Effects of ezetimibe/simvastatin 10/10 mg versus Rosuvastatin 10 mg on carotid atherosclerotic plaque inflammation

BMC Cardiovasc Disord. 2019 Aug 19;19(1):201. doi: 10.1186/s12872-019-1184-2.

Abstract

Background: Using 18F-fluorodeoxyglucose (18FDG) positron emission tomography-computed tomography (PET/CT) imaging, we examined the effects of ezetimibe/simvastatin 10/10 mg versus rosuvastatin 10 mg on carotid atherosclerotic plaque inflammation. Whether the combination therapy of ezetimibe with low-dose statin is as effective as potent statin monotherapy in attenuating carotid atherosclerotic plaque inflammation remains unclear.

Methods: In this 2-by-2 factorial trial, 50 patients with 18FDG uptake (target-to-background ratio [TBR] ≥1.6) in the carotid artery and acute coronary syndrome were randomized to receive either simvastatin/ezetimibe 10/10 mg or rosuvastatin 10 mg. 18FDG PET/CT examinations were performed at baseline and at 6 months. The percent change in the TBR of the index vessel at the most diseased segment (MDS) was the primary endpoint.

Results: Baseline characteristics of the two groups were largely similar. At 6-month follow-up, the MDS TBR of the index vessel and aorta significantly decreased in ezetimibe/simvastatin group and tended to decrease in rosuvastatin group. However, the percent change in the MDS TBR of the index vessel was similar between the 2 groups (- 10.22 ± 17.49% vs. -5.84 ± 15.78%, respectively, p = 0.357), as was the percent change in the whole vessel TBR of the index vessel. Likewise, the changes in the MDS TBR or whole vessel TBR of the aorta were similar in both groups. Total cholesterol and low-density lipoprotein cholesterol levels improved to a similar degree in both groups.

Conclusion: Treatment with ezetimibe/simvastatin versus rosuvastatin resulted in a similar improvement of carotid atherosclerotic plaque inflammation, suggesting their equivalent anti-inflammatory effects.

Trial registration: The trial is registered at ClinicalTrials.gov : NCT02378064, 3-4-2015. /IRB No. 2015-0194.

Keywords: Ezetimibe; Plaque inflammation; Positron emission tomography; Statin.

Publication types

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

MeSH terms

  • Aged
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Carotid Artery Diseases / diagnostic imaging
  • Carotid Artery Diseases / drug therapy*
  • Ezetimibe, Simvastatin Drug Combination / administration & dosage*
  • Ezetimibe, Simvastatin Drug Combination / adverse effects
  • Female
  • Fluorodeoxyglucose F18 / administration & dosage
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage*
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects
  • Inflammation / diagnostic imaging
  • Inflammation / drug therapy*
  • Male
  • Middle Aged
  • Plaque, Atherosclerotic*
  • Positron Emission Tomography Computed Tomography
  • Predictive Value of Tests
  • Radiopharmaceuticals / administration & dosage
  • Rosuvastatin Calcium / administration & dosage*
  • Rosuvastatin Calcium / adverse effects
  • Seoul
  • Time Factors
  • Treatment Outcome

Substances

  • Anti-Inflammatory Agents
  • Ezetimibe, Simvastatin Drug Combination
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Radiopharmaceuticals
  • Fluorodeoxyglucose F18
  • Rosuvastatin Calcium

Associated data

  • ClinicalTrials.gov/NCT02378064