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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Healthcare resource utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10BK) Sodium-glucose co-transporter 2 (SGLT2) inhibitors

  Sodium-glucose co-transporter 2 (SGLT2) inhibitors
• Medical condition to be studied:
  Cardiac failure

Population studied

• Short description of the study population:
  Patients with HF eligible to the SGLT2-Is dapagliflozin, regardless of diabetes (according to the DAPA-HF trial’s eligibility criteria) were identified from the Health Search primary care database and from the Fondazione ReS administrative database
• Age groups:
  • Adult and elderly population (≥18 years)

Study design details

• Study design:
  Retrospective longitudinal cohort study
• Main study objective:
  To identify and characterize HF-patients eligible to SGLT2-I, and; assess their costs charged to the Italian National Health Service (SSN)
• Setting:
  In-hospital and local outpatient setting in public and affiliated with SSN facilities, as regards the Database of Fondazione ReS.; Primary care as regards the Health Search database
• Summary results:
  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).