Rapid health technology assessment of the efficacy， safety and cost-effectiveness of vericiguat in the treatment of heart failure

KE Yijun; WANG Wei; HUANG Can; JIN Yong; QI Lamei

doi:10.6039/j.issn.1001-0408.2024.15.04

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Rapid health technology assessment of the efficacy， safety and cost-effectiveness of vericiguat in the treatment of heart failure

更新时间：2025-09-23

- Rapid health technology assessment of the efficacy， safety and cost-effectiveness of vericiguat in the treatment of heart failure
- ZHONGGUO YAOFANG Vol. 35, Issue 15, Pages: 1818-1824(2024)
- 作者机构：
  
  1.安庆市立医院药事管理科，安徽安庆　246000
  2.安庆市立医院消化内科，安徽安庆　246000
  3.安徽医科大学校医院，合肥　230000
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.15.04
  CLC： R972+.4
- Received：28 November 2023，
  
  Revised：2024-03-29，
  
  Accepted：01 April 2024，
  
  Published：15 August 2024
- 稿件说明：
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柯义君,王威,黄灿,等.维立西呱治疗心力衰竭有效性、安全性及经济性的快速卫生技术评估 [J].中国药房,2024,35(15):1818-1824.

KE Yijun,WANG Wei,HUANG Can,et al.Rapid health technology assessment of the efficacy， safety and cost-effectiveness of vericiguat in the treatment of heart failure[J].ZHONGGUO YAOFANG,2024,35(15):1818-1824.
柯义君,王威,黄灿,等.维立西呱治疗心力衰竭有效性、安全性及经济性的快速卫生技术评估 [J].中国药房,2024,35(15):1818-1824. DOI： 10.6039/j.issn.1001-0408.2024.15.04.

KE Yijun,WANG Wei,HUANG Can,et al.Rapid health technology assessment of the efficacy， safety and cost-effectiveness of vericiguat in the treatment of heart failure[J].ZHONGGUO YAOFANG,2024,35(15):1818-1824. DOI： 10.6039/j.issn.1001-0408.2024.15.04.

摘要

目的

采用快速卫生技术评估方法，评价维立西呱治疗心力衰竭（HF）的有效性、安全性、经济性，为临床治疗方案的选择和决策提供参考依据。

方法

计算机检索中国知网、PubMed等中外数据库及相关卫生技术评估网站。相关研究人员独立筛选文献、提取资料，在文献质量评价的基础上，对纳入文献的结果进行综合分析。

结果

共纳入文献17篇，其中系统评价/Meta分析12篇，药物经济学研究5篇。有效性分析结果显示：对于

HF患者，相比于安慰剂，维立西呱（10 mg/d）可显著改善欧洲五维生存质量量表（EQ-5D）指数和降低因HF住院发生率（

＜0.05）；对于射血分数降低的心力衰竭（HFrEF）患者，相比于钠-葡萄糖共转运蛋白2抑制剂（SGLT2i），维立西呱可显著降低因HF住院发生率（

＜0.05），而相比于血管紧张素转化酶抑制剂，维立西呱可显著降低心血管死亡或因HF住院的复合终点事件的发生风险（

＜0.05）；对于HFrEF合并慢性肾脏病的患者，相比于神经激素抑制剂，维立西呱有降低心血管死亡或因HF住院的复合终点事件的发生风险的趋势。安全性分析结果显示：相比于安慰剂，维立西呱不会增加药物相关不良反应发生率（

＞0.05）。经济学分析结果显示：国内研究表明维立西呱具有较高的增量成本-效果比。

结论

维立西呱治疗HF具有较好的安全性和有效性，但在中国人群中并不具有经济优势。

Abstract

OBJECTIVE

To evaluate the efficacy， safety and cost-effectiveness of vericiguat in the treatment of heart failure （HF） by rapid health technology evaluation method， and provide reference for the selection and decision-making of clinical treatment plans.

METHODS

Chinese and foreign databases such as CNKI， PubMed and related health technology evaluation websites were searched by computer. Relevant researchers independently screened literature， extracted data， and comprehensively analyzed the results of the included literature based on literature quality evaluation.

RESULTS

A total of 17 pieces of literature were included， involving 12 systematic reviews/meta-analyses and 5 pharmacoeconomic studies. The effectiveness analysis showed： for HF patients， compared with placebo， vericiguat （10 mg/d） significantly improved the EuroQol five dimensions questionnaire （EQ-5D） index and decreased the rate of hospitalization due to HF （

＜0.05）. For heart failure with reduced ejection fraction （HFrEF） patients， vericiguat reduced the incidence of hospitalization due to HF compared with sodium-glucose cotransporter 2 inhibitor （SGLT2i）（

＜0.05）； compared with angiotensin-converting enzyme inhibitor， vericiguat significantly reduced the occurrence risk of composite endpoints of cardiovascular death or hospitalization due to HF（

＜0.05）. For HFrEF pati

ents with chronic kidney disease， vericiguat had a tendency to reduce the occurrence risk of composite endpoints of cardiovascular death or hospitalization due to HF compared with neurohormone inhibitors. Safety analysis showed： vericiguat did not increase drug-related adverse reactions compared to placebo （

＞0.05）. Economic analysis showed： domestic studies indicated that vericiguat had a higher incremental cost-effectiveness ratio.

CONCLUSIONS

Vericiguat has good safety and efficacy in the treatment of HF but does not possess an economic advantage in the Chinese population.

关键词

Keywords

references

GROENEWEGEN A ， RUTTEN F H ， MOSTERD A ， et al . Epidemiology of heart failure [J ] . Eur J Heart Fail ， 2020 ， 22 （ 8 ）： 1342 - 1356 .

TROMP J ， FERREIRA J P ， JANWANISHSTAPORN S ， et al . Heart failure around the world [J ] . Eur J Heart Fail ， 2019 ， 21 （ 10 ）： 1187 - 1196 .

SAVARESE G ， BECHER P M ， LUND L H ， et al . Global burden of heart failure：a comprehensive and updated review of epidemiology [J ] . Cardiovasc Res ， 2023 ， 118 （ 17 ）： 3272 - 3287 .

SANDNER P ， STASCH J P . Anti-fibrotic effects of soluble guanylate cyclase stimulators and activators：a review of the preclinical evidence [J ] . Respir Med ， 2017 ， 122 ： S1 - S9 .

RAPÔSO C ， LUNA R L ， NUNES A K ， et al . Role of iNOS-NO-cGMP signaling in modulation of inflammatory and myelination processes [J ] . Brain Res Bull ， 2014 ， 104 ： 60 - 73 .

ARMSTRONG P W ， PIESKE B ， ANSTROM K J ， et al . Vericiguat in patients with heart failure and reduced ejection fraction [J ] . N Engl J Med ， 2020 ， 382 （ 20 ）： 1883 - 1893 .

GHEORGHIADE M ， GREENE S J ， BUTLER J ， et al . Effect of vericiguat，a soluble guanylate cyclase stimulator，on natriuretic peptide levels in patients with worsening chronic heart failure and reduced ejection fraction：the SOCRATES-REDUCED randomized trial [J ] . JAMA ， 2015 ， 314 （ 21 ）： 2251 - 62 .

PIESKE B ， MAGGIONI A P ， LAM C S P ， et al . Vericiguat in patients with worsening chronic heart failure and preserved ejection fraction：results of the soluble guanylate cyclase stimulator in heart failure patients with preserved EF （SOCRATES-PRESERVED） study [J ] . Eur Heart J ， 2017 ， 38 （ 15 ）： 1119 - 1127 .

ARMSTRONG P W ， LAM C S P ， ANSTROM K J ， et al . Effect of vericiguat vs.placebo on quality of life in patients with heart failure and preserved ejection fraction：the VITALITY-HFpEF randomized clinical trial [J ] . JAMA ， 2020 ， 324 （ 15 ）： 1512 - 1521 .

TROMP J ， OUWERKERK W ， VAN VELDHUISEN D J ， et al . A systematic review and network meta-analysis of pharmacological treatment of heart failure with reduced ejection fraction [J ] . JACC Heart Fail ， 2022 ， 10 （ 2 ）： 73 - 84 .

PAGNESI M ， BALDETTI L ， AIMO A ， et al . Prognostic benefit of new drugs for HFrEF：a systematic review and network meta-analysis [J ] . J Clin Med ， 2022 ， 11 （ 2 ）： 348 .

INAHTA . INAHTA HTA checklist English [EB/OL ] . [ 2023-10-05 ] . http：//www.inata.org/wpcontent/uploads/2014/04/INAHTA_HTA_Checklist_English.pdf http://www.inata.org/wpcontent/uploads/2014/04/INAHTA_HTA_Checklist_English.pdf .

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 .

HUTTON B ， CATALÁ-LÓPEZ F ， MOHER D . The PRISMA statement extension for systematic reviews incorporating network meta-analysis：PRISMA-NMA [J ] . Med Clin ， 2016 ， 147 （ 6 ）： 262 - 266 .

HUSEREAU D ， DRUMMOND M ， AUGUSTOVSKI F ， et al . Consolidated Health Economic Evaluation Repor- ting Standards 2022 （CHEERS 2022） statement：updated reporting guidance for health economic evaluations [J ] . J Manag Care Spec Pharm ， 2022 ， 28 （ 2 ）： 146 - 155 .

ZHENG X Y ， ZHENG W J ， XIONG B ， et al . The efficacy and safety of soluble guanylate cyclase stimulators in patients with heart failure [J ] . Medicine ， 2018 ， 97 （ 41 ）： e12709 .

LIN Y W ， WU M S ， LIAO B H ， et al . Comparison of pharmacological treatment effects on long-time outcomes in heart failure with preserved ejection fraction：a network meta-analysis of randomized controlled trials [J ] . Front Pharmacol ， 2021 ， 12 ： 707777 .

LI Q ， LI Z Q ， LI T T ， et al . Efficacy and safety of soluble guanylate cyclase stimulators in patients with heart fai- lure：a systematic review and meta-analysis [J ] . Die Pharm ， 2021 ， 76 （ 10 ）： 488 - 493 .

MA J H ， GUO S ， JIANG H ， et al . Efficacy and safety of vericiguat in heart failure：a meta-analysis [J ] . J Int Med Res ， 2023 ， 51 （ 3 ）： 3000605231159333 .

AMERI P ， DE MARZO V ， ZOCCAI G B ， et al . Efficacy of new medical therapies in patients with heart failure，reduced ejection fraction，and chronic kidney disease already receiving neurohormonal inhibitors：a network meta-analysis [J ] . Eur Heart J Cardiovasc Pharmacother ， 2022 ， 8 （ 8 ）： 768 - 776 .

DE MARZO V ， SAVARESE G ， TRICARICO L ， et al . Network meta-analysis of medical therapy efficacy in more than 90 000 patients with heart failure and reduced ejection fraction [J ] . J Intern Med ， 2022 ， 292 （ 2 ）： 333 - 349 .

AIMO A ， PATERAS K ， STAMATELOPOULOS K ， et al . Relative efficacy of sacubitril-valsartan，vericiguat，and SGLT2 inhibitors in heart failure with reduced ejection fraction：a systematic review and network meta-analysis [J ] . Cardiovasc Drugs Ther ， 2021 ， 35 （ 5 ）： 1067 - 1076 .

ULLAH W ， MUKHTAR M ， AL-MUKHTAR A ， et al . Safety and efficacy of soluble guanylate cyclase stimulators in patients with heart failure：a systematic review and meta-analysis [J ] . World J Cardiol ， 2020 ， 12 （ 10 ）： 501 - 512 .

MA G F ， PAN Y F ， QU C Y ， et al . The efficacy of vericiguat for heart failure：a meta-analysis of randomized controlled trials [J ] . Medicine ， 2023 ， 102 （ 21 ）： e33807 .

贾晓艳，安晋阳，彭可玲，等 . 可溶性鸟苷酸环化酶激动剂治疗心力衰竭疗效和安全性的网状Meta分析 [J ] . 中国新药与临床杂志， 2023 ， 42 （ 1 ）： 48 - 57 .

JIA X Y ， AN J Y ， PENG K L ， et al . Efficacy and safety of soluble guanylate cyclase stimulators in treatment of heart failure：a network meta-analysis [J ] . Chin J N Drugs Clin Remedies ， 2023 ， 42 （ 1 ）： 48 - 57 .

黎风，何梅，母立峰，等 . 维立西呱治疗射血分数降低的心力衰竭的药物经济学研究 [J ] . 中国药房， 2023 ， 34 （ 15 ）： 1869 - 1873 .

LI F ， HE M ， MU L F ， et al . Study on pharmacoeconomic evaluation of vericiguat in the treatment of heart failure with reduced ejection fraction [J ] . China Pharm ， 2023 ， 34 （ 15 ）： 1869 - 1873 .

ALSUMALI A ， LAUTSCH D ， LIU R Z ， et al . Budget impact analysis of vericiguat for the treatment of chronic heart failure with reduced ejection fraction following a worsening event [J ] . Adv Ther ， 2021 ， 38 （ 5 ）： 2631 - 2643 .

ALSUMALI A ， DJATCHE L M ， BRIGGS A ， et al . Cost effectiveness of vericiguat for the treatment of chronic heart failure with reduced ejection fraction following a worsening heart failure event from a US medicare perspective [J ] . Pharmacoeconomics ， 2021 ， 39 （ 11 ）： 1343 - 1354 .

CHEW D S ， LI Y ， BIGELOW R ， et al . Cost-effectiveness of vericiguat in patients with heart failure with reduced ejection fraction：the VICTORIA randomized clinical trial [J ] . Circulation ， 2023 ， 148 （ 14 ）： 1087 - 1098 .

YU X ， HAO Y ， ZHU Z ， et al . Vericiguat for the treatment of heart failure with reduced ejection fraction following a worsening heart failure event：a cost-effectiveness analysis from the perspective of Chinese healthcare providers [J ] . Clin Drug Investig ， 2023 ， 43 （ 4 ）： 241 - 250 .

BUTLER J ， DJATCHE L M ， SAWHNEY B ， et al . Clinical and economic burden of chronic heart failure and reduced ejection fraction following a worsening heart failure event [J ] . Adv Ther ， 2020 ， 37 （ 9 ）： 4015 - 4032 .

BUTLER J ， YANG M ， MANZI M A ， et al . Clinical course of patients with worsening heart failure with reduced ejection fraction [J ] . J Am Coll Cardiol ， 2019 ， 73 （ 8 ）： 935 - 944 .

LAM C S P ， GICZEWSKA A ， SLIWA K ， et al . Clinical outcomes and response to vericiguat according to index heart failure event：insights from the VICTORIA trial [J ] . JAMA Cardiol ， 2021 ， 6 （ 6 ）： 706 - 712 .

EZEKOWITZ J A ， O’CONNOR C M ， TROUGHTON R W ， et al . N-terminal pro-B-type natriuretic peptide and clinical outcomes：vericiguat heart failure with reduced ejection fraction study [J ] . JACC Heart Fail ， 2020 ， 8 （ 11 ）： 931 - 939 .

ZILE M R ， CLAGGETT B L ， PRESCOTT M F ， et al . Prognostic implications of changes in N-terminal pro-B-type natriuretic peptide in patients with heart failure [J ] . J Am Coll Cardiol ， 2016 ， 68 （ 22 ）： 2425 - 2436 .

VOORS A A ， MULDER H ， REYES E ， et al . Renal function and the effects of vericiguat in patients with worsening heart failure with reduced ejection fraction：insights from the VICTORIA （vericiguat global study in subjects with HFrEF） trial [J ] . Eur J Heart Fail ， 2021 ， 23 （ 8 ）： 1313 - 1321 .

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