Trial Outcomes & Findings for Jardiance® Post Marketing Surveillance (PMS) in Korean Patients With Chronic Heart Failure (NCT NCT05236673)
NCT ID: NCT05236673
Last Updated: 2026-08-10
Results Overview
Number of patients with unexpected adverse drug reaction in JARDIANCE® treated patients is reported.
COMPLETED
676 participants
Up to 407 days.
2026-08-10
Participant Flow
This was a single-arm, open-label, multicenter, observational, non-interventional study to monitor the safety profile and efficacy of Jardiance® in Korean patients with Chronic Heart Failure (New York Heart Association (NYHA) class II-IV).
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. Out of the 676 enrolled subjects, 47 subjects were not included in the safety set.
Participant milestones
| Measure |
JARDIANCE® Treated Patients
Patients in Korea 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).
|
|---|---|
|
Overall Study
STARTED
|
629
|
|
Overall Study
COMPLETED
|
629
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
JARDIANCE® Treated Patients
n=629 Participants
Patients in Korea 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).
|
|---|---|
|
Age, Continuous
|
66.2 Years
STANDARD_DEVIATION 14.68 • n=629 Participants
|
|
Sex: Female, Male
Female
|
241 Participants
n=629 Participants
|
|
Sex: Female, Male
Male
|
388 Participants
n=629 Participants
|
PRIMARY outcome
Timeframe: Up to 407 days.Population: Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more for up to 24 weeks of follow up.
Number of patients with adverse events (AEs) is reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=629 Participants
Patients in Korea 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).
|
|---|---|
|
Number of Patients With Adverse Events (AEs)
|
116 Participants
|
PRIMARY outcome
Timeframe: Up to 407 days.Population: Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more for up to 24 weeks of follow up.
Number of patients with unexpected adverse events is reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=629 Participants
Patients in Korea 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).
|
|---|---|
|
Number of Patients With Unexpected Adverse Events
|
39 Participants
|
PRIMARY outcome
Timeframe: Up to 407 days.Population: Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more for up to 24 weeks of follow up.
Number of patients with unexpected adverse drug reaction in JARDIANCE® treated patients is reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=629 Participants
Patients in Korea 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).
|
|---|---|
|
Number of Patients With Unexpected Adverse Drug Reaction
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 407 days.Number of patients with serious adverse events is reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=629 Participants
Patients in Korea 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).
|
|---|---|
|
Number of Patients With Serious Adverse Events
|
33 Participants
|
PRIMARY outcome
Timeframe: Up to 407 days.Population: Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more for up to 24 weeks of follow up.
Number of patients with serious adverse drug reaction in JARDIANCE® treated patients is reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=629 Participants
Patients in Korea 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).
|
|---|---|
|
Number of Patients With Serious Adverse Drug Reaction
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 407 days.Population: Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more for up to 24 weeks of follow up.
Number of patients with drug-related adverse events in JARDIANCE® treated patients is reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=629 Participants
Patients in Korea 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).
|
|---|---|
|
Number of Patients With Drug-related Adverse Events
|
27 Participants
|
PRIMARY outcome
Timeframe: Up to 407 days.Population: Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more for up to 24 weeks of follow up.
Number of patients with non-serious adverse drug reaction in JARDIANCE® treated patients is reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=629 Participants
Patients in Korea 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).
|
|---|---|
|
Number of Patients With Non-serious Adverse Drug Reaction
|
27 Participants
|
PRIMARY outcome
Timeframe: Up to 407 days.Population: Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more for up to 24 weeks of follow up.
Number of patients with adverse event of special interest is reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=629 Participants
Patients in Korea 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).
|
|---|---|
|
Number of Patients With Adverse Event of Special Interest
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 407 days.Population: Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more for up to 24 weeks of follow up.
Number of patients with adverse events leading to discontinuation is reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=629 Participants
Patients in Korea 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).
|
|---|---|
|
Number of Patients With Adverse Events Leading to Discontinuation
|
16 Participants
|
SECONDARY outcome
Timeframe: Data collected at baseline (visit 1), week 12 and week 24.Population: The effectiveness set included those who signed the data release consent form to participate in this study as subject, visited as per the study schedule and took Jardiance® once at least.
Occurrence of hospitalisation for heart failure (first and recurrent) after 12 weeks and 24 weeks of treatment from baseline was reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=519 Participants
Patients in Korea 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).
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|---|---|
|
Occurrence of Hospitalisation for Heart Failure (First and Recurrent) After 12 Weeks and 24 Weeks of Treatment From Baseline
Week 12
|
31 Participants
|
|
Occurrence of Hospitalisation for Heart Failure (First and Recurrent) After 12 Weeks and 24 Weeks of Treatment From Baseline
Week 24
|
33 Participants
|
SECONDARY outcome
Timeframe: Data collected at week 12 and week 24.Population: The effectiveness set included those who signed the data release consent form to participate in this study as subject, visited as per the study schedule and took Jardiance® once at least.
Occurrence of cardiovascular death after 12 weeks and 24 weeks of treatment was reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=519 Participants
Patients in Korea 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).
|
|---|---|
|
Occurrence of Cardiovascular Death After 12 Weeks and 24 Weeks of Treatment
Week 12
|
2 Participants
|
|
Occurrence of Cardiovascular Death After 12 Weeks and 24 Weeks of Treatment
Week 24
|
3 Participants
|
SECONDARY outcome
Timeframe: At baseline and at week 12.Population: The effectiveness set included those who signed the data release consent form to participate in this study as subject, visited as per the study schedule and took Jardiance® once at least. Patients for whom New York Heart Association (NYHA) functional class were not collected at baseline or post-baseline were excluded.
Changes from baseline in New York Heart Association (NYHA) functional class after 12 weeks of treatment was reported. The NYHA Classes of heart failure categorize patients with symptomatic or advanced heart failure based on their physical activity limitations. Class I patients present no limitation of physical activity, and ordinary physical activity does not cause fatigue, palpitations, or shortness of breath. Class II patients present a slight limitation of physical activity, characterized by fatigue, palpitations, shortness of breath, or chest pain as a result of ordinary physical activity. Class III patients are characterized by a marked limitation of physical activity, where less than ordinary activity causes fatigue, palpitations, shortness of breath, or chest pain. Class IV patients present symptoms of heart failure at rest, where any physical activity causes further discomfort. Participants who remain in the same class as at baseline through week 12 will also be presented.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=515 Participants
Patients in Korea 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).
|
|---|---|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
Baseline Class II · Week 12 Class I
|
61 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
Baseline Class II · Week 12 Class II
|
376 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
Baseline Class II · Week 12 Class III
|
11 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
Baseline Class II · Week 12 Class IV
|
1 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
Baseline Class III · Week 12 Class I
|
5 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
Baseline Class III · Week 12 Class II
|
45 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
Baseline Class III · Week 12 Class III
|
9 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
Baseline Class III · Week 12 Class IV
|
0 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
Baseline Class IV · Week 12 Class I
|
1 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
Baseline Class IV · Week 12 Class II
|
5 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
Baseline Class IV · Week 12 Class III
|
1 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
Baseline Class IV · Week 12 Class IV
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and at week 24.Population: The effectiveness set included those who signed the data release consent form to participate in this study as subject, visited as per the study schedule and took Jardiance® once at least. Patients for whom New York Heart Association (NYHA) functional class were not collected at baseline or post-baseline were excluded.
Changes from baseline in New York Heart Association (NYHA) functional class after 24 weeks of treatment was reported. The NYHA Classes of heart failure categorize patients with symptomatic or advanced heart failure based on their physical activity limitations. Class I patients present no limitation of physical activity, and ordinary physical activity does not cause fatigue, palpitations, or shortness of breath. Class II patients present a slight limitation of physical activity, characterized by fatigue, palpitations, shortness of breath, or chest pain as a result of ordinary physical activity. Class III patients are characterized by a marked limitation of physical activity, where less than ordinary activity causes fatigue, palpitations, shortness of breath, or chest pain. Class IV patients present symptoms of heart failure at rest, where any physical activity causes further discomfort. Participants who remain in the same class as at baseline through week 24 will also be presented.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=457 Participants
Patients in Korea 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).
|
|---|---|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
Baseline Class II · Week 24 Class I
|
74 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
Baseline Class II · Week 24 Class II
|
319 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
Baseline Class II · Week 24 Class III
|
8 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
Baseline Class II · Week 24 Class IV
|
0 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
Baseline Class III · Week 24 Class I
|
9 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
Baseline Class III · Week 24 Class II
|
32 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
Baseline Class III · Week 24 Class III
|
9 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
Baseline Class III · Week 24 Class IV
|
0 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
Baseline Class IV · Week 24 Class I
|
1 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
Baseline Class IV · Week 24 Class II
|
5 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
Baseline Class IV · Week 24 Class III
|
0 Participants
|
|
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
Baseline Class IV · Week 24 Class IV
|
0 Participants
|
SECONDARY outcome
Timeframe: Data collected at baseline (visit 1), week 12 and week 24.Population: The effectiveness set included those who signed the data release consent form to participate in this study as subject, visited as per the study schedule and took Jardiance® once at least. Patients for whom Ejection Fraction (EF) results were not collected at baseline or post-baseline were excluded.
Changes in Ejection Fraction (EF) at 12 weeks and 24 weeks compared to baseline was reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=110 Participants
Patients in Korea 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).
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|---|---|
|
Changes in Ejection Fraction (EF) at 12 Weeks and 24 Weeks Compared to Baseline
Week 12 - Baseline
|
8.4 Percentage
Standard Deviation 11.88
|
|
Changes in Ejection Fraction (EF) at 12 Weeks and 24 Weeks Compared to Baseline
Week 24 - Baseline
|
8.1 Percentage
Standard Deviation 12.45
|
SECONDARY outcome
Timeframe: Data collected at baseline (visit 1), week 12 and week 24.Population: The effectiveness set included those who signed the data release consent form to participate in this study as subject, visited as per the study schedule and took Jardiance® once at least. Patients for whom NT-proBNP results were not collected at baseline or post-baseline were excluded.
Changes in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) at 12 weeks and 24 weeks compared to baseline was reported. The results are presented after natural log transformation.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=137 Participants
Patients in Korea 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).
|
|---|---|
|
Changes in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) at 12 Weeks and 24 Weeks Compared to Baseline
Week 12 - Baseline
|
-0.5 ln(pg/mL)
Standard Deviation 1.31
|
|
Changes in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) at 12 Weeks and 24 Weeks Compared to Baseline
Week 24 - Baseline
|
-0.4 ln(pg/mL)
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: Data collected at baseline (visit 1), week 12 and week 24.Population: The effectiveness set included those who signed the data release consent form to participate in this study as subject, visited as per the study schedule and took Jardiance® once at least. Patients for whom HbA1c results were not collected at baseline or post-baseline were excluded.
Changes in Glycosylated Hemoglobin (HbA1c) after 12 weeks and 24 weeks of treatment was reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=90 Participants
Patients in Korea 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).
|
|---|---|
|
Changes in Glycosylated Hemoglobin (HbA1c) After 12 Weeks and 24 Weeks of Treatment
Week 12 - Baseline
|
-0.17 Percentage
Standard Deviation 1.140
|
|
Changes in Glycosylated Hemoglobin (HbA1c) After 12 Weeks and 24 Weeks of Treatment
Week 24 - Baseline
|
-0.24 Percentage
Standard Deviation 0.943
|
SECONDARY outcome
Timeframe: Data collected at baseline (visit 1), week 12 and week 24.Population: The effectiveness set included those who signed the data release consent form to participate in this study as subject, visited as per the study schedule and took Jardiance® once at least. Patients for whom eGFR results were not collected at baseline or post-baseline were excluded.
Change from baseline in Estimated Glomerular Filtration Rate (eGFR) after 12 weeks and 24 weeks of treatment was reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=386 Participants
Patients in Korea 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).
|
|---|---|
|
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 12 Weeks and 24 Weeks of Treatment
Week 12 - Baseline
|
-2.9 milliliters/minute/1.73 square meters
Standard Deviation 11.25
|
|
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 12 Weeks and 24 Weeks of Treatment
Week 14 - Baseline
|
-2.4 milliliters/minute/1.73 square meters
Standard Deviation 11.26
|
SECONDARY outcome
Timeframe: Data collected at baseline (visit 1), week 12 and week 24.Population: The effectiveness set included those who signed the data release consent form to participate in this study as subject, visited as per the study schedule and took Jardiance® once at least. Patients for whom Body weight results were not collected at baseline or post-baseline were excluded.
Change from baseline in Body weight after 12 weeks and 24 weeks of treatment was reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=424 Participants
Patients in Korea 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).
|
|---|---|
|
Change From Baseline in Body Weight After 12 Weeks and 24 Weeks of Treatment
Week 12 - Baseline
|
-0.47 kilogram (kg)
Standard Deviation 3.928
|
|
Change From Baseline in Body Weight After 12 Weeks and 24 Weeks of Treatment
Week 24 - Baseline
|
-0.99 kilogram (kg)
Standard Deviation 4.891
|
SECONDARY outcome
Timeframe: Data collected at baseline (visit 1), week 12 and week 24.Population: The effectiveness set included those who signed the data release consent form to participate in this study as subject, visited as per the study schedule and took Jardiance® once at least. Patients for whom SBP results were not collected at baseline or post-baseline were excluded.
Change from baseline in Systolic Blood Pressure (SBP) after 12 weeks and 24 weeks of treatment was reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=498 Participants
Patients in Korea 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).
|
|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) After 12 Weeks and 24 Weeks of Treatment
Week 12 - Baseline
|
-2.7 Millimeters of mercury (mmHg)
Standard Deviation 16.48
|
|
Change From Baseline in Systolic Blood Pressure (SBP) After 12 Weeks and 24 Weeks of Treatment
Week 24 - Baseline
|
-3.7 Millimeters of mercury (mmHg)
Standard Deviation 17.82
|
SECONDARY outcome
Timeframe: Data collected at baseline (visit 1), week 12 and week 24.Population: The effectiveness set included those who signed the data release consent form to participate in this study as subject, visited as per the study schedule and took Jardiance® once at least. Patients for whom DBP results were not collected at baseline or post-baseline were excluded.
Change from baseline in Diastolic Blood Pressure (DBP) after 12 weeks and 24 weeks of treatment was reported.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=498 Participants
Patients in Korea 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).
|
|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP) After 12 Weeks and 24 Weeks of Treatment
Week 12 - Baseline
|
-2.5 Millimeters of mercury (mmHg)
Standard Deviation 13.78
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) After 12 Weeks and 24 Weeks of Treatment
Week 24 - Baseline
|
-2.7 Millimeters of mercury (mmHg)
Standard Deviation 13.52
|
SECONDARY outcome
Timeframe: Data collected at baseline (visit 1), week 12 and week 24.Population: The effectiveness set included those who signed the data release consent form to participate in this study as subject, visited as per the study schedule and took Jardiance® once at least. Patients for whom effectiveness assessment results were not collected at baseline or post-baseline were excluded.
The result of investigator's overall evaluation at the final visit was reported. The final visit represents each patient's last assessment among Week 12 or Week 24. For the final effectiveness evaluation, the three items (Improved, Unchanged, Worsening) are evaluated by the changes from baseline of the NYHA Class at the end of last visit. 1. Improved: If determined as there is any effect of maintaining or improving disease related factors. 2. Unchanged: If disease related factors have not been changed compared with before administration and not determined as there is any effect of maintaining symptoms. 3. Worsening: If disease related factors are worse than before administration. 'Improved' and 'Unchanged' are assessed as "Effective" and 'Worsening' is assessed as "Ineffective".
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=518 Participants
Patients in Korea 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).
|
|---|---|
|
The Result of Investigator's Overall Evaluation After 12 Weeks and 24 Weeks of Treatment
Improved
|
135 Participants
|
|
The Result of Investigator's Overall Evaluation After 12 Weeks and 24 Weeks of Treatment
Unchanged
|
371 Participants
|
|
The Result of Investigator's Overall Evaluation After 12 Weeks and 24 Weeks of Treatment
Worsening
|
12 Participants
|
Adverse Events
JARDIANCE® Treated Patients
Serious adverse events
| Measure |
JARDIANCE® Treated Patients
n=629 participants at risk
Patients in Korea 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).
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Nervous system disorders
Cerebral infarction
|
0.48%
3/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Nervous system disorders
Dementia
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Psychiatric disorders
Depression
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Infections and infestations
Septic shock
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Infections and infestations
Urinary tract infection
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Cardiac disorders
Angina unstable
|
0.32%
2/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Cardiac disorders
Cardiac failure
|
1.1%
7/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Cardiac disorders
Dilated cardiomyopathy
|
0.48%
3/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Cardiac disorders
Myocarditis
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Cardiac disorders
Pericardial effusion
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Gastrointestinal disorders
Haematochezia
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
General disorders and administration site conditions
Pain
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.16%
1/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
|
Infections and infestations
Pneumonia
|
0.32%
2/629 • Up to 407 days.
Safety set: All patients who signed the data release consent form to participate in this study, took Jardiance® once at least after signing the data release consent form, and were followed up by the physician once or more.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER