Impact of SGLT2i on Rates of Heart Failure Hospitalizations in France: an Interrupted Times Series

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Interrupted Time Series

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DAPAGLIFLOZIN

  EMPAGLIFLOZIN
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BK01) dapagliflozin

  dapagliflozin

  (A10BK03) empagliflozin

  empagliflozin
• Medical condition to be studied:
  Heart failure with midrange ejection fraction

  Heart failure with preserved ejection fraction

  Heart failure with reduced ejection fraction

Population studied

• Short description of the study population:
  Patients > 18 years, with heart failure
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Renal impaired
• Special population of interest, other:
  Diabetes
• Estimated number of subjects:
  650000

Study design details

• Study design:
  This study is an interrupted time series between 2016 and 2024.
• Main study objective:
  The main objective of this study is to assess populational impact of SGLT2i release in France (April 2020) on rates of heart failure hospitalizations, in patients with history of heart failure.
• Setting:
  Patients with history of heart failure will be included. HF will by defined by the following criteria : ; 1/ Hospitalization for HF in the past 5 years; 2/ Hospitalization for HF complication in the past 5 years; 3/ Hospitalization for other condition, with related diagnosis of HF in the past year; 4/ Hospitalization for HF in rehabilitation care, in the past year; 5/ Ongoing Long Term Disease reimbursement for HF ; ; ; Intervention date will be set at the release of SGLT2i in France, which was on April 2020.
• Comparators:
  This design has no comparator group.
• Outcomes:
  Times series will be the following :; 1/ Monthly rates of SGLT2i exposure (defined by at least one delievery of SGLT2i); 2/ Monthly rates of HHF (defined by unplanned hospitalization for HF);