2022 focused update of the 2017 Taiwanlipid guidelines for high risk patients:Coronary artery disease, peripheral arterydisease and ischemic stroke
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除他汀類藥物以外的其他降低低密度脂蛋白膽固醇（LDL-C）的藥物
一項包含 6 項隨機臨床試驗的統合分析表明，與他汀類藥物單藥治療相比，依折麥布聯合他汀類藥物治療可降低非致命性中風的風險（風險比 [RR] 0.83，95% CI 0.71e0.97）。 42TST 試驗顯示，在 LDL-C < 70 mg/dL 的強化 LDL-C 降低組中，41% 的患者接受了依折麥布聯合治療；而在LDL-C介於90至110 mg/dL的患者組中，僅有7%的患者接受了依折麥布治療。 IMPROVE-IT試驗也顯示，與單獨使用辛伐他汀相比，依折麥布合併辛伐他汀可降低ACS合併既往中風史患者發生任何病因中風（HR 0.60，95% CI 0.38-0.95）和缺血性中風（HR 0.52，95% CI 0.0.6%）的風險。 在IMPROVE-IT試驗中，LDL-C < 30 mg/dL的患者與LDL-C ≥ 70 mg/dL的患者相比，出血性中風的風險並未增加。 PCSK9抑制劑也證實了其在預防中風方面的療效。在 FOURIER 試驗中，使用 evolocumab 治療穩定的 ASCVD 患者，與他汀類藥物單藥治療相比，evolocumab 聯合他汀類藥物顯著降低了所有卒中（HR 0.79，95% CI，0.66e0.95）和缺血性卒中（HR 0.75，95% CI 20.95% CI 20.909）。 45 出血性中風方面沒有顯著差異（HR 1.16，95% CI 0.68e1.98）。在有無既往缺血性中風的各組中，此效應均一致。 45 在 ODYSSEY OUTCOMES 試驗中，使用阿利西尤單抗治療近期發生 ACS 的患者，阿利西尤單抗降低了任何中風的風險（HR 0.72，95% CI 0.57-0.91）和缺血性中風的風險（HR 0.73，95% CI 0.577.5757）。 46 出血性中風的風險並未增加（HR 0.83，95% CI 0.42-1.65）。同樣，阿利西尤單抗對卒中的影響在有卒中史和無卒中史的患者中相似。一項包含39篇隨機對照試驗的統合分析顯示，PCSK9抑制劑（阿利西尤單抗或依洛尤單抗）與他汀類藥物合併治療可降低缺血性中風的風險（RR 0.78，95% CI 0.67-0.89）。 <sup>47</sup>
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對於患有缺血性中風或 TIA 以及腦動脈粥樣硬化性狹窄或已知 CAD 的患者，將他汀類藥物與依折麥布聯合使用以達到 LDL-C < 70 mg/dL 是合理的（COR IIa，LOE B）。
對於患有缺血性中風或 TIA 以及腦動脈粥樣硬化性狹窄或已知 CAD 的患者，如果在聯合使用最大耐受劑量的他汀類藥物和依折麥布的情況下 LDL-C > 70 mg/dL，則添加 PCSK9 抑製劑是合理的（LOR IIa，LOE B）。
LDL-C lowering agents other than statins
A meta-analysis of 6 randomized clinical trials suggested that ezetimibe added to statins compared to statins monotherapy was associated with a lower risk of nonfatal stroke (risk ratio [RR] 0.83, 95% CI 0.71e0.97).42The TST trial showed that 41% of patients assigned to the intensive LDL-C lowering group with LDL-C < 70 mg/dL received ezetimibe combination therapy; whereas only 7% of patients received ezetimibe in the group with LDL-C between 90 and 110 mg/dL.4 The IMPROVE-IT trial also showed that combined ezetimibe with simvastatin compared with simvastatin alone reduced the risk of stroke of any etiology (HR 0.60, 95% CI 0.38e0.95) and ischemic stroke (HR, 0.52, 95% CI, 0.31e0.86) among patients with ACS and a prior history of stroke.43 In the IMPROVE-IT trial, the risk of hemorrhagic stroke was not increased in patients with LDLC < 30 mg/dL compared to those with LDL-C 70 mg/dL.44 PCSK9 inhibitors also demonstrated their efficacy in preventing stroke. In the FOURIER trial using evolocumab for stable ASCVD patients, evolocumab plus statin significantly reduced all stroke (HR 0.79, 95% CI, 0.66e0.95) and ischemic stroke (HR 0.75, 95% CI 0.62e0.92) compared with statin monotherapy.45 There was no significant difference in hemorrhagic stroke (HR 1.16, 95% CI 0.68e1.98). The effect was consistent across among the groups with and without prior ischemic stroke.45 In the ODYSSEY OUTCOMES trial using alirocumab for patients with recent ACS, alirocumab reduced the risk of any stroke (HR 0.72, 95% CI 0.57e0.91) and ischemic stroke (HR, 0.73, 95% CI, 0.57e0.93).46 There was no increased risk of hemorrhagic stroke (HR 0.83, 95% CI 0.42e1.65). Similarly, the effect of alirocumab on stroke was similar between patients with and without a history of previous stroke.46 A meta-analysis of 39 randomized controlled trials showed that combination therapy of PCSK9 inhibitors (alirocumab or evolocumab) with statins were associated with a reduced risk of ischemic stroke (RR 0.78, 95% CI 0.67e0.89).47
Recommendation
In patients with ischemic stroke or TIA and cerebral or carotid atherosclerotic stenosis or known CAD, it is reasonable to combine statin with ezetimibe to achieve LDL-C < 70 mg/dL (COR IIa, LOE B).
In patients with ischemic stroke or TIA and cerebral or carotid atherosclerotic stenosis or known CAD, adding a PCSK9 inhibitor is reasonable if LDL-C > 70 mg/dL under combined maximally tolerated statins plus ezetimibe (LOR IIa, LOE B).
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