Aims Patients with heart failure (HF) randomized in controlled trials are generally selected and do not fully represent the ‘real world’. The purpose of this study is to better describe the characteristics of HF by analysing administrative data of a population of nearly 2 500 000 subjects. Methods and results Data came from the ARNO Observatory including inhabitants of five Local Health Units of the Italian National Health Service (INHS). Patients were selected when discharged for HF (1 January 2008–31 December 2012) and prescribed at least one HF treatment. Clinical characteristics, pharmacological treatments, rehospitalization, and direct costs for the INHS were described during 1‐year follow‐up (FU). Of the 2 456 739 subjects included in the database, 54 059 (2.2%) were hospitalized for HF: 41 413 were discharged alive and prescribed HF treatments. Mean age was 78 ± 11 years and 51.4% were females. Just 26.6% were managed in a cardiology setting. The most frequent co‐morbidities were diabetes (30.7%), COPD (30.5%), and depression (21%). ACE inhibitors/ARBs, beta‐blockers, and mineralocorticoid antagonists were prescribed in 65.8, 49.7, and 42.1% of patients, respectively. During 1‐year FU, at least one rehospitalization occurred in 56.6% of patients, 49% of them due to non‐cardiovascular causes. The direct cost per patient per year to the INHS was €11 867, of which 76% was related to hospitalizations. Conclusions Real‐world evidence provides a description of patient characteristics and treatment patterns that are different from those reported by randomized clinical trials. Costs for the INHS are mainly driven by hospitalizations, which are often due to non‐cardiovascular reasons.

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PurposeHepatic encephalopathy (HE) is a recurrent severe complication of progressive hepatic cirrhosis. The aim of this study is to evaluate the average annual direct healthcare costs for the treatment of patients with overt HE in Italy.Patients and methodsThis retrospective, observational study analyzed information from the database of ARNO Observatory. Patients with at least one hospitalization due to overt HE in the period from January 1, 2011 to December 31, 2011, were selected and observed during the year following the hospitalization. Costs for drugs, diagnostic and therapeutic procedures, and hospitalizations were estimated from the Italian National Health Service perspective.ResultsOut of a population of 2,678,462 subjects, 381 patients were identified, of whom, 21.5% died during the first hospitalization and 5.8% during the follow-up; the survival rate was 72.7% at the end of the observation period. The direct healthcare costs per patient amounted to €13,393/year (15,295 USD) (88% for hospitalizations, 8% for drugs, and 4% for diagnostic procedures). During the follow-up, 42.5% of patients had at least one rehospitalization due to HE. Patients readmitted for HE had an average annual cost of €21,272 (24,293 USD), almost doubled if compared to patients without readmissions (€12,098 [13,816 USD]).ConclusionThis analysis showed that patients with HE had relevant direct healthcare costs, in which hospitalizations were the most important cost drivers.