Heart Failure
Conditions
Brief summary
This is a multinational non-interventional study based on newly collected data to assess demographics, disease, and treatment pattern of patients with chronic Heart Failure (HF) in a two-cohort design: one cohort will receive first prescription of empagliflozin as routine therapy for HF, the other cohort will receive HF therapy with drugs with another mechanism of action. Treatment of HF according to routine practice is determined by the physician independent of the participation of the patient in this non-interventional study.
Interventions
DRUGEmpagliflozin
Empagliflozin was administered according to the approved product information.
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent prior to study participation * Male and female patients ≥ 18 years at Visit 1 * Patients must be contractually capable and mentally able to understand and follow the instructions of the study personnel * Patients with diagnosis of chronic heart failure NYHA Class 2-4 * Treatment-naïve for SGLT2i at visit 1 * Women of childbearing potential must take appropriate precautions against getting pregnant according to approval of chosen HF drug(s)
Exclusion criteria
* Missing physician's diagnosis of chronic heart failure * Patients hospitalized at visit 1 * Life expectancy ≤ 12 months according to physician's assessment * Lack of informed consent * Pregnant or lactating females * Participation in a parallel interventional clinical trial * Chosen treatment with another SGLT2i drug than empagliflozin * Having been enrolled into the non-empagliflozin-arm of this non-interventional study * Current or prior treatment with SGLT2i at visit 1 * Patients with contraindications according to current Summary of Product Characteristics (SmPC) * Patients with dependency or relationship to the treating physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice | At baseline and at 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | At baseline and at Week 24. | 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. |
| Number of Participants With Comorbidities | At baseline. | 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. |
| Number of Participants With Concomitant Heart-failure (HF) Related Medication | At baseline. | Number of patients who took concomitant HF-related medication. |
| Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline | Up to 6 months prior to baseline visit. | Number of patients hospitalized at least one time due to heart failure (HF). |
Countries
Bulgaria, Czechia, Hungary, Poland, Romania, Switzerland
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 3,320 |
| 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. | 104 |
| Total | 3,424 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Visit 1 - Baseline | Not-treated | 18 | 0 |
| Visit 1 to Visit 2 - 24 Weeks | Adverse-drug reaction/heart failure hospitalization | 7 | 0 |
| Visit 1 to Visit 2 - 24 Weeks | Death | 45 | 0 |
| Visit 1 to Visit 2 - 24 Weeks | Lost to Follow-up | 38 | 0 |
| Visit 1 to Visit 2 - 24 Weeks | Other reason than listed | 36 | 0 |
| Visit 1 to Visit 2 - 24 Weeks | Still active/screening failure | 25 | 0 |
| Visit 1 to Visit 2 - 24 Weeks | Withdrawal by Subject | 6 | 0 |
Baseline characteristics
| Characteristic | Non-SGLT2i-treated Patients | Total | Empagliflozin-treated Patients |
|---|---|---|---|
| Age, Continuous | 79.67 Years STANDARD_DEVIATION 10.56 | 69.67 Years STANDARD_DEVIATION 10.52 | 69.63 Years STANDARD_DEVIATION 10.52 |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) CSS | 67.23 Units on a scale STANDARD_DEVIATION 17.9 | 61.81 Units on a scale STANDARD_DEVIATION 22.35 | 61.64 Units on a scale STANDARD_DEVIATION 22.45 |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) OSS | 61.46 Units on a scale STANDARD_DEVIATION 20.21 | 56.45 Units on a scale STANDARD_DEVIATION 22.67 | 56.29 Units on a scale STANDARD_DEVIATION 22.73 |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) TSS | 66.13 Units on a scale STANDARD_DEVIATION 20.57 | 59.25 Units on a scale STANDARD_DEVIATION 24.76 | 59.03 Units on a scale STANDARD_DEVIATION 24.86 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 47 Participants | 1271 Participants | 1224 Participants |
| Sex: Female, Male Male | 57 Participants | 2153 Participants | 2096 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 46 / 3,309 |
| other Total, other adverse events | 0 / 3,309 |
| serious Total, serious adverse events | 74 / 3,309 |
Outcome results
Primary
Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Empagliflozin-treated Patients | 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 |
| Empagliflozin-treated Patients | 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 |
| Empagliflozin-treated Patients | 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
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
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.
Time frame: At baseline and at Week 24.
Population: Safety set (SAF): All patients of FAS who received empagliflozin at least once.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class IV | Week 24 Class IV | 10 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class IV | Unknown | 0 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class IV | Missing | 12 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class IV | No Week 24 visit | 0 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Missing | Week 24 Class I | 0 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Missing | Week 24 Class II | 0 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Missing | Week 24 Class III | 0 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Missing | Week 24 Class IV | 0 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Missing | Unknown | 0 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Missing | Missing | 1 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Missing | No Week 24 visit | 0 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class II | Week 24 Class I | 337 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class II | Week 24 Class II | 1388 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class II | Week 24 Class III | 54 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class II | Week 24 Class IV | 0 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class II | Unknown | 5 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class II | Missing | 184 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class II | No Week 24 visit | 13 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class III | Week 24 Class I | 37 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class III | Week 24 Class II | 730 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class III | Week 24 Class III | 368 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class III | Week 24 Class IV | 3 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class III | Unknown | 0 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class III | Missing | 118 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class III | No Week 24 visit | 7 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class IV | Week 24 Class I | 0 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class IV | Week 24 Class II | 20 Participants |
| Empagliflozin-treated Patients | Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin | Baseline Class IV | Week 24 Class III | 22 Participants |
Secondary
Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline
Number of patients hospitalized at least one time due to heart failure (HF).
Time frame: Up to 6 months prior to baseline visit.
Population: FAS: All registered patients who gave informed consent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Empagliflozin-treated Patients | Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline | 284 Participants |
| Non-SGLT2i-treated Patients | Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline | 6 Participants |
Secondary
Number of Participants With Comorbidities
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.
Time frame: At baseline.
Population: FAS: All registered patients who gave informed consent.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | I10 Essential (primary) hypertension | 1380 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | E03.- Other hypothyroidism | 130 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | E10.- Insulin-dependent diabetes mellitus | 103 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | E11.- Non-insulin-dependent diabetes mellitus | 626 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | E66.- Obesity | 265 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | E78.- Disorders of lipoprotein metabolism and other lipidaemias | 1197 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | E79.- Disorders of purine and pyrimidine metabolism | 188 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | I11.- Hypertensive heart disease | 604 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | I20.- Angina pectoris | 291 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | I21.- Acute myocardial infarction | 186 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | I25.- Chronic ischaemic heart disease | 1164 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | I27.- Other pulmonary heart diseases | 56 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | I34.- Nonrheumatic mitral valve disorders | 517 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | I35.- Nonrheumatic aortic valve disorders | 215 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | I36.- Nonrheumatic tricuspid valve disorders | 174 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | I42.- Cardiomyopathy | 256 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | I44.- Atrioventricular and left bundle-branch block | 139 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | I48 Atrial fibrillation and flutter | 1183 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | I49.- Other cardiac arrhythmias | 132 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | I70.- Atherosclerosis | 116 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | J44.- Other chronic obstructive pulmonary disease | 117 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | N18.- Chronic kidney disease | 211 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | N40 Hyperplasia of prostate | 119 Participants |
| Empagliflozin-treated Patients | Number of Participants With Comorbidities | Z95.- Presence of cardiac and vascular implants and grafts | 547 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | N40 Hyperplasia of prostate | 1 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | I34.- Nonrheumatic mitral valve disorders | 30 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | E03.- Other hypothyroidism | 6 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | I49.- Other cardiac arrhythmias | 4 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | E10.- Insulin-dependent diabetes mellitus | 3 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | I35.- Nonrheumatic aortic valve disorders | 18 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | N18.- Chronic kidney disease | 6 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | E66.- Obesity | 6 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | I36.- Nonrheumatic tricuspid valve disorders | 11 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | E78.- Disorders of lipoprotein metabolism and other lipidaemias | 49 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | I70.- Atherosclerosis | 2 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | E79.- Disorders of purine and pyrimidine metabolism | 3 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | E11.- Non-insulin-dependent diabetes mellitus | 18 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | I10 Essential (primary) hypertension | 54 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | I42.- Cardiomyopathy | 8 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | I11.- Hypertensive heart disease | 21 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | Z95.- Presence of cardiac and vascular implants and grafts | 15 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | I20.- Angina pectoris | 8 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | I44.- Atrioventricular and left bundle-branch block | 5 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | I21.- Acute myocardial infarction | 3 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | J44.- Other chronic obstructive pulmonary disease | 4 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | I25.- Chronic ischaemic heart disease | 25 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | I48 Atrial fibrillation and flutter | 27 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Comorbidities | I27.- Other pulmonary heart diseases | 4 Participants |
Secondary
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Number of patients who took concomitant HF-related medication.
Time frame: At baseline.
Population: FAS: All registered patients who gave informed consent.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Acetylsalicylic acid | 63 Participants |
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Bisoprolol | 868 Participants |
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Candesartan | 68 Participants |
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Carvedilol | 233 Participants |
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Eplerenone | 517 Participants |
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Furosemide | 913 Participants |
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Indapamide | 58 Participants |
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Metoprolol | 457 Participants |
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Nebivolol | 98 Participants |
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Perindopril | 207 Participants |
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Ramipril | 413 Participants |
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Sacubitril | 112 Participants |
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Sacubitril and valsartan | 443 Participants |
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Spironolactone | 981 Participants |
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Torasemide | 645 Participants |
| Empagliflozin-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Valsartan | 166 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Valsartan | 0 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Acetylsalicylic acid | 4 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Nebivolol | 6 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Bisoprolol | 19 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Sacubitril and valsartan | 5 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Candesartan | 4 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Perindopril | 9 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Carvedilol | 2 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Torasemide | 5 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Eplerenone | 5 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Ramipril | 6 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Furosemide | 31 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Spironolactone | 20 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Indapamide | 5 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Sacubitril | 0 Participants |
| Non-SGLT2i-treated Patients | Number of Participants With Concomitant Heart-failure (HF) Related Medication | Metoprolol | 11 Participants |