to-background ratio (TBR) of the index vessel in the most diseased segment (MDS), as assessed by 18FDG PET/CT at baseline and at 6 months. Forty-eight patients completed follow-up PET/CT. MDS TBR was - 6.2 ± 13.9% for patients in the ezetimibe/rosuvastatin group and - 10.8 ± 17.7% for those in the rosuvastatin group (difference, 4.6 percentage points; upper limitation of one-sided confidence interval = 13.8; p = 0.60 for noninferiority). In conclusion, combination therapy with ezetimibe 10 mg and rosuvastatin 5 mg compared with rosuvastatin 20 mg did not meet the criterion for non-inferiority for primary outcome, and the present study was not conclusive on whether the former was non-inferior to the latter. Graphical Abstract.
Keywords:
Ezetimibe; Plaque inflammation; Positron emission tomography; Statin.
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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Acute Coronary Syndrome / diagnostic imaging
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Acute Coronary Syndrome / drug therapy*
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Aged
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Anti-Inflammatory Agents / administration & dosage*
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Anti-Inflammatory Agents / adverse effects
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Anticholesteremic Agents / administration & dosage*
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Anticholesteremic Agents / adverse effects
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Carotid Artery Diseases / diagnostic imaging
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Carotid Artery Diseases / drug therapy*
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Drug Combinations
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Ezetimibe / administration & dosage*
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Ezetimibe / adverse effects
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Female
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Fluorodeoxyglucose F18 / administration & dosage
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Humans
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Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage*
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Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects
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Male
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Middle Aged
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Plaque, Atherosclerotic*
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Positron Emission Tomography Computed Tomography
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Prospective Studies
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Radiopharmaceuticals / administration & dosage
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Rosuvastatin Calcium / administration & dosage*
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Rosuvastatin Calcium / adverse effects
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Seoul
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Time Factors
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Treatment Outcome
Substances
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Anti-Inflammatory Agents
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Anticholesteremic Agents
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Drug Combinations
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Hydroxymethylglutaryl-CoA Reductase Inhibitors
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Radiopharmaceuticals
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Fluorodeoxyglucose F18
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Rosuvastatin Calcium
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Ezetimibe