Position paper ANMCO sull'utilizzo della terapia con sacubitril/valsartan nel paziente con scompenso cardiaco

Giuseppe Di Tano, Andrea Di Lenarda, Domenico Gabrielli, Nadia Aspromonte, Renata De Maria, Maria Frigerio, Massimo Iacoviello, Andrea Mortara, Adriano Murrone, Federico Nardi, Fabrizio Oliva, Roberto Pontremoli, Marino Scherillo, Michele Senni, Stefano Urbinati, Michele Massimo Gulizia

Research output: Contribution to journalReview article

Abstract

Sacubitril/valsartan, the first-in-class angiotensin receptor neprilysin inhibitor (ARNI), is the first medication to demonstrate a mortality benefit in patients with chronic heart failure and reduced ejection fraction (HFrEF) since the early 2000s. Sacubitril/valsartan simultaneously suppresses renin-angiotensin-aldosterone system activation through blockade of angiotensin II type 1 receptors and enhances the activity of vasoactive peptides including natriuretic peptides, through inhibition of neprilysin, the enzyme responsible for their degradation. In the landmark PARADIGM-HF trial, patients with HFrEF treated with sacubitril/ valsartan had a 20% reduction in the primary composite endpoint of cardiovascular death or heart failure hospitalization, a 20% lower risk of cardiovascular death, a 21% to 20% lower risk of a first heart failure hospitalization, and a 16% to 20% lower risk of death from any cause, compared with subjects allocated to enalapril (all p<0.001). Following the trial, new international guidelines endorsed sacubitril/valsartan as a class I recommendation for the management of patients with HFrEF who remain symptomatic despite optimal medical management. In Italy, sacubitril/valsartan is reimbursed by the National Health Service since March 2017 within criteria set by the Italian Medicines Agency subject to patient inclusion in a dedicated monitoring registry. Although numerous post-hoc analyses of the original trial suggested that the benefits of this innovative medication may extend across a variety of subgroups, many questions do not yet have an evidence-based answer. In this position paper, we discuss the current role of sacubitril/valsartan in the management of chronic HFrEF, treatment eligibility and the modulating role of patients' characteristics. Moreover, we address concerns elicited by the PARADIGM-HF study and shortcomings of this novel drug, to clarify the place of this new therapy in the context of global care of heart failure in Italy. Our aim is to provide clinical cardiologists with a concise and practical guidance on when and how to use sacubitril/valsartan, to assist clinicians in closing the gap between scientific innovation and real-world experience.

Original languageItalian
Pages (from-to)568-590
Number of pages23
JournalGiornale Italiano di Cardiologia
Volume19
Issue number10
Publication statusPublished - Oct 1 2018

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Di Tano, G., Di Lenarda, A., Gabrielli, D., Aspromonte, N., De Maria, R., Frigerio, M., ... Gulizia, M. M. (2018). Position paper ANMCO sull'utilizzo della terapia con sacubitril/valsartan nel paziente con scompenso cardiaco. Giornale Italiano di Cardiologia, 19(10), 568-590.

Position paper ANMCO sull'utilizzo della terapia con sacubitril/valsartan nel paziente con scompenso cardiaco. / Di Tano, Giuseppe; Di Lenarda, Andrea; Gabrielli, Domenico; Aspromonte, Nadia; De Maria, Renata; Frigerio, Maria; Iacoviello, Massimo; Mortara, Andrea; Murrone, Adriano; Nardi, Federico; Oliva, Fabrizio; Pontremoli, Roberto; Scherillo, Marino; Senni, Michele; Urbinati, Stefano; Gulizia, Michele Massimo.

In: Giornale Italiano di Cardiologia, Vol. 19, No. 10, 01.10.2018, p. 568-590.

Research output: Contribution to journalReview article

Di Tano, G, Di Lenarda, A, Gabrielli, D, Aspromonte, N, De Maria, R, Frigerio, M, Iacoviello, M, Mortara, A, Murrone, A, Nardi, F, Oliva, F, Pontremoli, R, Scherillo, M, Senni, M, Urbinati, S & Gulizia, MM 2018, 'Position paper ANMCO sull'utilizzo della terapia con sacubitril/valsartan nel paziente con scompenso cardiaco', Giornale Italiano di Cardiologia, vol. 19, no. 10, pp. 568-590.
Di Tano, Giuseppe ; Di Lenarda, Andrea ; Gabrielli, Domenico ; Aspromonte, Nadia ; De Maria, Renata ; Frigerio, Maria ; Iacoviello, Massimo ; Mortara, Andrea ; Murrone, Adriano ; Nardi, Federico ; Oliva, Fabrizio ; Pontremoli, Roberto ; Scherillo, Marino ; Senni, Michele ; Urbinati, Stefano ; Gulizia, Michele Massimo. / Position paper ANMCO sull'utilizzo della terapia con sacubitril/valsartan nel paziente con scompenso cardiaco. In: Giornale Italiano di Cardiologia. 2018 ; Vol. 19, No. 10. pp. 568-590.
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AU - Aspromonte, Nadia

AU - De Maria, Renata

AU - Frigerio, Maria

AU - Iacoviello, Massimo

AU - Mortara, Andrea

AU - Murrone, Adriano

AU - Nardi, Federico

AU - Oliva, Fabrizio

AU - Pontremoli, Roberto

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AU - Senni, Michele

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N2 - Sacubitril/valsartan, the first-in-class angiotensin receptor neprilysin inhibitor (ARNI), is the first medication to demonstrate a mortality benefit in patients with chronic heart failure and reduced ejection fraction (HFrEF) since the early 2000s. Sacubitril/valsartan simultaneously suppresses renin-angiotensin-aldosterone system activation through blockade of angiotensin II type 1 receptors and enhances the activity of vasoactive peptides including natriuretic peptides, through inhibition of neprilysin, the enzyme responsible for their degradation. In the landmark PARADIGM-HF trial, patients with HFrEF treated with sacubitril/ valsartan had a 20% reduction in the primary composite endpoint of cardiovascular death or heart failure hospitalization, a 20% lower risk of cardiovascular death, a 21% to 20% lower risk of a first heart failure hospitalization, and a 16% to 20% lower risk of death from any cause, compared with subjects allocated to enalapril (all p<0.001). Following the trial, new international guidelines endorsed sacubitril/valsartan as a class I recommendation for the management of patients with HFrEF who remain symptomatic despite optimal medical management. In Italy, sacubitril/valsartan is reimbursed by the National Health Service since March 2017 within criteria set by the Italian Medicines Agency subject to patient inclusion in a dedicated monitoring registry. Although numerous post-hoc analyses of the original trial suggested that the benefits of this innovative medication may extend across a variety of subgroups, many questions do not yet have an evidence-based answer. In this position paper, we discuss the current role of sacubitril/valsartan in the management of chronic HFrEF, treatment eligibility and the modulating role of patients' characteristics. Moreover, we address concerns elicited by the PARADIGM-HF study and shortcomings of this novel drug, to clarify the place of this new therapy in the context of global care of heart failure in Italy. Our aim is to provide clinical cardiologists with a concise and practical guidance on when and how to use sacubitril/valsartan, to assist clinicians in closing the gap between scientific innovation and real-world experience.

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