Non-interventional study of the effectiveness and safety of Jardiance in patients with heart failure (HF) of reduced ejection fraction (HFrEF) compared to guideline-recommended non- SGLT2i therapy regimens in China: A sub-study of the postmarketing study of Jardiance among patients with heart failure in China

Study type

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

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  JARDIANCE

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:
  5000

Study design details

• Main study objective:
  To provide the effectiveness and safety evidence in patients with HFrEF initiating Jardiance in real clinical practice in a larger Chinese population.Primary Objective:To compare the risk of the composite outcome of Cardiovascular (CV) death or HHF in HFrEF patients initiating Jardiance with propensity score (PS) matched HFrEF patients initiating guideline-recommended non-SGLT2i medications.
• Outcomes:
  Time from the index date to the first HHF or CV death, -Time from the index date to CV death -Time from the index date to the first HHF -Total number of HHFs at 30 days after the index date -Total number of HHFs at 90 days after the index date -Total number of HHFs at 1 year after the index date -Time from the index date to all-cause death
• Data analysis plan:
  Matching: All collected baseline patient characteristics, including drug class distribution, in each exposure group (including the comparability between Jardiance and each comparator drug class) will be tabulated and described before and after PSM matching. If there still are covariates not meeting the 0.1 threshold after matching, they will be adjusted in the regression model described below. Risk estimation: for each of the time to event outcomes, multivariate adjusted hazard ratio and corresponding 95% confidence intervals (CI) will be estimated in the PS-matched cohorts using Cox regression model. Kaplan-Meier curves will also be produced. Total number of HHFs at 30, 90 days and 1 year after the index date will be analysed using Negative Binomial regression. Rate ratio and corresponding 95% CI will be estimated using the PS-matched cohorts.