Effects of Ezetimibe-Statin Combination Therapy on Coronary Atherosclerosis in Acute Coronary Syndrome
Kiyoshi Hibi, Shinjo Sonoda, Masanori Kawasaki, Yutaka Otsuji, Toyoaki Murohara, Hideki Ishii, Katsuhiko Sato, Ryoji Koshida, Yukio Ozaki, Masataka Sata, Yoshihiro Morino, Tadashi Miyamoto, Tetsuya Amano, Satoshi Morita, Ken Kozuma, Kazuo Kimura, Hisayoshi Fujiwara, Ezetimibe-ACS Investigators, Kiyoshi Hibi, Shinjo Sonoda, Masanori Kawasaki, Yutaka Otsuji, Toyoaki Murohara, Hideki Ishii, Katsuhiko Sato, Ryoji Koshida, Yukio Ozaki, Masataka Sata, Yoshihiro Morino, Tadashi Miyamoto, Tetsuya Amano, Satoshi Morita, Ken Kozuma, Kazuo Kimura, Hisayoshi Fujiwara, Ezetimibe-ACS Investigators
Abstract
Background: The results of previous clinical trials on the effects of ezetimibe-statin combination therapy on atherosclerosis are inconsistent, and the anti-atherosclerotic effect of ezetimibe remains controversial.Methods and Results:We conducted a prospective, randomized open-label study at 10 centers. One hundred and twenty-eight statin-naïve patients with acute coronary syndrome (ACS) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention were randomized to receive either 2 mg/day pitavastatin plus 10 mg/day ezetimibe, or 2 mg/day pitavastatin. One hundred and 3 patients had evaluable IVUS of non-culprit coronary lesions at baseline and at follow-up. The primary endpoint was the percentage change in non-culprit coronary plaque volume (PV) and lipid PV on integrated backscatter IVUS. Mean low-density lipoprotein cholesterol was reduced from 123 mg/dL to 64 mg/dL in the combination therapy group (n=50) and 126 mg/dL to 87 mg/dL in the statin alone group (n=53; between-group difference, 16.9%, P<0.0001). The percent change in PV was -5.1% in the combination therapy group and -6.2% in the statin alone group (P=0.66), although both groups had reduction of PV compared with baseline (both P<0.01). The percent change in lipid PV did not differ between the groups (4.3 vs. -3.0%, P=0.37).
Conclusions: In statin-naïve patients with ACS, combined therapy with ezetimibe and statin did not result in a significant change in coronary plaque regression or tissue component compared with statin alone. [Clinical Trial Registration: www.clinicaltrials.gov (NCT00549926)].
Keywords: Acute coronary syndrome; Intravascular ultrasound; Lipid-lowering therapy; Low-density lipoprotein cholesterol.
Source: PubMed