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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000259
• EU PAS number:
  EUPAS1000000259
• Study ID:
  1000000259
• Official title and acronym:
  How many and who are patients with heart failure eligible to SGLT2 inhibitors? Responses from the combination of administrative healthcare and primary care databases
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Fondazione ReS (Ricerca e Salute), CINECA partner

Italy

Health Search, Italian College of General Practicioners

Italy

Study timelines

Date when funding contract was signed

Actual: 12/01/2022

Study start date

Actual: 10/02/2022

Date of final study report

Actual: 02/04/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astra Zeneca SpA

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable