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How many and who are patients with heart failure eligible to SGLT2 inhibitors? Responses from the combination of administrative healthcare and primary care databases

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    Carlo Piccinni
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    Fondazione ReS (Ricerca e Salute – Health and Research Foundation), Rome, Italy
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    Letizia Dondi
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    Fondazione ReS (Ricerca e Salute – Health and Research Foundation), Rome, Italy
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    Silvia Calabria
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    Corresponding author at: Fondazione ReS (Ricerca e Salute) – Research and Health Foundation, via dei Due Macelli, 48, 00187 Rome, Italy.
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    Giulia Ronconi
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    Fondazione ReS (Ricerca e Salute – Health and Research Foundation), Rome, Italy
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    Antonella Pedrini
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    Francesco Lapi
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    Health Search - Istituto di Ricerca della S.I.M.G, Firenze, Italy
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    Ettore Marconi
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    Health Search - Istituto di Ricerca della S.I.M.G, Firenze, Italy
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    Damiano Parretti
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    Gerardo Medea
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    Claudio Cricelli
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    Nello Martini
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    Aldo Pietro Maggioni
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    Fondazione ReS (Ricerca e Salute – Health and Research Foundation), Rome, Italy

    ANMCO Research Center Heart Care Foundation, Firenze, Italy
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Published:September 26, 2022DOI:https://doi.org/10.1016/j.ijcard.2022.09.053

      Highlights

      • Half of patients with HF have reduced ejection fraction (HFrEF), but few claims data studies tried to analyze them.
      • Patients with HF eligible to SGLT2-Is(HFrEF) are analyzed through Italian primary care and administrative databases
      • From this study, 20% patients with HF are eligible to SGLT2-Ibased on DAPA-HF trial’s criteria.
      • High comorbidity rates (>90%), frequent cause of HF hospitalization(e.g. diabetes), are consistent between the databases.
      • A slightly higher mean annual cost per patient with HF eligible to SGLT2-Is (vs general HF population) is found.

      Abstract

      Background

      Recent successful findings (i.e. DAPA-HF trial) in patients with heart failure (HF) with/without diabetes treated with sodium-glucose co-transporter inhibitors (SGLT2-I) have fostered real-world data analyses. Fondazione Ricerca e Salute's (ReSD) administrative and Health Search's (HSD) primary healthcare databases were combined in the ReS-HS DB Consortium, to identify and characterize HF-patients eligible to SGLT2-I, and assess their costs charged to the Italian National Health Service (INHS).

      Methods and results

      Eligibility to SGLT2-I was HF diagnosis, age ≥ 18 years, reduced (≤40%) ejection fraction (HFrEF) and glomerular filtration rate (GFR) ≥30 ml/min. The HSD, including 13,313 HF-patients (1.5% of the total HSD population) was used to develop and test the algorithms for imputing HFrEF and GFR ≥ 30 ml/min, based on a set of covariates, to the ReSD, including 67,369 (1.5% of the total ReSD population). Subjects eligible to SGLT2-I were 2187 in HSD (61.1% of HFrEF); after the imputation, 15,145 in ReSD (58.8% of HFrEF). Prevalence of eligibility to SGLT2-I was higher in males then in females and increased with age; diabetic patients were 44.3% and 33.4% of HSD and ReSD populations eligible to SGLT2-I, respectively. Estimated from ReSD, the mean annual cost charged to the INHS per patient with HF eligible to SGLT2-I was €7122 (68% due to hospitalizations).

      Conclusions

      Approximately 20% of patients with HF was eligible to SGLT2-I. Real-world data can identify, quantify and characterize patients eligible to SGLT2-Is and assess related costs for the health care system, thus providing useful information to Regulatory Decision makers.

      Keywords

      Abbreviations:

      ATC (Anatomical Therapeutic Chemical), CV (Cardiovascular), EF (Ejection Fraction), GFR (Glomerular Filtration Rate), GP (General Practitioner), HSD (Health Search's primary care database), HF (Heart Failure), HFrEF (Heart Failure with Reduced Ejection Fraction), ICD-9-CM (International Classification of Diseases - 9th Revision - Clinical Modification), INHS (Italian National Health Service), LHA (Local Healthcare Authority), ReSD (Fondazione Ricerca e Salute's database), RHA (Regional Healthcare Authority), SGLT2-I (Sodium-Glucose Transporter 2 Inhibitor)
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