Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medicinal product name

JARDIANCE

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

EMPAGLIFLOZIN

Anatomical Therapeutic Chemical (ATC) code

(A10BK03) empagliflozin
empagliflozin

Medical condition to be studied

Cardiac failure
Cardiac failure chronic
Population studied

Short description of the study population

Inclusion criteria
- Patients with CHF who are prescribed with JARDIANCE® Tablets in
Japan.
- Patients who have never been treated with Empagliflozin (including
treatment for type 2 diabetes mellitus [T2DM]) before enrolment.
Exclusion criteria
- None

Age groups

  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • 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

1200
Study design details

Study design

Cohort study
Non-interventional, single arm study based on newly collected data. Patients were observed for up to 52 weeks after start of the treatment with JARDIANCE® Tablets or until discontinuation of administration.

Main study objective

Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic heart failure under real-world use.

Setting

Sites throughout entire country were equally listed according to the size of the hospitals or general clinics at which JARDIANCE® Tablets were available for prescription. Planned number of sites: Approximately 200 Sites (including
cardiovascular [CV] internal medicine A medical representative explained the objective and design of this study
to investigators at each study site and concluded a written contract with the head of the study site (e.g., hospital director). This study was conducted in 146 centres in Japan.
Study period: April 2022 – Jun 2024
Enrollment period: April 2022 – Mar 2023

Outcomes

Primary outcome:
- Incidence of adverse drug reactions (ADRs) (focus on hypoglycaemia,
the events relevant to volume depletion, influence of ketone body
increased / ketoacidosis, renal impairment)
Secondary outcome:
- Incidence of all-cause death
- Incidence of CV death
- Incidence of hospitalizations for heart failure (HF)
Further outcome:
Other safety outcomes;
- Incidences of serious adverse events (SAEs)
- Time to all-cause death, CV death and hospitalization for HF
- Change from baseline in eGFR over time
- Baseline characteristics

Data analysis plan

Analyses are descriptive in nature, including confidence intervals.