阿托伐他汀(10mg)和依折麦布(10mg)联合治疗与阿托伐他汀(40mg)单独治疗对冠状动脉粥样硬化的影响。
Effect of Atorvastatin (10 mg) and Ezetimibe (10 mg) Combination Compared to Atorvastatin (40 mg) Alone on Coronary Atherosclerosis.
机构信息
Department of Cardiology, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.
Department of Cardiology, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.
出版信息
Am J Cardiol. 2021 Sep 1;154:22-28. doi: 10.1016/j.amjcard.2021.05.039. Epub 2021 Jul 6.
It remains inconclusive whether the additional low-density lipoprotein cholesterol (LDL-C) lowering effects of ezetimibe added to statin on coronary atherosclerosis and clinical outcomes are similar to those of statin monotherapy in the setting of comparable LDL-C reduction. We aimed to determine whether there were distinguishable differences in their effects on coronary atherosclerosis with intermediate stenosis between the combination of moderate-intensity statin plus ezetimibe and high-intensity statin monotherapy. Forty-one patients with stable angina undergoing percutaneous coronary intervention were randomized to receive either atorvastatin 10 mg plus ezetimibe 10 mg (ATO10/EZE10) or atorvastatin 40 mg alone (ATO40). The intermediate lesions were evaluated using a near-infrared spectroscopy-intravascular ultrasonography at baseline and after 12 months in 37 patients. The primary endpoint was percent atheroma volume (PAV). Mean LDL-C levels were significantly reduced by 40% and 38% from baseline in the ATO10/EZE10 group (n = 18, from 107 mg/dL to 61 mg/dL) and ATO40 group (n = 19, from 101 mg/dL to 58 mg/dL), respectively, without between-group difference. The absolute change of PAV was -2.9% in the ATO10/EZE10 group and -3.2% in the ATO40 group. The mean difference (95% confidence interval) for the absolute change in PAV between the 2 groups was 0.5% (-2.4% to 2.8%), which did not exceed the pre-defined non-inferiority margin of 5%. There was no significant reduction in lipid core burden index in both groups. In conclusion, the combination of atorvastatin 10 mg and ezetimibe 10 mg showed comparable LDL-C lowering and regression of coronary atherosclerosis in the intermediate lesions, compared with atorvastatin 40 mg alone.
依折麦布联合中等强度他汀与高强度他汀单药治疗对中等狭窄程度冠状动脉粥样硬化的影响是否存在差异
在 LDL-C 降幅相当的情况下,依折麦布联合他汀类药物进一步降低 LDL-C 对冠状动脉粥样硬化及临床结局的影响尚不明确。我们旨在明确中等强度他汀类药物联合依折麦布与高强度他汀类药物单药治疗在中等狭窄程度病变患者中对冠状动脉粥样硬化的影响是否存在差异。41 例行经皮冠状动脉介入治疗的稳定性心绞痛患者随机分为阿托伐他汀 10mg 联合依折麦布 10mg(ATO10/EZE10 组)或阿托伐他汀 40mg 单药治疗(ATO40 组)。37 例患者在基线及治疗 12 个月时分别采用近红外光谱血管内超声评估中间病变。主要终点为动脉粥样斑块体积百分比(PAV)。ATO10/EZE10 组(n=18)和 ATO40 组(n=19)患者的 LDL-C 水平分别较基线时降低 40%和 38%(分别从 107mg/dL 降至 61mg/dL 和从 101mg/dL 降至 58mg/dL),两组间差异无统计学意义。ATO10/EZE10 组和 ATO40 组的 PAV 绝对值变化分别为-2.9%和-3.2%。两组间 PAV 绝对值变化的平均差值(95%置信区间)为 0.5%(-2.4%至 2.8%),未超过预先设定的非劣效性边界 5%。两组患者的脂质核心负荷指数均无显著降低。结论:与阿托伐他汀 40mg 单药治疗相比,阿托伐他汀 10mg 联合依折麦布 10mg 可进一步降低 LDL-C,中等狭窄程度病变的冠状动脉粥样硬化也出现了相似程度的消退。