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

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.