Vericiguat in heart failure with reduced ejection fraction: hope or solid reality?
Cyclic guanosine monophosphate
HFrEF
Heart failure
Stimulator of soluble guanylate cyclase
Vericiguat
sGC
Journal
Heart failure reviews
ISSN: 1573-7322
Titre abrégé: Heart Fail Rev
Pays: United States
ID NLM: 9612481
Informations de publication
Date de publication:
23 Jul 2024
23 Jul 2024
Historique:
accepted:
16
07
2024
medline:
24
7
2024
pubmed:
24
7
2024
entrez:
23
7
2024
Statut:
aheadofprint
Résumé
In recent years, thanks to the advent of new classes of drugs (ARNI and SGLT2-i), the prognosis of patients suffering from heart failure with reduced ejection fraction (HFrEF) has gradually improved. Nonetheless, there is a residual risk that is not targeted by these therapies. Currently, it is recognized that vericiguat, an oral stimulator of soluble guanylate cyclase (sGC), can restore the NO-sGC-cGMP pathway, through stimulation and activation of sGC, aiming to increase cGMP levels with a reduction in heart failure-related oxidative stress and endothelial dysfunction. Even though the Victoria trial demonstrated that HFrEF patients in treatment with vericiguat showed a 10% reduction in the composite of cardiovascular mortality and rehospitalization for heart failure, statistically significantly reducing heart failure hospitalization, the international guidelines limit its use as a second-line drug for patients with worsening symptomatology despite optimized medical therapy. Furthermore, vericiguat has proved to be a valid therapeutic ally especially in those patients with comorbidities such that they cannot receive the classic four-pillar therapy of HF (in particular renal failure). In this review, the authors report on randomized clinical trials, substudies, and meta-analysis about vericiguat in HFrEF, emphasizing the strengths that would suggest the possible role of vericiguat as the fifth pillar of the HFrEF treatment, acknowledging that there are still gaps in the evidence that need to be clarified.
Identifiants
pubmed: 39044114
doi: 10.1007/s10741-024-10425-7
pii: 10.1007/s10741-024-10425-7
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
Références
McDonagh TA, Metra M, Adamo M et al (2021) ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure [published correction appears in Eur Heart J. 2021 Oct 14]. Eur Heart J 42(36):3599–3726. https://doi.org/10.1093/eurheartj/ehab368
doi: 10.1093/eurheartj/ehab368
pubmed: 34447992
Snipelisky D, Chaudhry SP, Stewart GC (2019) The many faces of heart failure. Card Electrophysiol Clin 11(1):11–20. https://doi.org/10.1016/j.ccep.2018.11.001 . Epub 2018 Dec 24 PMID: 30717842
doi: 10.1016/j.ccep.2018.11.001
pubmed: 30717842
La Franca E, Manno G, Ajello L et al (2021) Physiopathology and diagnosis of congestive heart failure: consolidated certainties and new perspectives. Curr Probl Cardiol. 46(3):100691. https://doi.org/10.1016/j.cpcardiol.2020.100691 . Epub 2020 Aug 29 PMID: 33012532
doi: 10.1016/j.cpcardiol.2020.100691
pubmed: 33012532
Visco V, Radano I, Campanile A et al (2022) Predictors of sacubitril/valsartan high dose tolerability in a real world population with HFrEF. ESC Heart Fail. 9:2909–2917
doi: 10.1002/ehf2.13982
pubmed: 35702942
pmcid: 9715790
Dattilo G, Laterra G, Licordari R et al (2023) The long-term benefit of sacubitril/valsartan in patients with HFrEF: a 5-year follow-up study in a real world population. J Clin Med 28(12):6247
doi: 10.3390/jcm12196247
Dini FL, Carluccio E, Bitto R, Working group on heart failure of the Italian Society of Cardiology et al (2022) Echocardiographically defined haemodynamic categorization predicts prognosis in ambulatory heart failure patients treated with sacubitril/valsartan. ESC Heart Fail 9:1107–1117
pubmed: 35122477
pmcid: 8934975
Carluccio E, Dini FL, Bitto R, Working group on heart failure of the Italian Society of Cardiology et al (2022) Benefit from sacubitril/valsartan is associated with hemodynamic improvement in heart failure with reduced ejection fraction: an echocardiographic study. Int J Cardiol 350:62–68
doi: 10.1016/j.ijcard.2022.01.004
pubmed: 34998946
Casale M, Mezzetti M, Gigliotti De Fazio M et al (2022) Novel active fixation lead guided by electrical delay can improve response to cardiac resynchronization therapy in heart failure. ESC. Heart Fail. 9:146–154
Corrado E, Dattilo G, Coppola G et al (2022) Low- vs high-dose ARNI effects on clinical status, exercise performance and cardiac function in real-life HFrEF patients. Eur J Clin Pharmacol 78(1):19–25
doi: 10.1007/s00228-021-03210-0
pubmed: 34554274
Dattilo G, Bitto R, Correale M et al (2022) Trend of perceived quality of life and functional capacity in outpatients with chronic heart failure and in treatment with sacubitril/valsartan: a real-life experience. Minerva Cardiol Angiol. 70(5):555–562
doi: 10.23736/S2724-5683.20.05494-8
pubmed: 33823573
Casale M, Correale M, Laterra G et al (2021) Effects of sacubitril/valsartan in patients with high arrhythmic risk and an ICD: A Longitudinal Study. Clin Drug Investig 41(2):169–176
doi: 10.1007/s40261-020-00995-3
pubmed: 33484468
de Gregorio C, Laterra G, Vaccaro V et al (2020) Time-based clinical and functional achievements in real-life HF patients on ARNI treatment. Eur J Intern Med 76:115–117
doi: 10.1016/j.ejim.2020.02.007
pubmed: 32089420
Emdin M, Aimo A, Castiglione V, Vergaro G, Georgiopoulos G, Saccaro LF, Lombardi CM, Passino C, Cerbai E, Metra M, Senni M (2020) Targeting cyclic guanosine monophosphate to treat heart failure: JACC review topic of the week. J Am Coll Cardiol 76(15):1795–1807
doi: 10.1016/j.jacc.2020.08.031
pubmed: 33032741
Infante T, Costa D, Napoli C (2021) Novel insights regarding nitric oxide and cardiovascular diseases. Angiology 72(5):411–425. https://doi.org/10.1177/0003319720979243
doi: 10.1177/0003319720979243
pubmed: 33478246
Aimo A, Castiglione V, Vergaro G et al (2022) The place of vericiguat in the landscape of treatment for heart failure with reduced ejection fraction. Heart Fail Rev 27(4):1165–1171. https://doi.org/10.1007/s10741-021-10146-1
doi: 10.1007/s10741-021-10146-1
pubmed: 34291399
McMurray JJV, Solomon SD, Inzucchi SE et al (2019) Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med 381(21):1995–2008. https://doi.org/10.1056/NEJMoa1911303
doi: 10.1056/NEJMoa1911303
pubmed: 31535829
Packer M, Anker SD, Butler J et al (2020) Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med 383(15):1413–1424. https://doi.org/10.1056/NEJMoa2022190
doi: 10.1056/NEJMoa2022190
pubmed: 32865377
Trujillo ME, Ayalasomayajula S et al (2023) Vericiguat, a novel sGC stimulator: mechanism of action, clinical, and translational science. Clin Transl Sci. 16(12):2458–2466. https://doi.org/10.1111/cts.13677
doi: 10.1111/cts.13677
pubmed: 37997225
pmcid: 10719466
Breitenstein S, Roessig L et al (2016) Novel sGC stimulators and sGC activators for the treatment of heart failure. Part of the Handbook of Experimental Pharmacology book series (HEP, volume 243). https://doi.org/10.1007/164_2016_100
Boettcher M, Gerisch M, Lobmeyer M et al (2020) Metabolism and pharmacokinetic drug-drug interaction profile of vericiguat, a soluble guanylate cyclase stimulator: results from preclinical and phase I healthy volunteer studies. Clin Pharmacokinet 59(11):1407–1418. https://doi.org/10.1007/s40262-020-00895-x
doi: 10.1007/s40262-020-00895-x
pubmed: 32458378
pmcid: 7658073
González-Juanatey JR, Anguita-Sánchez M, Bayes-Genís A et al (2022) Vericiguat in heart failure: from scientific evidence to clinical practice. Rev Clin Esp (Barc). 222(6):359–369. https://doi.org/10.1016/j.rceng.2021.12.006
doi: 10.1016/j.rceng.2021.12.006
pubmed: 35473692
Correale M, Tricarico L, Croella F, Alfieri S, Fioretti F, Brunetti ND, Inciardi RM, Nodari S (2023) Novelties in the pharmacological approaches for chronic heart failure: new drugs and cardiovascular targets. Front Cardiovasc Med. 2(10):1157472
doi: 10.3389/fcvm.2023.1157472
Pieske B, Butler J, Filippatos G et al (2014) SOCRATES investigators and coordinators. rationale anddesign of the Soluble Guanylate Cyclase Stimulator in Heartfailure Studies (SOCRATES). Eur J Heart Fail. 16:1026–1038
doi: 10.1002/ejhf.135
pubmed: 25056511
Gheorghiade M, Greene SJ, Butler J et al (2015) SOCRATES-REDUCED investigators and coordinators 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. JAMA 314:2251–2262
doi: 10.1001/jama.2015.15734
pubmed: 26547357
Armstrong PW, Pieske B, Anstrom KJ, VICTORIA study group et al (2020) Vericiguat in patients with heart failure and reduced ejection fraction. N Engl J Med. 382:1883–1893
doi: 10.1056/NEJMoa1915928
pubmed: 32222134
Voors AA, Mulder H, Reyes E, VICTORIA study group et al (2021) 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. Eur JHeart Fail 23:1313–1321. https://doi.org/10.1002/ejhf.2221
doi: 10.1002/ejhf.2221
McMurray JJ, Packer M, Desai AS et al (2013) Dual angiotensin receptor and neprilysin inhibition as an alternative to angiotensin-converting enzyme inhibition in patients with chronic systolic heart failure: rationale for and design of the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF). Eur J Heart Fail 15(9):1062–1073. https://doi.org/10.1093/eurjhf/hft052
doi: 10.1093/eurjhf/hft052
pubmed: 23563576
pmcid: 3746839
Aimo A, Pateras K, Stamatelopoulos K et al (2021) Relative efficacy of sacubitril-valsartan, vericiguat, and SGLT2 inhibitors in heart failure with reduced ejection fraction: a systematic review and network meta-analysis. Cardiovasc Drugs Ther 35:1067–1076. https://doi.org/10.1007/s10557-020-07099-2
doi: 10.1007/s10557-020-07099-2
pubmed: 33074526
Kang DW, Kang SH, Lee K, Nam K, Kim ES, Yoon JC, Park SK (2024) Comparative efficacy of vericiguat to sacubitril/valsartan for patients with heart failure reduced ejection fraction: systematic review and network meta-analysis. Int J Cardiol 400:131786. https://doi.org/10.1016/j.ijcard.2024.131786 . Epub 2024 Jan 17 PMID: 38242507
doi: 10.1016/j.ijcard.2024.131786
pubmed: 38242507
Pagnesi M, Baldetti L, Aimo A, Inciardi RM, Tomasoni D, Vizzardi E, Vergaro G, Emdin M, Lombardi CM (2022) Prognostic benefit of new drugs for HFrEF: a systematic review and network meta-analysis. J Clin Med 11(2):348. https://doi.org/10.3390/jcm11020348
doi: 10.3390/jcm11020348
pubmed: 35054042
pmcid: 8777808
Ponikowski P, Alemayehu W et al (2021) Vericiguat in patients with atrial fibrillation and heart failure with reduced ejection fraction: insights from the VICTORIA trial. Eur J Heart Fail. 23(8):1300–1312. https://doi.org/10.1002/ejhf.2285
doi: 10.1002/ejhf.2285
pubmed: 34191395
Lam CSP, Mulder H, Lopatin Y et al (2021) Blood pressure and safety events with vericiguat in the VICTORIA trial. J Am Heart Assoc 10(22):e021094. https://doi.org/10.1161/JAHA.121.021094
doi: 10.1161/JAHA.121.021094
pubmed: 34743540
pmcid: 8751950
Ezekowitz JA, Zheng Y, Cohen-Solal A, Melenovský V, Escobedo J, Butler J, Hernandez AF, Lam CSP, O’Connor CM, Pieske B, Ponikowski P, Voors AA, de Filippi C, Westerhout CM, McMullan C, Roessig L, Armstrong PW (2021) Hemoglobin and clinical outcomes in the vericiguat global study in patients with heart failure and reduced ejection fraction (VICTORIA). Circulation 144(18):1489–1499. https://doi.org/10.1161/CIRCULATIONAHA.121.056797 . Epub 2021 Aug 25 PMID: 34432985
doi: 10.1161/CIRCULATIONAHA.121.056797
pubmed: 34432985
Mentz RJ, Stebbins A, Butler J, Chiang CE, Ezekowitz JA, Hernandez AF, Hilkert R, Lam CSP, McDonald K, O’Connor CM, Pieske B, Ponikowski P, Roessig L, Sweitzer NK, Voors AA, Anstrom KJ, Armstrong PW, VICTORIA Study Group (2024) Recurrent hospitalizations and response to vericiguat in heart failure and reduced ejection fraction. JACC Heart Fail 12(5):839–846. https://doi.org/10.1016/j.jchf.2023.12.005 . Epub 2024 Feb 14. PMID: 38363272
doi: 10.1016/j.jchf.2023.12.005
pubmed: 38363272
Butler J, Djatche LM, Lautsch D, Yang L, Patel MJ, Mentz RJ (2021) Representativeness of the VICTORIA trial population in clinical practice: analysis of the PINNACLE registry. J Card Fail 27(12):1374–1381. https://doi.org/10.1016/j.cardfail.2021.06.019
doi: 10.1016/j.cardfail.2021.06.019
pubmed: 34271161
Khan MS, Xu H, Fonarow GC et al (2023) Applicability of vericiguat to patients hospitalized for heart failure in the United States. JACC Heart Fail. 11(2):211–223. https://doi.org/10.1016/j.jchf.2022.11.007
doi: 10.1016/j.jchf.2022.11.007
pubmed: 36754528
pmcid: 11045268
McDonagh TA, Metra M, Adamo M et al (2023) Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure [published correction appears in Eur Heart J 2024 45(1):53]. Eur Heart J 44(37):3627–3639. https://doi.org/10.1093/eurheartj/ehad195
doi: 10.1093/eurheartj/ehad195
pubmed: 37622666
Greene SJ, Bauersachs J, Brugts JJ et al (2023) Management of worsening heart failure with reduced ejection fraction: JACC focus seminar 3/3. J Am Coll Cardiol 82(6):559–571. https://doi.org/10.1016/j.jacc.2023.04.057
doi: 10.1016/j.jacc.2023.04.057
pubmed: 37532426
Di Fusco SA, Alonzo A, Aimo A et al (2023) ANMCO Position paper: vericiguat use in heart failure: from evidence to place in therapy. G Ital Cardiol (Rome) 24(4):323–331. https://doi.org/10.1714/4004.39824
doi: 10.1714/4004.39824
pubmed: 36971177
Vannuccini F, Campora A, Barilli M, Palazzuoli A (2022) Vericiguat in heart failure: characteristics, scientific evidence and potential clinical applications. Biomedicines. 10(10):2471. https://doi.org/10.3390/biomedicines10102471 . PMID:36289733;PMCID:PMC9598881
doi: 10.3390/biomedicines10102471
pubmed: 36289733
pmcid: 9598881
Saldarriaga C, Atar D, Stebbins A, Lewis BS, Abidin IZ, Blaustein RO, Butler J, Ezekowitz JA, Hernandez AF, Lam CSP, O’Connor CM, Pieske B, Ponikowski P, Roessig L, Voors AA, Anstrom KJ, Armstrong PW, VICTORIA Study Group (2022) Vericiguat in patients with coronary artery disease and heart failure with reduced ejection fraction. Eur J Heart Fail 24(5):782–790
doi: 10.1002/ejhf.2468
pubmed: 35239245
Pieske B, Pieske-Kraigher E et al (2023) Effect of vericiguat on left ventricular structure and function in patients with heart failure with reduced ejection fraction: the VICTORIA echocardiographic substudy. Eur J Heart Fail 25(7):1012–1021. https://doi.org/10.1002/ejhf.2836
doi: 10.1002/ejhf.2836
pubmed: 36994634
Lam CSP, Giczewska A, Sliwa K, Edelmann F, Refsgaard J, Bocchi E, Ezekowitz JA, Hernandez AF, O’Connor CM, Roessig L, Patel MJ, Pieske B, Anstrom KJ, Armstrong PW, VICTORIA Study Group (2021) Clinical outcomes and response to vericiguat according to index heart failure event: insights from the VICTORIA trial. JAMA Cardiol. 6(6):706–712. https://doi.org/10.1001/jamacardio.2020.6455 . Erratum in: JAMA Cardiol. 2021 Jan 13;: Erratum in: JAMA Cardiol. 2021 Jun 1;6(6):728. Erratum in: JAMA Cardiol. 2021 Oct 6;:null. PMID: 33185650; PMCID: PMC7666431
doi: 10.1001/jamacardio.2020.6455
pubmed: 33185650
A pivotal phase 3 randomized, placebo-controlled clinical study to evaluate the efficacy and safety of the sGC stimulator vericiguat/MK-1242 in adults with chronic heart failure with reduced ejection fraction (VICTOR-HF). 2020-005941-18 (EudraCT Number)