The real‐world evidence of heart failure: findings from 41 413 patients of the <scp>ARNO</scp> database

<jats:title>Abstract</jats:title><jats:sec><jats:title>Aims</jats:title><jats:p>Patients with heart failure (<jats:styled-content style="fixed-case">HF</jats:styled-content>) 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 <jats:styled-content style="fixed-case">HF</jats:styled-content> by analysing administrative data of a population of nearly 2 500 000 subjects.</jats:p></jats:sec><jats:sec><jats:title>Methods and results</jats:title><jats:p>Data came from the <jats:styled-content style="fixed-case">ARNO</jats:styled-content> Observatory including inhabitants of five Local Health Units of the Italian National Health Service (<jats:styled-content style="fixed-case">INHS</jats:styled-content>). Patients were selected when discharged for <jats:styled-content style="fixed-case">HF</jats:styled-content> (1 January 2008–31 December 2012) and prescribed at least one <jats:styled-content style="fixed-case">HF</jats:styled-content> treatment. Clinical characteristics, pharmacological treatments, rehospitalization, and direct costs for the <jats:styled-content style="fixed-case">INHS</jats:styled-content> were described during 1‐year follow‐up (<jats:styled-content style="fixed-case">FU</jats:styled-content>). Of the 2 456 739 subjects included in the database, 54 059 (2.2%) were hospitalized for <jats:styled-content style="fixed-case">HF</jats:styled-content>: 41 413 were discharged alive and prescribed <jats:styled-content style="fixed-case">HF</jats:styled-content> 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%), <jats:styled-content style="fixed-case">COPD</jats:styled-content> (30.5%), and depression (21%). <jats:styled-content style="fixed-case">ACE</jats:styled-content> inhibitors/<jats:styled-content style="fixed-case">ARBs</jats:styled-content>, beta‐blockers, and mineralocorticoid antagonists were prescribed in 65.8, 49.7, and 42.1% of patients, respectively. During 1‐year <jats:styled-content style="fixed-case">FU</jats:styled-content>, 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 <jats:styled-content style="fixed-case">INHS</jats:styled-content> was €11 867, of which 76% was related to hospitalizations.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>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 <jats:styled-content style="fixed-case">INHS</jats:styled-content> are mainly driven by hospitalizations, which are often due to non‐cardiovascular reasons.</jats:p></jats:sec>