Effectiveness of SGLT2 Inhibitors in Patients With Heart Failure: Real-World Cohort Study.

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  DAPAGLIFLOZIN
• Name of medicine, other:
  Empagliflozin
• Study drug International non-proprietary name (INN) or common name:
  DAPAGLIFLOZIN

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

  Sodium-glucose co-transporter 2 (SGLT2) inhibitors

  (A10BK01) dapagliflozin

  dapagliflozin

  (A10BK03) empagliflozin

  empagliflozin
• Additional medical condition(s):
  Heart Failure

Population studied

• Short description of the study population:
  Patients from the database; - aged > 18 years; - with first heart failure related hospitalization between 2021 and 2023; - with no history of organ transplantation, renal chronic failure or cancer/hematologic disease prior to inclusion
• 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)
• Estimated number of subjects:
  270000

Study design details

• Study design:
  Cohort study based on administrative data (French National Health Database).
• Main study objective:
  The main objective of the study is to determine, in heart failure individuals, the effectiveness of gliflozins combined with standard heart failure medication compared to standard heart failure medication alone on the combined risk of hospitalization for heart failure and all-cause mortality.
• Setting:
  Inclusion criteria: ; Patients aged >18 years hospitalized between 2021 and 2023 for a first episode of heart failure.; ; Exclusion criteria: ; Individuals hospitalized for heart failure in the 2 years preceding inclusion. ; Individuals treated with left ventricular mechanical assistance or cardiac transplantation during the first hospitalization for heart failure. ; Individuals with a history of organ transplantation, chronic renal failure or cancer/hematological disease before inclusion.; Individuals readmitted for any reason within 30 days following the index hospitalization. ; ; Exposure:; Exposure will be defined according to a per-protocol model: individuals will be considered exposed if they receive a dispensing of empagliflozin or dapagliflozin within 30 days following discharge from hospital and will be censored in case of treatment discontinuation. Treatment discontinuation will be considered effective if there is a gap of more than 60 days between two dispensings. Individuals who have not received a dispensing of gliflozin within the first 30 days following inclusion will be considered unexposed and will be censored on the date of first dispensing in case of treatment initiation.
• Comparators:
  Standard of care in heart failure (ie. betablockers, ACE inhibitors, MRA inhibitors and sacubitril/valsartan)
• Outcomes:
  Hospitalization for heart failure and all-cause mortality during follow-up.
• Data analysis plan:
  Main analysis according to the per-protocol model. Development of a CTS (calendar time specific) propensity score with 1:1 matching using the nearest neighbor method. Survival analysis using the Kaplan-Meier method, estimation of relative risks using a Cox model.