Empagliflozin effectiveness in a real-world population replicating the DECLARE - TIMI58 trial

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  EMPAGLIFLOZIN
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  24000

Study design details

• Main study objective:
  This study aims to evaluate the effect of empagliflozin on cardiovascular events and mortality in a real-world population aligned with the trial population of the Dapagliflozin Effect on Cardiovascular Events (DECLARE) - TIMI58 cardiovascular outcome trial using real-world data.
• Outcomes:
  Primary outcomes: MI, stroke, mortality, Secondary outcomes: HF hospitalization, HF hospitalization or mortality
• Data analysis plan:
  We will perform propensity-score (PS) matching and follow patients for each of the outcomes of interest, and estimate measures of effect using person-time based analyses among patients who initiate empagliflozin versus active comparator initiators (e.g. DPP4-i, GLP-1RA). In the adjusted analyses, we will use propensity score (PS) matching to balance potential confounders. Hazard ratios will be estimated for unmatched and PS-matched population.