Heart Failure
Conditions
Brief summary
Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic heart failure (CHF) under real-world use.
Interventions
DRUGJARDIANCE®
Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS).
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with chronic heart failure (CHF) failure 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Adverse Drug Reactions (ADRs) | Up to 52 weeks | Number of subjects with ADRs (focus on hypoglycaemia, the events relevant for volume depletion, influence of ketone body increased / ketoacidosis, renal impairment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of All-cause Death | Up to 52 weeks | Incidence of all-cause death. |
| Incidence of Cardiovascular Death | Up to 52 weeks | Incidence of cardiovascular death. |
| Incidence of Hospitalizations for Heart Failure | Up to 52 weeks | Incidence of hospitalizations for heart failure. |
Countries
Japan
Participant flow
Recruitment details
All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Pre-assignment details
This was a 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. Out of the 1200 registered subjects, 1166 had no protocol violations and were included in the safety set.
Participants by arm
| Arm | Count |
|---|---|
| JARDIANCE® Patients in Japan with chronic heart failure who were prescribed JARDIANCE® (Empagliflozin) tablets and who were never treated with Empagliflozin before enrolment (including treatment for type 2 diabetes mellitus). Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS). Patients were observed for up to 52 weeks after start of the treatment or until discontinuation of administration. | 1,166 |
| Total | 1,166 |
Baseline characteristics
| Characteristic | JARDIANCE® |
|---|---|
| Age, Continuous | 74.9 years STANDARD_DEVIATION 12.4 |
| Sex: Female, Male Female | 455 Participants |
| Sex: Female, Male Male | 711 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 30 / 1,166 |
| other Total, other adverse events | 0 / 1,166 |
| serious Total, serious adverse events | 148 / 1,166 |
Outcome results
Primary
Number of Subjects With Adverse Drug Reactions (ADRs)
Number of subjects with ADRs (focus on hypoglycaemia, the events relevant for volume depletion, influence of ketone body increased / ketoacidosis, renal impairment).
Time frame: Up to 52 weeks
Population: Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| JARDIANCE® | Number of Subjects With Adverse Drug Reactions (ADRs) | 61 Participants |
Secondary
Incidence of All-cause Death
Incidence of all-cause death.
Time frame: Up to 52 weeks
Population: Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JARDIANCE® | Incidence of All-cause Death | 3.01 Deaths per 100 person-years |
Secondary
Incidence of Cardiovascular Death
Incidence of cardiovascular death.
Time frame: Up to 52 weeks
Population: Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JARDIANCE® | Incidence of Cardiovascular Death | 0.90 Deaths per 100 person-years |
Secondary
Incidence of Hospitalizations for Heart Failure
Incidence of hospitalizations for heart failure.
Time frame: Up to 52 weeks
Population: Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JARDIANCE® | Incidence of Hospitalizations for Heart Failure | 2.53 1st Hospitalization per 100 person-years |