Comparison of High-Dose Rosuvastatin Versus Low-Dose Rosuvastatin Plus Ezetimibe on Carotid Atherosclerotic Plaque Inflammation in Patients with Acute Coronary Syndrome

J Cardiovasc Transl Res. 2020 Dec;13(6):900-907. doi: 10.1007/s12265-020-10009-4. Epub 2020 May 4.

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

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Coronary Syndrome / diagnostic imaging
  • Acute Coronary Syndrome / drug therapy*
  • Aged
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Anticholesteremic Agents / administration & dosage*
  • Anticholesteremic Agents / adverse effects
  • Carotid Artery Diseases / diagnostic imaging
  • Carotid Artery Diseases / drug therapy*
  • Drug Combinations
  • Ezetimibe / administration & dosage*
  • Ezetimibe / adverse effects
  • Female
  • Fluorodeoxyglucose F18 / administration & dosage
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage*
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects
  • Male
  • Middle Aged
  • Plaque, Atherosclerotic*
  • Positron Emission Tomography Computed Tomography
  • Prospective Studies
  • Radiopharmaceuticals / administration & dosage
  • Rosuvastatin Calcium / administration & dosage*
  • Rosuvastatin Calcium / adverse effects
  • Seoul
  • Time Factors
  • Treatment Outcome

Substances

  • Anti-Inflammatory Agents
  • Anticholesteremic Agents
  • Drug Combinations
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Radiopharmaceuticals
  • Fluorodeoxyglucose F18
  • Rosuvastatin Calcium
  • Ezetimibe