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inclisiran对动脉粥样硬化性心血管疾病(ASCVD)患者低密度脂蛋白(LDL)的疗效和安全性:随机对照试验的系统评价

The Efficacy and Safety of Inclisiran for Low-Density Lipoprotein (LDL) in Patients With Atherosclerotic Cardiovascular Disease (ASCVD): A Systematic Review of Randomized Controlled Trials.

作者信息

Mirghani Hyder, Albalawi Bandar H, Alshehri Mohammed S, Almalawi Waseem M, Alanezi Sumaya, Alarki Mahmoud, Alyahya Abdullah A, Alshaman Sultan, Shaman Mariam S, AlAnazi Abeer

机构信息

Internal Medicine, University of Tabuk, Tabuk, SAU.

Surgery, King Khalid Hospital, Tabuk, SAU.

出版信息

Cureus. 2024 Sep 28;16(9):e70411. doi: 10.7759/cureus.70411. eCollection 2024 Sep.

Abstract

This systematic review synthesizes current evidence to evaluate the safety and efficacy of inclisiran for lowering low-density lipoprotein cholesterol (LDL-C). A thorough search was conducted across four main databases - PubMed, Web of Science, SCOPUS, and Science Direct - for relevant studies published in the literature within the last five years (2020-2024). We included seven studies with a total of 6831 participants, of which 4661 (68.2%) were males. The follow-up duration ranged from 60 to 1350 days. The intervention we focused on was a subcutaneous injection of inclisiran (284 mg) in the seven trials. Of the total population, 2411 (35%) had diabetes mellitus (DM) and 5335 (78.1%) had hypertension (HTN). The seven trials documented a significant reduction in the mean LDL-C level following the inclisiran application. Early inclisiran administration recorded better results. Inclisiran was found to be efficient, safe, and tolerable among atherosclerotic cardiovascular disease (ASCVD) patients. An inclisiran regimen of 284 mg proved to be efficacious and safe for reducing ASCVD. Most of the affected participants were males and hypertensive. Our findings highlight the need for additional clinical trials to examine inclisiran's safety and effectiveness with regard to cardiovascular outcomes. Extended surveillance studies may yield deeper insights into the efficacy, durability, and tolerability of inclisiran.

摘要

本系统评价综合了当前证据,以评估inclisiran降低低密度脂蛋白胆固醇(LDL-C)的安全性和有效性。我们在四个主要数据库——PubMed、Web of Science、SCOPUS和ScienceDirect——中进行了全面检索,以查找过去五年(2020 - 2024年)发表在文献中的相关研究。我们纳入了七项研究,共有6831名参与者,其中4661名(68.2%)为男性。随访时间从60天到1350天不等。我们关注的干预措施是在七项试验中皮下注射inclisiran(284毫克)。在总人群中,2411名(35%)患有糖尿病(DM),5335名(78.1%)患有高血压(HTN)。七项试验记录了应用inclisiran后平均LDL-C水平的显著降低。早期给予inclisiran取得了更好的结果。在动脉粥样硬化性心血管疾病(ASCVD)患者中,inclisiran被发现是有效、安全且可耐受的。284毫克的inclisiran方案被证明对降低ASCVD有效且安全。大多数受影响的参与者为男性且患有高血压。我们的研究结果强调需要进行更多临床试验,以检验inclisiran在心血管结局方面的安全性和有效性。扩展的监测研究可能会对inclisiran的疗效、持久性和耐受性产生更深入的见解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5544/11519579/9118aba65fde/cureus-0016-00000070411-i01.jpg

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