Efficacy and safety of lipid-lowering therapies in combination with or without statin to reduce the cardiovascular risk: A systematic review of randomised controlled trials

IF 1.4 Q3 PERIPHERAL VASCULAR DISEASE Atherosclerosis plus Pub Date : 2024-10-17 DOI:10.1016/j.athplu.2024.10.001
Gabriella Iannuzzo , Geetank Kamboj , Parinita Barman , Shirish Dongare , Shantanu Jawla
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Abstract

Background and aims

Cardiovascular diseases (CVD) pose a significant global health burden. Lowering low-density lipoprotein-cholesterol is the primary therapeutic aim for preventing primary and secondary CVD events. While statins are the standard treatments, their limitations, such as side effects and intolerance in certain patient groups, necessitate exploration of alternative lipid-lowering therapies (LLTs). We systematically reviewed randomised controlled trials (RCTs) evaluating cardiovascular outcomes associated with non-statin LLTs (bempedoic acid, alirocumab, evolocumab, ezetimibe, and inclisiran) in adults with CVD or high cardiovascular risk.

Methods

EMBASE, Medline, Cochrane Library, and clinical trial registries were systematically searched for eligible studies, from inception until February 08, 2023. Two reviewers independently screened the studies, with discrepancies resolved by a third reviewer. Data extraction and validation were conducted, and the risk of bias was assessed using the Cochrane Risk-of-Bias tool-2 for RCTs.

Results

The search strategy yielded 2104 citations. Post screening for eligibility, nine unique trials/studies (84 publications) were identified. Among these, one trial each was identified for bempedoic acid and alirocumab, three for evolocumab, and four for ezetimibe. No published literature documenting the cardiovascular outcomes of inclisiran was identified. Only one trial (CLEAR Outcomes) included statin-intolerant patients at baseline. Most studies evaluated a 3-component, 4-component, or 5-component major adverse cardiovascular events composite as an outcome along with individual components. The quality of the included trials was found to be fair-to-good.

Conclusions

The systematic review findings emphasise the significance of considering non-statin LLTs as viable treatment options for individuals with CVD or high cardiovascular risk who cannot tolerate or achieve optimal lipid control with statin therapy alone.

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降脂疗法联合或不联合他汀类药物降低心血管风险的有效性和安全性:随机对照试验的系统回顾
背景和目的心血管疾病(CVD)给全球健康造成了巨大负担。降低低密度脂蛋白胆固醇是预防原发性和继发性心血管疾病的主要治疗目标。虽然他汀类药物是标准疗法,但由于其副作用和某些患者群体的不耐受性等局限性,有必要探索其他降脂疗法(LLTs)。我们系统地回顾了评估非白金类 LLTs(贝美多酸、阿利曲库单抗、依维莫单抗、依泽替米贝和 inclisiran)对患有心血管疾病或心血管风险较高的成人的心血管预后的随机对照试验(RCT)。两名审稿人独立筛选研究,不一致之处由第三名审稿人解决。进行了数据提取和验证,并使用针对 RCT 的 Cochrane Risk-of-Bias 工具-2 评估了偏倚风险。经过资格筛选,确定了 9 项独特的试验/研究(84 篇出版物)。其中,贝美多克酸和阿利曲库单抗各确定了一项试验,依维莫司确定了三项试验,依泽替米贝确定了四项试验。未发现记录 inclisiran 心血管疗效的已发表文献。只有一项试验(CLEAR Outcomes)纳入了基线时不耐受他汀类药物的患者。大多数研究评估了由 3 个部分、4 个部分或 5 个部分组成的主要心血管不良事件复合结果以及单个部分。结论系统综述结果强调,对于不能耐受或不能通过他汀治疗达到最佳血脂控制效果的心血管疾病患者或高心血管风险患者,考虑将非他汀类 LLTs 作为可行的治疗方案具有重要意义。
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来源期刊
Atherosclerosis plus
Atherosclerosis plus Cardiology and Cardiovascular Medicine
CiteScore
2.60
自引率
0.00%
发文量
0
审稿时长
66 days
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