Rapid health technology assessment of inclisiran in the treatment of atherosclerotic cardiovascular disease with hypercholesterolemia

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Rapid health technology assessment of inclisiran in the treatment of atherosclerotic cardiovascular disease with hypercholesterolemia

更新时间：2025-10-11

- Rapid health technology assessment of inclisiran in the treatment of atherosclerotic cardiovascular disease with hypercholesterolemia
- ZHONGGUO YAOFANG Vol. 36, Issue 19, Pages: 2460-2465(2025)
- 作者机构：
  
  1.徐州医科大学附属医院药学部，江苏徐州　221004
  2.徐州医科大学附属医院麻醉科，江苏徐州　221004
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2025.19.18
  CLC： R973+.1;R969.3;R956
- Received：14 May 2025，
  
  Revised：2025-09-01，
  
  Accepted：01 September 2025，
  
  Published：15 October 2025
- 稿件说明：
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高杏,刘天雅,张倩,等.英克司兰治疗动脉粥样硬化性心血管疾病伴高胆固醇血症的快速卫生技术评估[J].中国药房,2025,36(19):2460-2465.

GAO Xing,LIU Tianya,ZHANG Qian,et al.Rapid health technology assessment of inclisiran in the treatment of atherosclerotic cardiovascular disease with hypercholesterolemia[J].ZHONGGUO YAOFANG,2025,36(19):2460-2465.
高杏,刘天雅,张倩,等.英克司兰治疗动脉粥样硬化性心血管疾病伴高胆固醇血症的快速卫生技术评估[J].中国药房,2025,36(19):2460-2465. DOI： 10.6039/j.issn.1001-0408.2025.19.18.

GAO Xing,LIU Tianya,ZHANG Qian,et al.Rapid health technology assessment of inclisiran in the treatment of atherosclerotic cardiovascular disease with hypercholesterolemia[J].ZHONGGUO YAOFANG,2025,36(19):2460-2465. DOI： 10.6039/j.issn.1001-0408.2025.19.18.

摘要

目的

2

评估英克司兰在动脉粥样硬化性心血管疾病伴高胆固醇血症治疗中的有效性、安全性和经济性。

方法

2

采用快速卫生技术评估（HTA）方法。通过检索PubMed、Embase、the Cochrane Library、中国知网、万方等中英文数据库和HTA官方网站，收集英克司兰相关HTA报告、系统评价（SR）/Meta分析和药物经济学研究，检索时限为建库起至2025年4月。通过文献筛选、数据提取及文献质量评价，对研究结果进行描述性分析和汇总。

结果

2

最终纳入22篇文献，包括HTA报告1篇，SR/Meta分析15篇，药物经济学研究6篇。有效性方面，与对照组相比，英克司兰能够显著降低低密度脂蛋白胆固醇、前蛋白转化酶枯草溶菌素9、总胆固醇、甘油三酯、载脂蛋白B和脂蛋白（a）水平，升高高密度脂蛋白胆固醇水平，降低心血管不良事件风险。安全性方面，英克司兰组总不良事件、严重不良事件和非严重不良事件的发生风险与对照组差异无统计学意义，但是注射部位反应发生率升高，且多为轻度。经济性方面，国内外研究结论存在差异，更多研究表明英克司兰不具备经济性优势，需适当降价才能符合成本-效果标准。

结论

2

英克司兰治疗动脉粥样硬化性心血管疾病伴高胆固醇血症疗效显著、安全性良好，但其经济性有待进一步提高。

Abstract

OBJECTIVE

2

To evaluate the efficacy， safety and economy of inclisiran in the treatment of atherosclerotic cardiovascular disease with hypercholesterolemia.

METHODS

2

A rapid health technology assessment （HTA） approach was employed. HTA reports， systematic reviews（SR）/meta-analyses， and pharmacoeconomic studies related to inclisiran were systematically identified through comprehensive searches of Chinese and English databases， including PubMed， Embase， the Cochrane Library， CNKI and Wanfang database， supplemented by HTA institutional repositories. The search timeframe spanned from database inception to April 2025. The results of the studies were descriptively analysed and summarized through literature screening， data extraction and literature quality assessment.

RESULTS

2

The final analysis included 22 studies， comprising one HTA report， 15 SR/meta-analyses， and 6 pharmacoeconomic evaluations. Regarding therapeutic efficacy， compared with control group， inclisiran could significantly reduce the levels of low-density lipoprotein cholesterol， proprotein convertase subtilisin/kexin type 9， total cholesterol， triacylglycerol， apolipoprotein B， and lipoprotein（a）， increase the level of high-density lipoprotein cholesterol， and reduce the risk of adverse cardiovascular events. In terms of safety， the inclisiran group showed no significant difference compared with the control group in the risk of total adverse events， serious adverse events， or non-serious adverse events； however， an increased incidence of injection site reactions was observed， most of which were mild. In terms of cost-effectiveness， there were discrepancies in research conclusions both domestically and internationally. More studies indicated that inclisiran did not demonstrate cost-effectiveness advantage and would require an appropriate price reduction to meet cost-effectiveness criteria.

CONCLUSIONS

2

Inclisiran demonstrates favorable efficacy and acceptable safety in treating atherosclerotic cardiovascular disease with hypercholesterolemia， though its economic profile requires improvement.

关键词

Keywords

references

国家心血管病中心，中国心血管健康与疾病报告编写组，胡盛寿 . 中国心血管健康与疾病报告2023概要 [J ] . 中国循环杂志， 2024 ， 39 （ 7 ）： 625 - 660 .

中国血脂管理指南修订联合专家委员会 . 中国血脂管理指南：2023 年[J ] . 中国循环杂志， 2023 ， 38 （ 3 ）： 237 - 271 .

BAO X H ， LIANG Y J ， CHANG H M ， et al . Targeting proprotein convertase subtilisin/kexin type 9 （PCSK9）：from bench to bedside [J ] . Signal Transduct Target Ther ， 2024 ， 9 （ 1 ）： 13 .

赵瑾，陈鹏飞，包楠迪 . 前蛋白转化酶枯草溶菌素9抑制剂的临床研究及应用进展 [J ] . 中华老年多器官疾病杂志， 2024 ， 23 （ 4 ）： 311 - 315 .

BANERJEE Y ， PANTEA STOIAN A ， CICERO A F G ， et al . Inclisiran：a small interfering RNA strategy targeting PCSK9 to treat hypercholesterolemia [J ] . Expert Opin Drug Saf ， 2022 ， 21 （ 1 ）： 9 - 20 .

RAY K K ， RAAL F J ， KALLEND D G ， et al . Inclisiran and cardiovascular events：a patient-level analysis of phase Ⅲ trials [J ] . Eur Heart J ， 2023 ， 44 （ 2 ）： 129 - 138 .

李苗苗，吴雪，徐思敏，等 . 快速卫生技术评估的概况性综述 [J ] . 中国中药杂志， 2022 ， 47 （ 12 ）： 3125 - 3135 .

HAILEY D . Toward transparency in health technology assessment：a checklist for HTA reports [J ] . Int J Technol Assess Health Care ， 2003 ， 19 （ 1 ）： 1 - 7 .

SHEA B J ， REEVES B C ， WELLS G ， et al . AMSTAR 2：a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions，or both [J ] . BMJ ， 2017 ， 358 ： j4008 .

HUSEREAU D ， DRUMMOND M ， AUGUSTOVSKI F ， et al . Consolidated health economic evaluation reporting Standards 2022 （CHEERS 2022） statement：updated reporting guidance for health economic evaluations [J ] . Value Health ， 2022 ， 25 （ 1 ）： 3 - 9 .

National Institute for Health and Care Excellence . Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia [EB/OL ] . （ 2021-10-06 ） [ 2025-05-05 ] . https：//www.nice.org.uk/guidance/ta733 https://www.nice.org.uk/guidance/ta733 .

WANG Y ， WANG J S ， WANG S M . Comparative effectiveness of inclisiran 100 300，and 500 mg in a population with hyperlipidemia：a network meta-analysis of rando- mized controlled trials [J ] . Am J Cardiovasc Drugs ， 2018 ， 18 （ 4 ）： 271 - 282 .

ASBEUTAH A A A ， ASBEUTAH S A ， ABU-ASSI M A . A meta-analysis of cardiovascular outcomes in patients with hypercholesterolemia treated with inclisiran [J ] . Am J Cardiol ， 2020 ， 128 ： 218 - 219 .

KHAN S A ， NAZ A ， QAMAR MASOOD M ， et al . Meta-analysis of inclisiran for the treatment of hypercholesterole- mia [J ] . Am J Cardiol ， 2020 ， 134 ： 69 - 73 .

CICERO A F G ， FOGACCI F ， ZAMBON A ， et al . Efficacy and safety of inclisiran：a newly approved FDA drug：a systematic review and pooled analysis of available clinical studies [J ] . Am Heart J Plus Cardiol Res Pract ， 2022 ， 13 ： 100127 .

DUTTA S ， SHAH R ， SINGHAL S ， et al . A systematic review and meta-analysis of tolerability，cardiac safety and efficacy of inclisiran for the therapy of hyperlipidemic patients [J ] . Expert Opin Drug Saf ， 2024 ， 23 （ 2 ）： 187 - 198 .

俞赟丰，周曼丽，罗晓欣，等 . Inclisiran治疗高胆固醇血症的荟萃分析和试验序贯分析 [J ] . 中国循证心血管医学杂志， 2023 ， 15 （ 9 ）： 1030 - 1035，1046 .

LI Y H ， XUE K F ， HU R ， et al . A meta-analysis of the regulation of low-density lipoprotein cholesterol and proprotein convertase subtilisin-kexin type 9 with inclisiran [J ] . Am J Cardiovasc Drugs ， 2025 ， 25 （ 2 ）： 191 - 201 .

ZHANG S X ， SUN L ， XU X Y ， et al . Efficacy and safety of inclisiran versus PCSK9 inhibitor versus statin plus ezetimibe therapy in hyperlipidemia：a systematic review and network meta-analysis [J ] . BMC Cardiovasc Disord ， 2024 ， 24 （ 1 ）： 629 .

CHEN Y F ， LI S ， WANG M J ， et al . Inclisiran treatment for cardiovascular disease risk reduction：a systematic review and meta-analysis [J ] . J Coll Physicians Surg Pak ， 2024 ， 34 （ 9 ）： 1090 - 1095 .

CHENG Z L ， GAO M L ， LIU Y ， et al . Safety and efficacy of inclisiran in treating hypercholesterolemia：a systematic review and meta-analysis [J ] . Nutr Metab Cardiovasc Dis ， 2025 ， 35 （ 5 ）： 103779 .

JAWWAD M ， RIAZ M ， MEHTAB M ， et al . Serious adverse events of inclisiran in patients with hypercholesterole- mia，a meta-analysis of ORION trials [J ] . Crit Pathw Cardiol ， 2024 ， 23 （ 1 ）： 1 - 11 .

MIRGHANI H ， ALBALAWI B H ， ALSHEHRI M S ， et al . 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 [J ] . Cureus ， 2024 ， 16 （ 9 ）： e70411 .

KHALIL I ， RAHMAN M T ， HOSSAIN I . The impact of inclisiran on lipid profiles in adults with hyperlipidemia：a meta-analysis and meta-regression of randomized controlled trials [J ] . Am J Cardiol ， 2025 ， 250 ： 20 - 29 .

MALIHA M ， SATISH V ， KUMAR S S ， et al . The safety profile of inclisiran in patients with dyslipidemia：a systematic review and meta-analysis [J ] . Healthcare （Basel）， 2025 ， 13 （ 2 ）： 141 .

BASIT J ， AHMED M ， SINGH P ， et al . Safety and efficacy of inclisiran in hyperlipidemia：an updated meta-analysis of randomised controlled trials [J ] . Endocrinol Diabetes Metab ， 2025 ， 8 （ 2 ）： e70039 .

KAM N ， PERERA K ， ZOMER E ， et al . Inclisiran as adjunct lipid-lowering therapy for patients with cardiovascular disease：a cost-effectiveness analysis [J ] . Pharmacoeconomics ， 2020 ， 38 （ 9 ）： 1007 - 1020 .

DESAI N R ， CAMPBELL C ， ELECTRICWALA B ， et al . Cost effectiveness of inclisiran in atherosclerotic cardiovascular patients with elevated low-density lipoprotein cholesterol despite statin use：a threshold analysis [J ] . Am J Cardiovasc Drugs ， 2022 ， 22 （ 5 ）： 545 - 556 .

ZHOU W J ， LIANG Z R ， LOU X H ， et al . The combination use of inclisiran and statins versus statins alone in the treatment of dyslipidemia in China’s mainland：a cost-effectiveness analysis [J ] . Front Pharmacol ， 2024 ， 15 ： 1283922 .

冯冰，高宁，高胜男，等 . 英克司兰注射液治疗动脉粥样硬化性心脏病成本效果分析 [J ] . 医药导报， 2025 ， 44 （ 3 ）： 466 - 472 .

LIM Y L ， TAN R S ， POH K K ， et al . Cost-effectiveness analysis of inclisiran for the treatment of primary hypercholesterolemia or mixed dyslipidemia in Singapore [J ] . Value Health Reg Issues ， 2025 ， 47 ： 101067 .

WANG P P ， LIANG L ， LI Y M . Cost-effectiveness analysis of evolocumab or inclisiran in combination with statins versus statin monotherapy among patients with ASCVD in China [J ] . Appl Health Econ Health Policy ， 2025 ， 23 （ 5 ）： 855 - 867 .

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