Experience with the use of valsartan/sacubitril in patients with chronic heart failure in combination with type 2 diabetes mellitus and paroxysmal atrial fibrillation
- Authors: Ignatenko A.G.1, Bagriy A.E.1, Prikolota A.V.1, Prikolota O.A.1, Mikhailichenko E.S.1, Golodnikov I.A.1, Bagriy O.N.2
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Affiliations:
- M. Gorky Donetsk State Medical University
- Donetsk Regional Clinical Territorial Medical Association
- Issue: Vol 30, No 12 (2023)
- Pages: 91-97
- Section: Original articles
- URL: https://journals.eco-vector.com/2073-4034/article/view/626053
- DOI: https://doi.org/10.18565/pharmateca.2023.12.91-97
- ID: 626053
Cite item
Abstract
Background. About 33.5 million patients suffer from atrial fibrillation (AF); which causes complications and increases mortality and disability. Compared to therapy with angiotensin-converting enzyme inhibitor and sartans; an angiotensin neprilysin receptor inhibitor (ARNI) may further improve the prognosis of cardiovascular diseases such as chronic heart failure (CHF). However; the relationship between ARNI therapy and the risk of AF recurrence is currently unknown.
Objective. Evaluation of the effect of the valsartan/sacubitril (V/S) combination on the occurrence of episodes of AF in patients with CHF and type 2 diabetes mellitus (DM2).
Methods. 53 patients with DM2 and paroxysmal AF were followed-up. All patients had CHF II–III functional classes (FC) with left ventricular (LV) ejection fraction (EF) <50%. Standard lifestyle changes were recommended; and appropriate glucose-lowering and organ-protective therapy was prescribed for all patients. The patients were divided into 2 groups: group 1 (19 patients; received V/S at a starting dose of 100 mg/day; followed by an increase to 400 mg/day) and group 2 (34 patients; received losartan at the starting dose of 50 mg/day; increasing to 150 mg/day). Before inclusion in the study and after 11.3 (5.2) months of follow-up; clinical and laboratory studies were carried out; echocardiography (Echo-CG) with tissue Doppler (TD) and Holter monitoring (HM) of the electrocardiogram (ECG) were performed over time.
Results. All patients tolerated the prescribed treatment satisfactorily. During the last 5 months before the end of follow-up period; episodes of AF occurred significantly less frequently in patients of group 1 compared to patients of group 2: 4 (21.1%) versus 17 (50%); P<0.05. In both groups; during follow-up period; a significant decrease in the left atrium volume index; functional class of CHF; glycated hemoglobin level; an increase in LVEF; and an improvement in LV diastolic function (according to Echo-CG data with TD) were noted. Moreover; these positive changes were significantly more pronounced in group 1 compared to group 2 (P<0.05).
Conclusion. The V/S combination compared with losartan in patients with CHF in combination with DM2 and paroxysmal AF was cha-racterized by satisfactory tolerability; was associated with a decrease in the frequency of arrhythmia relapses; and also caused more significant favorable changes in clinical; laboratory and instrumental parameters.
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About the authors
A. G. Ignatenko
M. Gorky Donetsk State Medical University
Email: prikav@yandex.ru
ORCID iD: 0000-0003-0562-3509
Russian Federation, Donetsk
A. E. Bagriy
M. Gorky Donetsk State Medical University
Email: prikav@yandex.ru
ORCID iD: 0000-0002-0295-3724
Russian Federation, Donetsk
Alina V. Prikolota
M. Gorky Donetsk State Medical University
Author for correspondence.
Email: prikav@yandex.ru
ORCID iD: 0000-0002-9128-2511
Cand. Sci. (Med.), Associate Professor at the Department of Therapy n.a. prof. A.I. Dyadyk, Faculty of Continuous Medical and Pharmaceutical Education
Russian Federation, DonetskO. A. Prikolota
M. Gorky Donetsk State Medical University
Email: prikav@yandex.ru
ORCID iD: 0000-0002-2127-6925
Russian Federation, Donetsk
E. S. Mikhailichenko
M. Gorky Donetsk State Medical University
Email: prikav@yandex.ru
ORCID iD: 0000-0001-8625-1406
Russian Federation, Donetsk
I. A. Golodnikov
M. Gorky Donetsk State Medical University
Email: prikav@yandex.ru
ORCID iD: 0000-0001-6866-037X
Russian Federation, Donetsk
O. N. Bagriy
Donetsk Regional Clinical Territorial Medical Association
Email: prikav@yandex.ru
ORCID iD: 0000-0003-1712-2760
Russian Federation, Donetsk
References
- Мареев В.Ю.; Фомин И.В.; Агеев Ф.Т. и др. Клинические рекомендации ОССН-РКО-РНМОТ. Сердечная недостаточность: хроническая (ХСН) и острая декомпенсированная (ОДСН). Диагностика; профилактика и лечение. Кардиология. 2018;58(Suppl. 6):8–158. [Mareev V.Yu.; Fomin I.V.; Ageev F.T. et al. Russian Heart Failure Societyn Society of Cardiology Russian Scientific Medical Society of Internal Medicine Guidelines for Heart failure: chronic (CHF) and acute decompensated (ADHF). Diagnosis; prevention and treatment. Kardiologiya. 2018;58(Suppl. 6):8–158. (In Russ.)]. doi: 10.18087/cardio.2475.
- McDonagh T.A.; Metra M.; Adamo M.; et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Failure. 2021;2(36):3599–726. doi: 10.1093/eurheartj/ehab368.
- American Diabetes Association. 10. Cardiovascular disease and risk management: Standards of Medical Care in Diabetes 2020. Diab Care. 2020;43(1):S111–34. doi: 10.2337/dc20-s010.
- Дедов И.И.; Шестакова М.В.; Майоров А.Ю. и др. Сахарный диабет 2 типа у взрослых: клинические рекомендации. Сахарный диабет. 2020;23(Suppl. 2):4–102. [Dedov I.I.; Shestakova M.V.; Mayorov A.Yu. et al. Type 2 diabetes mellitus in adults: clinical recommendations. Diabetes Mellitus. 2020;23(Suppl. 2):4–102. (In Russ.)].
- Cosentino F. Aboyans V.; Bailey C.J.; et al. 2019 ESC Guidelines on diabetes; pre-diabetes; and cardiovascular diseases developed in collaboration with the EASD: The Task Force for diabetes; pre-diabetes; and cardiovascular diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD). Eur Heart J. 2019;00:1–69.
- Jhund P.S.; Fu M.; Bayram E.; et al. Efficacy and safety of LCZ696 (sacubitril-valsartan) according to age: insights from PARADIGM-HF. Eur Heart J. 2015;36(38):2576–84. doi: 10.1093/eurheartj/ehv330. [Epub 2015 Jul 31].
- Simpson J.; Jhund P.S.; Cardoso J.S.; et al. Comparing LCZ696 with enalapril according to baseline risk using the MAGGIC and EMPHASIS-HF risk scores: an analysis of mortality and morbidity in PARADIGM-HF. J Am Coll Cardiol. 2015;66(19):2059–71. doi: 10.1016/j.jacc.2015.08.878.
- Gori M.; Volterrani M.; Piepoli M.; et al. Angiotensin receptor-neprilysin inhibitor (ARNi): Clinical studies on a new class of drugs. Int J Cardiol. 2017;226:136–40. doi: 10.1016/j.ijcard.2016.06.083.
- Solomon S.D.; Claggett B.; Packer M.; et al. Efficacy of Sacubitril/Valsartan Relative to a Prior Decompensation: The PARADIGM-HF Trial. JACC. Heart Fail. 2016;4(10):816–22. doi: 10.1016/j.jchf.2016.05.002.
- Desai A.S.; Solomon S.D.; Shah A.M.; et al. Effect of Sacubitril-Valsartan vs Enalapril on Aortic Stiffness in Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2019;322(11):1077–84. doi: 10.1001/jama.2019.12843.
- Januzzi J.L.; Prescott M.F.; Butler J.; et al. Association of Change in N-Terminal Pro-B-Type Natriuretic Peptide Following Initiation of Sacubitril-Valsartan Treatment With Cardiac Structure and Function in Patients With Heart Failure With Reduced Ejection Fraction. JAMA. 2019;322(11):1085–95. doi: 10.1001/jama.2019.12821.
- Chandra A.; Lewis E.F.; Claggett B.L.; et al. Effects of Sacubitril/Valsartan on Physical and Social Activity Limitations in Patients With Heart Failure: A Secondary Analysis of the PARADIGM-HF Trial. JAMA. Cardiol. 2018;3(6):498–505. doi: 10.1001/jamacardio.2018.0398.
- van Wijk S.W.; Ramos K.S.; Brundel B. Cardioprotective role of heat shock proteins in atrial fibrillation: From mechanism of action to therapeutic and diagnostic target. Int J Mol Sci. 2021;22:442. doi: 10.3390/ijms22010442.
- Brundel B.; Li J.; Zhang D. Role of HDACs in cardiac electropathology: Therapeutic implications for atrial fibrillation. Biochim Biophys Acta Mol Cell Res. 2020;1867:118459. doi: 10.1016/j.bbamcr.2019.03.006.
- Nattel S.; Heijman J.; Zhou L.; Dobrev D. Molecular basis of atrial fibrillation pathophysiology and therapy: A translational perspective. Circ Res. 2020;127:51–72. doi: 10.1161/CIRCRESAHA.120.316363.
- Ge Q.; Zhao L.; Ren X.M.; et al. LCZ696; an angiotensin receptor-neprilysin inhibitor; ameliorates diabetic cardiomyopathy by inhibiting inflammation; oxidative stress and apoptosis. Exp Biol Med. (Maywood). 2019;244:1028–39. doi: 10.1177/1535370219861283.
- Li S.N.; Zhang J.R.; Zhou L.; et al. Sacubitril/valsartan decreases atrial fibrillation susceptibility by inhibiting angiotensin II-Induced atrial fibrosis through p-Smad2/3; p-JNK; and p-p38 signaling pathways. J. Cardiovasc. Transl. Res. 2022;15:131–42. doi: 10.1007/s12265-021-10137-5.
- Yan J.; Thomson J.K.; Zhao W.; et al. Role of stress kinase JNK in binge alcohol-evoked atrial arrhythmia. J Am Coll Cardiol. 2018;71:1459–70. doi: 10.1016/j.jacc.2018.01.060.
- Chang P.C.; Wo H.T.; Lee H.L.; et al. Sacubitril/valsartan therapy ameliorates ventricular tachyarrhythmia inducibility in a rabbit myocardial infarction model. J Card Fail. 2020;26:527–37. doi: 10.1016/j.cardfail.2020.03.007.
- Arora R. Recent insights into the role of the autonomic nervous system in the creation of substrate for atrial fibrillation: Implications for therapies targeting the atrial autonomic nervous system. Circ Arrhythm Electrophysiol. 2012;5:850–59. doi: 10.1161/CIRCEP.112.972273.
- Chang C.M.; Wu T.J.; Zhou S.; et al. Nerve sprouting and sympathetic hyperinnervation in a canine model of atrial fibrillation produced by prolonged right atrial pacing. Circulation. 2001;103:22–5. doi: 10.1161/01.cir.103.1.22.
- Nguyen B.L.; Fishbein M.C.; Chen L.S.; et al. Histopathological substrate for chronic atrial fibrillation in humans. Heart Rhythm. 2009;6:454–60. doi: 10.1016/j.hrthm.2009.01.010.
- Li C.Y.; Li Y.G. Cardiac sympathetic nerve sprouting and susceptibility to ventricular arrhythmias after myocardial infarction. Cardiol Res Pract. 2015;2015:698368. doi: 10.1155/2015/698368.
- Voigt N.; Heijman J.; Wang Q.; et al. Cellular and molecular mechanisms of atrial arrhythmogenesis in patients with paroxysmal atrial fibrillation. Circulation. 2014;129:145–56. doi: 10.1161/CIRCULATIONAHA.113.006641.
- Nishida K.; Qi X.Y.; Wakili R.; et al. Mechanisms of atrial tachyarrhythmias associated with coronary artery occlusion in a chronic canine model. Circulation. 2011;123:137–46. doi: 10.1161/CIRCULATIONAHA.110.972778.
- Volpe M.; Carnovali M.; Mastromarino V. The natriuretic peptides system in the pathophysiology of heart failure: From molecular basis to treatment. Clin Sci (Lond). 2016;130:57–77. doi: 10.1042/CS20150469.
- Nagueh S.F.; Bhatt R.; Vivo R.P.; et al. Echocardiographic Evaluation of Hemodynamics in Patients with Decompensated Systolic Heart Failure. Circulation: Cardiovascular. Imaging. 2011;4(3):220–27. Doi: 10.1161/ CIRCIMAGING.111.963496.
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