2022 台灣版高血脂治療指引-針對心血管疾病高風險族群 2 ACS/CAD STATIN 亞洲新證據

2025-12-09 14:10
2022 focused update of the 2017 Taiwanlipid guidelines for high risk patients:Coronary artery disease, peripheral arterydisease and ischemic stroke

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亞洲最新他汀類藥物數據

2017年台灣高風險病患血脂指引建議冠心病/急性冠狀動脈症候群（CAD/ACS）病患的低密度脂蛋白膽固醇（LDL-C）目標值為70 mg/dL。近期在日本進行的大型隨機臨床試驗REAL-CAD研究證實，將亞洲冠心病患者的LDL-C降低至70 mg/dL左右具有益處。 ⁵ 研究納入了符合以下條件的穩定性冠心病患者：（1）有急性冠脈綜合徵病史，包括急性心肌梗塞（MI）或不穩定型心絞痛超過3個月；（2）既往接受過冠狀動脈血運重建術，包括經皮冠狀動脈介入治療或冠狀動脈旁路移植術超過3個月；這些患者被隨機分配至高劑量（4 mg/天）或低劑量（1 mg/天）匹伐他汀治療組。主要終點為複合終點，包括心血管死亡、非致死性心肌梗塞、非致死性缺血性中風或需要緊急住院治療的不穩定型心絞痛。接受強化他汀治療以使低密度脂蛋白膽固醇（LDL-C）水平達到約 73 mg/dL 的患者，其 4 年累積主要終點事件發生率顯著低於接受強度較低的他汀治療以使 LDL-C 水平達到約 90 mg/dL 的患者。 ⁵ 這項試驗是首個在亞洲進行的試驗，結果表明，使用高劑量他汀類藥物積極降低 LDL-C 水平不僅有益，而且在亞洲人群中耐受性良好。

ACS/CAD

New statin data in Asia

In the 2017 Taiwan Lipid Guidelines for High Risk Patients, the recommended target of low-density lipoprotein cholesterol (LDL-C) for patients with CAD/ACS is 70 mg/dL. The benefit of lowering down LDL-C to around 70 mg/dL for Asian CAD patients was recently proved in the REAL-CAD study, a large-scale randomized clinical trial performed in Japan.5 The study included stable CAD patients with (1) history of ACS, including acute myocardial infarction (MI) or unstable angina >3 months, or (2) previous coronary revascularization, including percutaneous coronary intervention or coronary artery bypass graft >3 months, or (3) angiographically documented coronary artery stenosis of at least 75% diameter stenosis. These patients were randomized to high dose (4 mg/day) or low dose (1 mg/day) pitavastatin therapy. The primary outcome was a composite end point of cardiovascular death, nonfatal MI, nonfatal ischemic stroke, or unstable angina requiring emergency hospitalization. The cumulative 4-year incidence of the primary outcome events was significantly lower in patients treated with intensive statin therapy to achieve an LDL-C level around 73 mg/dL compared to those with less intensive statin therapy with an LDL-C level around 90 mg/dL.5 This trial was the first one performed in Asia and demonstrated that aggressive LDL-C lowering with high dose statin is not only beneficial but also well tolerated in Asian population.