Masuda Jun, Tanigawa Takashi, Yamada Tomomi, Nishimura Yuki, Sasou Takashi, Nakata Tomoyuki, Sawai Toshiki, Fujimoto Naoki, Dohi Kaoru, Miyahara Masatoshi, Nishikawa Masakatsu, Nakamura Mashio, Ito Masaaki
Department of Cardiology and Nephrology, Mie University Graduate School of Medicine.
Int Heart J. 2015 May 13;56(3):278-85. doi: 10.1536/ihj.14-311. Epub 2015 Apr 23.
Ezetimibe has been reported to provide significant incremental reduction in low-density-lipoprotein cholesterol (LDL-C) when added to a statin; however, its effect on coronary atherosclerosis has not yet been evaluated in detail. The aim of this study was to investigate the add-on effect of ezetimibe to a statin on coronary atherosclerosis evaluated by intravascular ultrasound (IVUS).In this prospective randomized open-label study, a total of 51 patients with stable coronary artery disease (CAD) requiring percutaneous coronary intervention (PCI) were enrolled, and assigned to a combination group (n = 26, rosuvastatin 5 mg/day + ezetimibe 10 mg/day) or a monotherapy group (n = 25, rosuvastatin 5 mg/day). Volumetric IVUS analyses were performed at baseline and 6 months after the treatment for a non-PCI site. LDL-C level was significantly reduced in the combination group (-55.8%) versus that in the monotherapy group (-36.8%; P = 0.004). The percent change in plaque volume (PV), the primary endpoint, appeared to decrease more effectively in the combination group compared with the monotherapy group (-13.2% versus -3.1%, respectively, P = 0.050). Moreover, there was a significant group × time interaction in the effects of the two treatments on PV (P = 0.021), indicating the regressive effect of the combination therapy on PV was greater than that of monotherapy for subtly different values of baseline PV in the two treatment groups. Moreover, percent change in PV showed positive correlations with percent change of LDL-C (r = 0.384, P = 0.015).Intensive lipid-lowering therapy with ezetimibe added to usual-dose statin may provide significant incremental reduction in coronary plaques compared with usual-dose statin monotherapy.
据报道，依折麦布与他汀类药物联用时，能显著进一步降低低密度脂蛋白胆固醇（LDL-C）水平；然而，其对冠状动脉粥样硬化的影响尚未得到详细评估。本研究旨在通过血管内超声（IVUS）研究依折麦布与他汀类药物联用对冠状动脉粥样硬化的附加作用。在这项前瞻性随机开放标签研究中，共纳入51例需要接受经皮冠状动脉介入治疗（PCI）的稳定型冠心病（CAD）患者，并将其分为联合治疗组（n = 26，瑞舒伐他汀5毫克/天 + 依折麦布10毫克/天）或单药治疗组（n = 25，瑞舒伐他汀5毫克/天）。在基线时以及治疗6个月后，对一个非PCI部位进行血管内超声容积分析。联合治疗组的LDL-C水平显著降低（-55.8%），而单药治疗组为（-36.8%；P = 0.004）。作为主要终点的斑块体积（PV）百分比变化，联合治疗组似乎比单药治疗组降低得更有效（分别为-13.2%和-3.1%，P = 0.050）。此外，两种治疗对PV的影响存在显著的组×时间交互作用（P = 0.021），表明联合治疗对PV的消退作用大于单药治疗，这是因为两个治疗组的基线PV值略有不同。此外，PV百分比变化与LDL-C百分比变化呈正相关（r = 0.384，P = 0.015）。与常规剂量他汀类药物单药治疗相比，常规剂量他汀类药物联合依折麦布进行强化降脂治疗可能会显著进一步减少冠状动脉斑块。
