Trial Outcomes & Findings for Emp-Activity: Empagliflozin Functional Capacity (NCT NCT05350202)
NCT ID: NCT05350202
Last Updated: 2025-08-26
Results Overview
Change from baseline to Week 24 of the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, calculated as \[Week 24\] - \[Baseline\]. The KCCQ includes 23 items across 7 domains: physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, quality of life, and social limitation. This outcome measured the total symptom score (TTS), clinical summary score (CSS), and overall summary score (OSS) in the empagliflozin-treated patients as defined in the clinical study protocol. The TTS evaluates symptom frequency and burden and is calculated as the mean of the symptom frequency score and symptom burden score. The CSS is calculated as the mean of the physical limitation score and total symptom score. The OSS is calculated as the mean of the physical limitation score, total symptom score, quality of life score, and social limitation score. The TTS, CSS, and OSS are represented on a 0-to-100-point scale, where a higher score reflects better health status.
Recruitment status
COMPLETED
Target enrollment
3431 participants
Primary outcome timeframe
At baseline and at week 24.
Results posted on
2025-08-26
Participant Flow
A multinational, non-interventional study based on newly collected data to assess the demographics and treatment patterns of patients with heart failure (HF), with or without diabetes, using a two-cohort design: one cohort included patients with a first prescription of empagliflozin as routine therapy for HF, while the other cohort included patients receiving drugs with a mechanism of action different from empagliflozin.
All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that they (the participants) strictly met all inclusion and none of the exclusion criteria. Participants were not to be allocated to a group if any of the entry criteria were violated.
Participant milestones
| Measure |
Empagliflozin-treated Patients
Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).
|
Non-SGLT2i-treated Patients
Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information.
|
|---|---|---|
|
Visit 1 - Baseline
STARTED
|
3327
|
104
|
|
Visit 1 - Baseline
Full Analysis Set (FAS)
|
3320
|
104
|
|
Visit 1 - Baseline
Treated
|
3309
|
104
|
|
Visit 1 - Baseline
COMPLETED
|
3309
|
104
|
|
Visit 1 - Baseline
NOT COMPLETED
|
18
|
0
|
|
Visit 1 to Visit 2 - 24 Weeks
STARTED
|
3309
|
0
|
|
Visit 1 to Visit 2 - 24 Weeks
COMPLETED
|
3152
|
0
|
|
Visit 1 to Visit 2 - 24 Weeks
NOT COMPLETED
|
157
|
0
|
Reasons for withdrawal
| Measure |
Empagliflozin-treated Patients
Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).
|
Non-SGLT2i-treated Patients
Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information.
|
|---|---|---|
|
Visit 1 - Baseline
Not-treated
|
18
|
0
|
|
Visit 1 to Visit 2 - 24 Weeks
Still active/screening failure
|
25
|
0
|
|
Visit 1 to Visit 2 - 24 Weeks
Other reason than listed
|
36
|
0
|
|
Visit 1 to Visit 2 - 24 Weeks
Death
|
45
|
0
|
|
Visit 1 to Visit 2 - 24 Weeks
Adverse-drug reaction/heart failure hospitalization
|
7
|
0
|
|
Visit 1 to Visit 2 - 24 Weeks
Withdrawal by Subject
|
6
|
0
|
|
Visit 1 to Visit 2 - 24 Weeks
Lost to Follow-up
|
38
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Empagliflozin-treated Patients
n=3320 Participants
Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).
|
Non-SGLT2i-treated Patients
n=104 Participants
Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information.
|
Total
n=3424 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.63 Years
STANDARD_DEVIATION 10.52 • n=3320 Participants
|
79.67 Years
STANDARD_DEVIATION 10.56 • n=104 Participants
|
69.67 Years
STANDARD_DEVIATION 10.52 • n=3424 Participants
|
|
Sex: Female, Male
Female
|
1224 Participants
n=3320 Participants
|
47 Participants
n=104 Participants
|
1271 Participants
n=3424 Participants
|
|
Sex: Female, Male
Male
|
2096 Participants
n=3320 Participants
|
57 Participants
n=104 Participants
|
2153 Participants
n=3424 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
CSS
|
61.64 Units on a scale
STANDARD_DEVIATION 22.45 • n=3314 Participants • Full analysis set: all registered patients who gave informed consent. Patients without baseline KCCQ values were excluded.
|
67.23 Units on a scale
STANDARD_DEVIATION 17.90 • n=103 Participants • Full analysis set: all registered patients who gave informed consent. Patients without baseline KCCQ values were excluded.
|
61.81 Units on a scale
STANDARD_DEVIATION 22.35 • n=3417 Participants • Full analysis set: all registered patients who gave informed consent. Patients without baseline KCCQ values were excluded.
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
TSS
|
59.03 Units on a scale
STANDARD_DEVIATION 24.86 • n=3314 Participants • Full analysis set: all registered patients who gave informed consent. Patients without baseline KCCQ values were excluded.
|
66.13 Units on a scale
STANDARD_DEVIATION 20.57 • n=103 Participants • Full analysis set: all registered patients who gave informed consent. Patients without baseline KCCQ values were excluded.
|
59.25 Units on a scale
STANDARD_DEVIATION 24.76 • n=3417 Participants • Full analysis set: all registered patients who gave informed consent. Patients without baseline KCCQ values were excluded.
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
OSS
|
56.29 Units on a scale
STANDARD_DEVIATION 22.73 • n=3314 Participants • Full analysis set: all registered patients who gave informed consent. Patients without baseline KCCQ values were excluded.
|
61.46 Units on a scale
STANDARD_DEVIATION 20.21 • n=103 Participants • Full analysis set: all registered patients who gave informed consent. Patients without baseline KCCQ values were excluded.
|
56.45 Units on a scale
STANDARD_DEVIATION 22.67 • n=3417 Participants • Full analysis set: all registered patients who gave informed consent. Patients without baseline KCCQ values were excluded.
|
PRIMARY outcome
Timeframe: At baseline and at week 24.Population: Primary endpoint set (PES): All patients, who received at least one dose of empagliflozin for HF and have filled in KCCQ at baseline and week 24.
Change from baseline to Week 24 of the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, calculated as \[Week 24\] - \[Baseline\]. The KCCQ includes 23 items across 7 domains: physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, quality of life, and social limitation. This outcome measured the total symptom score (TTS), clinical summary score (CSS), and overall summary score (OSS) in the empagliflozin-treated patients as defined in the clinical study protocol. The TTS evaluates symptom frequency and burden and is calculated as the mean of the symptom frequency score and symptom burden score. The CSS is calculated as the mean of the physical limitation score and total symptom score. The OSS is calculated as the mean of the physical limitation score, total symptom score, quality of life score, and social limitation score. The TTS, CSS, and OSS are represented on a 0-to-100-point scale, where a higher score reflects better health status.
Outcome measures
| Measure |
Empagliflozin-treated Patients
n=3108 Participants
Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).
|
Non-SGLT2i-treated Patients
Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information.
|
|---|---|---|
|
Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice
CSS
|
14.66 Units on a scale
Standard Deviation 18.44
|
—
|
|
Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice
TSS
|
17.61 Units on a scale
Standard Deviation 21.04
|
—
|
|
Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice
OSS
|
16.47 Units on a scale
Standard Deviation 18.86
|
—
|
SECONDARY outcome
Timeframe: At baseline and at Week 24.Population: Safety set (SAF): All patients of FAS who received empagliflozin at least once.
This outcome measured the number of patients newly treated with empagliflozin who experienced a change in the New York Heart Association (NYHA) Class from baseline to Week 24. 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.
Outcome measures
| Measure |
Empagliflozin-treated Patients
n=3309 Participants
Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).
|
Non-SGLT2i-treated Patients
Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information.
|
|---|---|---|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class II · Week 24 Class I
|
337 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class II · Week 24 Class II
|
1388 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class II · Week 24 Class III
|
54 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class II · Week 24 Class IV
|
0 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class II · Unknown
|
5 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class II · Missing
|
184 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class II · No Week 24 visit
|
13 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class III · Week 24 Class I
|
37 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class III · Week 24 Class II
|
730 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class III · Week 24 Class III
|
368 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class III · Week 24 Class IV
|
3 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class III · Unknown
|
0 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class III · Missing
|
118 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class III · No Week 24 visit
|
7 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class IV · Week 24 Class I
|
0 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class IV · Week 24 Class II
|
20 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class IV · Week 24 Class III
|
22 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class IV · Week 24 Class IV
|
10 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class IV · Unknown
|
0 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class IV · Missing
|
12 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Class IV · No Week 24 visit
|
0 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Missing · Week 24 Class I
|
0 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Missing · Week 24 Class II
|
0 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Missing · Week 24 Class III
|
0 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Missing · Week 24 Class IV
|
0 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Missing · Unknown
|
0 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Missing · Missing
|
1 Participants
|
—
|
|
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Baseline Missing · No Week 24 visit
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At baseline.Population: FAS: All registered patients who gave informed consent.
Number of patients with first prescription of empagliflozin and patients prescribed drugs other than SGLT2 inhibitors with concomitant disease/comorbidities. Concomitant diseases/comorbidities are presented according to the ICD-10-CM (the International Classification of Diseases, Tenth Revision, Clinical Modification) standardized system using the disease code.
Outcome measures
| Measure |
Empagliflozin-treated Patients
n=3320 Participants
Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).
|
Non-SGLT2i-treated Patients
n=104 Participants
Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information.
|
|---|---|---|
|
Number of Participants With Comorbidities
E03.- Other hypothyroidism
|
130 Participants
|
6 Participants
|
|
Number of Participants With Comorbidities
E10.- Insulin-dependent diabetes mellitus
|
103 Participants
|
3 Participants
|
|
Number of Participants With Comorbidities
E11.- Non-insulin-dependent diabetes mellitus
|
626 Participants
|
18 Participants
|
|
Number of Participants With Comorbidities
E66.- Obesity
|
265 Participants
|
6 Participants
|
|
Number of Participants With Comorbidities
E78.- Disorders of lipoprotein metabolism and other lipidaemias
|
1197 Participants
|
49 Participants
|
|
Number of Participants With Comorbidities
E79.- Disorders of purine and pyrimidine metabolism
|
188 Participants
|
3 Participants
|
|
Number of Participants With Comorbidities
I10 Essential (primary) hypertension
|
1380 Participants
|
54 Participants
|
|
Number of Participants With Comorbidities
I11.- Hypertensive heart disease
|
604 Participants
|
21 Participants
|
|
Number of Participants With Comorbidities
I20.- Angina pectoris
|
291 Participants
|
8 Participants
|
|
Number of Participants With Comorbidities
I21.- Acute myocardial infarction
|
186 Participants
|
3 Participants
|
|
Number of Participants With Comorbidities
I25.- Chronic ischaemic heart disease
|
1164 Participants
|
25 Participants
|
|
Number of Participants With Comorbidities
I27.- Other pulmonary heart diseases
|
56 Participants
|
4 Participants
|
|
Number of Participants With Comorbidities
I34.- Nonrheumatic mitral valve disorders
|
517 Participants
|
30 Participants
|
|
Number of Participants With Comorbidities
I35.- Nonrheumatic aortic valve disorders
|
215 Participants
|
18 Participants
|
|
Number of Participants With Comorbidities
I36.- Nonrheumatic tricuspid valve disorders
|
174 Participants
|
11 Participants
|
|
Number of Participants With Comorbidities
I42.- Cardiomyopathy
|
256 Participants
|
8 Participants
|
|
Number of Participants With Comorbidities
I44.- Atrioventricular and left bundle-branch block
|
139 Participants
|
5 Participants
|
|
Number of Participants With Comorbidities
I48 Atrial fibrillation and flutter
|
1183 Participants
|
27 Participants
|
|
Number of Participants With Comorbidities
I49.- Other cardiac arrhythmias
|
132 Participants
|
4 Participants
|
|
Number of Participants With Comorbidities
I70.- Atherosclerosis
|
116 Participants
|
2 Participants
|
|
Number of Participants With Comorbidities
J44.- Other chronic obstructive pulmonary disease
|
117 Participants
|
4 Participants
|
|
Number of Participants With Comorbidities
N18.- Chronic kidney disease
|
211 Participants
|
6 Participants
|
|
Number of Participants With Comorbidities
N40 Hyperplasia of prostate
|
119 Participants
|
1 Participants
|
|
Number of Participants With Comorbidities
Z95.- Presence of cardiac and vascular implants and grafts
|
547 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: At baseline.Population: FAS: All registered patients who gave informed consent.
Number of patients who took concomitant HF-related medication.
Outcome measures
| Measure |
Empagliflozin-treated Patients
n=3320 Participants
Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).
|
Non-SGLT2i-treated Patients
n=104 Participants
Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information.
|
|---|---|---|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Acetylsalicylic acid
|
63 Participants
|
4 Participants
|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Bisoprolol
|
868 Participants
|
19 Participants
|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Candesartan
|
68 Participants
|
4 Participants
|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Carvedilol
|
233 Participants
|
2 Participants
|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Eplerenone
|
517 Participants
|
5 Participants
|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Furosemide
|
913 Participants
|
31 Participants
|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Indapamide
|
58 Participants
|
5 Participants
|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Metoprolol
|
457 Participants
|
11 Participants
|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Nebivolol
|
98 Participants
|
6 Participants
|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Perindopril
|
207 Participants
|
9 Participants
|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Ramipril
|
413 Participants
|
6 Participants
|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Sacubitril
|
112 Participants
|
0 Participants
|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Sacubitril and valsartan
|
443 Participants
|
5 Participants
|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Spironolactone
|
981 Participants
|
20 Participants
|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Torasemide
|
645 Participants
|
5 Participants
|
|
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Valsartan
|
166 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months prior to baseline visit.Population: FAS: All registered patients who gave informed consent.
Number of patients hospitalized at least one time due to heart failure (HF).
Outcome measures
| Measure |
Empagliflozin-treated Patients
n=3320 Participants
Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).
|
Non-SGLT2i-treated Patients
n=104 Participants
Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information.
|
|---|---|---|
|
Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline
|
284 Participants
|
6 Participants
|
Adverse Events
Empagliflozin-treated Patients
Serious events: 74 serious events
Other events: 0 other events
Deaths: 46 deaths
Serious adverse events
| Measure |
Empagliflozin-treated Patients
n=3309 participants at risk
Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg).
|
|---|---|
|
General disorders
Death
|
0.51%
17/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Cardiac disorders
Cardiac failure
|
0.42%
14/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Cardiac disorders
Cardiac arrest
|
0.09%
3/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Cardiac disorders
Cardiogenic shock
|
0.09%
3/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
General disorders
Sudden cardiac death
|
0.09%
3/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.06%
2/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.06%
2/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Cardiac disorders
Atrial fibrillation
|
0.06%
2/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.06%
2/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.06%
2/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Surgical and medical procedures
Hospitalisation
|
0.06%
2/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Cardiac disorders
Myocardial infarction
|
0.06%
2/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
General disorders
Sudden death
|
0.06%
2/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Cardiac disorders
Arrhythmia
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Investigations
Blood pressure increased
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Infections and infestations
Necrotising fasciitis
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Gastrointestinal disorders
Necrotising oesophagitis
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
General disorders
Performance status decreased
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Infections and infestations
Pneumonia
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Nervous system disorders
Polyneuropathy
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Renal and urinary disorders
Renal failure
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.03%
1/3309 • From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
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