Shahid Muhammed Siddique, Bourgleh Mariam Safwan, Alharfi Adel, Albariqi Shahad, Albalawi Lamia, Alohali Rema, Albaqami Turki, Bourgleh Moaz Safwan
From the Department of Clinical Sciences, College of Medicine, Sulaiman Al Rajhi University, Al Bukayriyah, Saudi Arabia.
From the Department of Clinical Sciences, College of Medicine, Tabuk University, Tabuk, Saudi Arabia.
Ann Saudi Med. 2025 Mar-Apr;45(2):112-128. doi: 10.5144/0256-4947.2025.112. Epub 2025 Apr 3.
Ischemic stroke (IS) is a leading cause of disability and mortality, with fatal outcomes increased with recurrent strokes. This systematic review and meta-analysis of randomized controlled trials (RCTs) evaluated the safety and efficacy of high-dose statins for secondary IS prevention.
This review was regestered on PROSPERO (registration number: CRD42024574088). Cochrane methodology was followed in this review and comprehensively searched PubMed, Embase, Cochrane Library and clinicaltrial.gov, to include all RCTs conducted from 2004 to 2024, comparing high-dose statins (simvastatin ≥40 mg, atorvastatin ≥40 mg, and rosuvastatin ≥20 mg) with low-dose statins, placebo, or standard care. Outcomes of this review were recurrent IS reduction and adverse events reported in RCTs.
Nine RCTs involving 5,503 patients, with male patients ranging from 25.8% to 81.6% were included. Compared to controls, high-dose statins did not significantly reduce risks for secondary IS (OR 0.78, 95% CI [0.61, 1.00], =.05) and hemorrhagic stroke (OR 0.85, 95% CI [0.56, 1.29], =.45). Furthermore, no differences were observed in mortality rates and adverse events between groups.
Treatment with high dose statins didn't reduce the risk of stroke recurrence or improve mortality, though further research is needed.
缺血性中风(IS)是导致残疾和死亡的主要原因,复发性中风会增加致命后果的风险。这项对随机对照试验(RCT)的系统评价和荟萃分析评估了大剂量他汀类药物用于二级预防缺血性中风的安全性和有效性。
本评价已在国际前瞻性系统评价注册库(PROSPERO)注册(注册号:CRD42024574088)。本评价遵循Cochrane方法,全面检索了PubMed、Embase、Cochrane图书馆和临床试验.gov,以纳入2004年至2024年进行的所有随机对照试验,比较大剂量他汀类药物(辛伐他汀≥40毫克、阿托伐他汀≥40毫克和瑞舒伐他汀≥20毫克)与小剂量他汀类药物、安慰剂或标准治疗。本评价的结果是随机对照试验中报告的复发性缺血性中风减少情况和不良事件。
纳入了9项随机对照试验,涉及5503名患者,男性患者比例在25.8%至81.6%之间。与对照组相比,大剂量他汀类药物并未显著降低二级缺血性中风的风险(比值比0.78,95%置信区间[0.61,1.00],P = 0.05)和出血性中风的风险(比值比0.85,95%置信区间[0.56,1.29],P = 0.45)。此外,两组之间在死亡率和不良事件方面未观察到差异。
大剂量他汀类药物治疗并未降低中风复发风险或改善死亡率,不过仍需要进一步研究。