Department of Cardiovascular Medicine, Graduate School of Medical Sciences, and Center for Metabolic Regulation of Healthy Aging (CMHA), Kumamoto University.
Department of Cardiovascular Medicine, Fukuoka Tokushukai Medical Center.
J Atheroscler Thromb. 2022 Feb 1;29(2):229-241. doi: 10.5551/jat.59477. Epub 2021 Jan 7.
Matrix metalloproteinases (MMPs) play critical roles in acute myocardial infarction (AMI). This trial was conducted to determine the potential effects of higher-dose rosuvastatin on circulating MMP levels in patients with AMI.
This was a multicenter, open-label, 1:1 randomized, parallel-group study. Patients with AMI were randomly assigned to the appropriate-dose group (10 mg rosuvastatin once daily) or the low-dose group (2.5 mg rosuvastatin once daily) within 24 hours after percutaneous coronary intervention. MMP-2 and MMP-9 levels were measured on day 1 and at week 4, 12, and 24 after enrollment. The primary endpoint was the change in MMP levels at 24 weeks after enrollment. The secondary endpoints were change in MMP levels at day 1 and weeks 4 and 12 after enrollment.
Between August 2017 and October 2018, 120 patients with AMI from 19 institutions were randomly assigned to either the appropriate-dose or the low-dose group. There were 109 patients who completed the 24-week follow-up. The primary endpoint for both MMP-2 and MMP-9 was not significantly different between the two groups. The change in the active/total ratio of MMP-9 at week 12 after baseline was significantly lower in the appropriate-dose group compared with the low-dose group (0.81 [-52.8-60.1]% vs. 70.1 [-14.5-214.2]%, P=0.004), while the changes in MMP-2 were not significantly different between the two groups during the study period.
This study could not demonstrate the superiority of appropriate-dose of rosuvastatin in inhibiting serum MMPs levels in patients with AMI.
基质金属蛋白酶（MMPs）在急性心肌梗死（AMI）中发挥关键作用。本试验旨在确定较高剂量瑞舒伐他汀对 AMI 患者循环 MMP 水平的潜在影响。
这是一项多中心、开放标签、1:1 随机、平行组研究。AMI 患者在经皮冠状动脉介入治疗后 24 小时内被随机分配至适当剂量组（每天 10 mg 瑞舒伐他汀）或低剂量组（每天 2.5 mg 瑞舒伐他汀）。在入组后第 1 天和第 4、12、24 周测量 MMP-2 和 MMP-9 水平。主要终点为入组后 24 周时 MMP 水平的变化。次要终点为入组后第 1 天、第 4 周和第 12 周时 MMP 水平的变化。
2017 年 8 月至 2018 年 10 月，来自 19 家机构的 120 例 AMI 患者被随机分配至适当剂量组或低剂量组。有 109 例患者完成了 24 周的随访。两组 MMP-2 和 MMP-9 的主要终点均无显著差异。与低剂量组相比，适当剂量组基线后第 12 周 MMP-9 活性/总比值的变化明显更低（0.81 [-52.8-60.1]% vs. 70.1 [-14.5-214.2]%，P=0.004），而在研究期间两组 MMP-2 的变化无显著差异。
本研究未能证明适当剂量瑞舒伐他汀在抑制 AMI 患者血清 MMP 水平方面具有优越性。
