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OBJECTIVES We report 1-year safety and clinical outcomes in patients

[Italiano]: Una delle sfide che ha maggiormente segnato il dibattito pubblico degli ultimi anni ha riguardato lo sforzo di salvaguardare la sostenibilità dell’assistenza sanitaria in relazione al cambiamento demografico. Il progressivo invecchiamento della popolazione, nonché la tendenziale cronicizzazione delle malattie, richiede l’impiego di metodiche di cura con requisiti tecnologici-assistenziali sempre più avanzati e costosi, che in Italia gravano e mettono in difficoltà, sia da un punto di vista sanitario sia economico, il Sistema Sanitario Nazionale. Tale criticità è emersa anche durante la pandemia da COVID-19, comprovando la necessità di ripensare al modello di gestione della cronicità, ancora troppo centrato su una prospettiva specialistica e/o ospedaliera, per renderlo più idoneo a rispondere alle problematiche assistenziali dei pazienti nel rispetto delle risorse economiche disponibili. A questo proposito, può risultare di grande interesse l’Outcome Research, intesa come area di ricerca che si avvale della Real World Evidence (RWE), poiché dalle analisi delle evidenze prodotte nel mondo reale è possibile confermare o meno la validità delle decisioni politiche attuate al fine di migliorare la governance e la qualità dei servizi erogati. Questo lavoro intende proporre una fotografia dettagliata della prevalenza delle patologie croniche, e delle relative comorbidità, in Regione Campania ma, nel contempo, vuole anche essere un efficace strumento di conoscenze a disposizione di quei decisori impegnati nella programmazione delle politiche e delle strategie sanitarie. /[English]: One of the main challenges in the healthcare sector in recent years has concerned the effort to ensure the healthcare sustainability in view of demographic change. Due to the progressive increasing of aging and chronic conditions, it is necessary to employ treatment methods with increasingly advanced and costly technological and care requirements that the Italian Health System has to deal with both from a health and economic standpoint. This critical issue also emerged during the COVID-19 pandemic, proving the need to reconsider the management of chronic conditions, which is still too focused on a specialist and/or hospital perspective, to make it more suitable for responding to patients' care issues while respecting available economic resources. In this regard, Outcome Research is of great interest as a research area based on Real World Evidences (RWE). Indeed, analyses of evidence produced in a Real-World context can confirm or not the value of political decision-making to improve governance and the quality of health-services provided. The aim of this work is to provide a detailed snapshot of the prevalence of chronic diseases and related comorbidities in Campania Region. At the same time, it also aims to be an effective knowledge tool for decision-makers involved in the planning of health policies and strategies.

Una delle sfide che ha maggiormente segnato il dibattito pubblico degli ultimi anni ha riguardato lo sforzo di salvaguardare la sostenibilit�� dell���assistenza sanitaria in relazione al cambiamento demografico. Il progressivo invecchiamento della popolazione, nonch�� la tendenziale cronicizzazione delle malattie, richiede l���impiego di metodiche di cura con requisiti tecnologici-assistenziali sempre pi�� avanzati e costosi, che in Italia gravano e mettono in difficolt��, sia da un punto di vista sanitario sia economico, il Sistema Sanitario Nazionale. Tale criticit�� �� emersa anche durante la pandemia da COVID-19, comprovando la necessit�� di ripensare al modello di gestione della cronicit��, ancora troppo centrato su una prospettiva specialistica e/o ospedaliera, per renderlo pi�� idoneo a rispondere alle problematiche assistenziali dei pazienti nel rispetto delle risorse economiche disponibili. A questo proposito, pu�� risultare di grande interesse l���Outcome Research, intesa come area di ricerca che si avvale della Real World Evidence (RWE), poich�� dalle analisi delle evidenze prodotte nel mondo reale �� possibile confermare o meno la validit�� delle decisioni politiche attuate al fine di migliorare la governance e la qualit�� dei servizi erogati. Questo lavoro intende proporre una fotografia dettagliata della prevalenza delle patologie croniche, e delle relative comorbidit��, in Regione Campania ma, nel contempo, vuole anche essere un efficace strumento di conoscenze a disposizione di quei decisori impegnati nella programmazione delle politiche e delle strategie sanitarie., One of the main challenges in the healthcare sector in recent years has concerned the effort to ensure the healthcare sustainability in view of demographic change. Due to the progressive increasing of aging and chronic conditions, it is necessary to employ treatment methods with increasingly advanced and costly technological and care requirements that the Italian Health System has to deal with both from a health and economic standpoint. This critical issue also emerged during the COVID-19 pandemic, proving the need to reconsider the management of chronic conditions, which is still too focused on a specialist and/or hospital perspective, to make it more suitable for responding to patients' care issues while respecting available economic resources. In this regard, Outcome Research is of great interest as a research area based on Real World Evidences (RWE). Indeed, analyses of evidence produced in a Real-World context can confirm or not the value of political decision-making to improve governance and the quality of health-services provided. The aim of this work is to provide a detailed snapshot of the prevalence of chronic diseases and related comorbidities in Campania Region. At the same time, it also aims to be an effective knowledge tool for decision-makers involved in the planning of health policies and strategies.

Supplementary material

Claudio Napoli,1 Paola Bontempo,2 Vittorio Palmieri,3 Enrico Coscioni,4 Ciro Maiello,5 Francesco Donatelli,6 Giuditta Benincasa1 1Department of Advanced Medical and Surgical Sciences (DAMSS), University of Campania “Luigi Vanvitelli”, Naples, 80138, Italy; 2Department of Precision Medicine, University of Campania “Luigi Vanvitelli”, Naples, 80138, Italy; 3Department of Cardiac Surgery and Transplantation, Heart Transplantation Unit in Adults of the ‘Ospedali dei Colli Monaldi-Cotugno-CTO’, Naples, Italy; 4Department of Cardiac Surgery, Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d’Aragona, Salerno, Italy; 5Department of Cardiovascular Surgery and Transplants, Monaldi Hospital, Azienda dei Colli, Naples, Italy; 6Chair of Cardiac Surgery, Department of Cardiothoracic Center, Istituto Clinico Sant’Ambrogio, University of Milan, Milan, ItalyCorrespondence: Giuditta BenincasaDepartment of Advanced Medical and Surgical Sciences (DAMSS), University of Campania “Luigi Vanvitelli”, Naples, ItalyTel +390815667916Email giuditta.benincasa@unicampania.itAbstract: Despite the current reductionist approach providing an optimal indication for diagnosis and treatment of patients with heart failure with reduced ejection fraction (HFrEF), there are no standard pharmacological therapies for heart failure with preserved ejection fraction (HFpEF). Although in its infancy in cardiovascular diseases, the epigenetic-based therapy (“epidrugs”) is capturing the interest of physician community. In fact, an increasing number of controlled clinical trials isevaluating the putative beneficial effects of: 1) direct epigenetic-oriented drugs, eg, apabetalone, and 2) repurposed drugs with a possible indirect epigenetic interference, eg, metformin, statins, sodium glucose transporter inhibitors 2 (SGLT2i), and omega 3 polyunsaturated fatty acids (PUFAs) in both HFrEF and HFpEF, separately. Apabetalone is the first and unique direct epidrug tested in cardiovascular patients to date, and the BETonMACE trial has reported a reduction in first HF hospitalization (any EF value) and cardiovascular death in patients with type 2 diabetes and recent acute coronary syndrome, suggesting a possible role in secondary prevention. Patients with HFpEF seem to benefit from supplementation to the standard therapy with statins, metformin, and SGLT2i owing to their ability in reducing mortality. In contrast, the vasodilator hydralazine, with or without isosorbide dinitrate, did not provide beneficial effects. In HFrEF, metformin and SGLT2i could reduce the risk of incident HF and mortality in affected patients whereas clinical trials based on statins provided mixed results. Furthermore, PUFAs diet supplementation was significantly associated with reduced cardiovascular risk in both HFpEF and HFrEF. Future large trials will reveal whether direct and indirect epitherapy will remain a work in progress or become a useful way to customize the therapy in the real-world management of HFpEF and HFrEF. Our goal is to discuss the recent advancement in the epitherapy as a possible way to improve personalized therapy of HF.Keywords: heart failure, personalized therapy, epidrugs