Diabetes Mellitus, Type 2
Conditions
Brief summary
The primary research question is to evaluate whether, among patients with type 2 diabetes mellitus (T2D), initiation of empagliflozin changes the adjusted incidence of outcomes compared with initiation of Glucagon-Like Peptide-1 Receptor Agonists (GLP1-RA).
Interventions
DRUGEmpagliflozin
new users (initiators) of Empagliflozin
DRUGLiraglutide
initiators of Liraglutide
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The empagliflozin-exposed population must also meet the following criteria: * Have at least one prescription for empagliflozin or fixed-dose combination of empagliflozin with another drug, with or without treatment with another glucose-lowering drug * Have no prescription/dispensing of SGLT2 inhibitors (including empagliflozin) alone or in fixed-dose combination prior to the index date * Have no prescription/dispensing of a GLP-1 receptor agonist alone or in fixed dose combination prior to the index date The population exposed to GLP1-RA must meet the following criteria: * Have at least one prescription for GLP1-RA or a fixed-dose combination of GLP1-RA with another drug, with or without treatment with another glucose-lowering drug. * Have no prescription/dispensing of a GLP-1 receptor agonist alone or in fixed dose combination prior to the index date * Have no prescription/dispensing of SGLT2 inhibitors (including empagliflozin) alone or in fixed-dose combination prior to the index date
Exclusion criteria
-Patients with type 1 diabetes T1D before the index date will not be included in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Composite outcome includes: All-cause death, acute admission with non-fatal (within 30 days) stroke, with non-fatal (within 30 days) myocardial infarction (MI), admission with unstable angina, coronary revascularization, or acute admission with non-fatal heart failure (HF). The results from on-treatment (OT) analysis are reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class. |
| Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Composite outcome includes: All-cause death, acute admission with non-fatal (within 30 days) stroke, with non-fatal (within 30 days) myocardial infarction (MI), admission with unstable angina, coronary revascularization, or acute admission with non-fatal heart failure (HF). The results from intention-to-treat (ITT) analysis are reported. For the ITT analyses, participants were defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of First Hospitalized Heart Failure (HHF) or Initiation of Community Prescription Drug Therapy With Loop Diuretics - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | The incidence rate of first hospitalized Heart Failure (HHF) or initiation of community prescription drug therapy with loop diuretics based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class. |
| Incidence Rate of First Hospitalized Heart Failure (HHF) or Initiation of Community Prescription Drug Therapy With Loop Diuretics - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | The incidence rate of first hospitalized Heart Failure (HHF) or initiation of community prescription drug therapy with loop diuretics based on intention-to-treat (ITT) analysis was reported. For the ITT analyses, participants are defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date. |
| Incidence Rate of All-cause Hospitalization or Death - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Incidence rate of all-cause hospitalization or death, based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class. |
| Incidence Rate of All-cause Hospitalization or Death - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Incidence rate of all-cause hospitalization or death, based on intent-to-treat (ITT) analysis. For the ITT analyses, participants were defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date. |
| Incidence Rate of All Cause Hospitalization - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Incidence rate of all cause hospitalization, based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class. |
| Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | The incidence rate of heart failure (HF) hospitalization or all-cause death based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class. |
| Incidence Rate of All-cause Death - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Incidence rate of all-cause death, based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class. |
| Incidence Rate of All-cause Death - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Incidence rate of all-cause death, based on intent-to-treat (ITT) analysis. For the ITT analyses, participants were defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date. |
| Incidence Rate of Hospitalization for Heart Failure (HF) - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Incidence rate of hospitalization for heart failure (HF), based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class. |
| Incidence Rate of Hospitalization for Heart Failure (HF) - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Incidence rate of hospitalization for heart failure (HF), based on intent-to-treat (ITT) analysis. For the ITT analyses, participants were defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date. |
| Incidence Rate of All Cause Hospitalization - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Incidence rate of all cause hospitalization, based on intent-to-treat (ITT) analysis. For the ITT analyses, participants were defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date. |
| Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | The incidence rate of heart failure (HF) hospitalization or all-cause death based on Intention-to-treat (ITT) analysis is reported. For the ITT analyses, participants are defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date. |
Countries
Denmark
Participant flow
Recruitment details
This non-interventional cohort study based on existing data planned to compare new users of empagliflozin with new users of Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA) in Denmark between 21015 and 2020. Due to a huge shift after 2018 in drug type use within the GLP-1RA group the final analysis was not completed.
Pre-assignment details
All subjects were screened for eligibility to ensure that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Empagliflozin - PS Balanced Cohort All eligible adult patients (\>18 years) with type 2 diabetes (T2D) initiating treatment with empagliflozin in Denmark between 2015 and 2018, who were included in danish population-based linked registries (Civil Registration System, Danish National Patient Register, National Database of Reimbursed Prescriptions, LABKA Database). Patients were followed-up through 2020. Propensity score (PS) balancing was applied to match new users of empagliflozin to new users of liraglutide. | 14,148 |
| Liraglutide - PS Balanced Cohort All eligible adult patients (\>18 years) with type 2 diabetes (T2D) initiating treatment with liraglutide in Denmark between 2015 to 2018, who were included in danish population-based linked registries (Civil Registration System, Danish National Patient Register, National Database of Reimbursed Prescriptions, LABKA Database). Patients were followed-up through 2020. Propensity score (PS) balancing was applied to match new users of empagliflozin to new users of liraglutide. | 12,626 |
| Total | 26,774 |
Baseline characteristics
| Characteristic | Empagliflozin - PS Balanced Cohort | Liraglutide - PS Balanced Cohort | Total |
|---|---|---|---|
| Age, Continuous | 61.55 Years | 61.19 Years | 61.37 Years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 5692 Participants | 5162 Participants | 10854 Participants |
| Sex: Female, Male Male | 8456 Participants | 7464 Participants | 15920 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 881 / 14,148 | 765 / 12,626 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - ITT Analysis
Composite outcome includes: All-cause death, acute admission with non-fatal (within 30 days) stroke, with non-fatal (within 30 days) myocardial infarction (MI), admission with unstable angina, coronary revascularization, or acute admission with non-fatal heart failure (HF). The results from intention-to-treat (ITT) analysis are reported. For the ITT analyses, participants were defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date.
Time frame: From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
Population: All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin - PS Balanced Cohort | Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - ITT Analysis | 39.9 Events per 1000 person-years |
| Liraglutide - PS Balanced Cohort | Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - ITT Analysis | 37.3 Events per 1000 person-years |
95% CI: [1.01, 1.13]
Primary
Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - OT Analysis
Composite outcome includes: All-cause death, acute admission with non-fatal (within 30 days) stroke, with non-fatal (within 30 days) myocardial infarction (MI), admission with unstable angina, coronary revascularization, or acute admission with non-fatal heart failure (HF). The results from on-treatment (OT) analysis are reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class.
Time frame: From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
Population: All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin - PS Balanced Cohort | Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - OT Analysis | 36.1 Events per 1000 person-years |
| Liraglutide - PS Balanced Cohort | Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - OT Analysis | 35.9 Events per 1000 person-years |
95% CI: [0.91, 1.11]
Secondary
Incidence Rate of All-cause Death - ITT Analysis
Incidence rate of all-cause death, based on intent-to-treat (ITT) analysis. For the ITT analyses, participants were defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date.
Time frame: From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
Population: All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin - PS Balanced Cohort | Incidence Rate of All-cause Death - ITT Analysis | 18.0 Events per 1000 patient-years |
| Liraglutide - PS Balanced Cohort | Incidence Rate of All-cause Death - ITT Analysis | 17.1 Events per 1000 patient-years |
95% CI: [0.97, 1.16]
Secondary
Incidence Rate of All-cause Death - OT Analysis
Incidence rate of all-cause death, based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class.
Time frame: From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
Population: All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin - PS Balanced Cohort | Incidence Rate of All-cause Death - OT Analysis | 12.9 Events per 1000 patient-years |
| Liraglutide - PS Balanced Cohort | Incidence Rate of All-cause Death - OT Analysis | 13.2 Events per 1000 patient-years |
95% CI: [0.83, 1.18]
Secondary
Incidence Rate of All Cause Hospitalization - ITT Analysis
Incidence rate of all cause hospitalization, based on intent-to-treat (ITT) analysis. For the ITT analyses, participants were defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date.
Time frame: From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
Population: All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin - PS Balanced Cohort | Incidence Rate of All Cause Hospitalization - ITT Analysis | 171.6 Events per 1000 patient years |
| Liraglutide - PS Balanced Cohort | Incidence Rate of All Cause Hospitalization - ITT Analysis | 183.7 Events per 1000 patient years |
95% CI: [0.91, 0.96]
Secondary
Incidence Rate of All-cause Hospitalization or Death - ITT Analysis
Incidence rate of all-cause hospitalization or death, based on intent-to-treat (ITT) analysis. For the ITT analyses, participants were defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date.
Time frame: From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
Population: All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin - PS Balanced Cohort | Incidence Rate of All-cause Hospitalization or Death - ITT Analysis | 175.2 Events per 1000 patient years |
| Liraglutide - PS Balanced Cohort | Incidence Rate of All-cause Hospitalization or Death - ITT Analysis | 187.0 Events per 1000 patient years |
95% CI: [0.91, 0.96]
Secondary
Incidence Rate of All-cause Hospitalization or Death - OT Analysis
Incidence rate of all-cause hospitalization or death, based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class.
Time frame: From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
Population: All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin - PS Balanced Cohort | Incidence Rate of All-cause Hospitalization or Death - OT Analysis | 193.5 Events per 1000 patient years |
| Liraglutide - PS Balanced Cohort | Incidence Rate of All-cause Hospitalization or Death - OT Analysis | 212.1 Events per 1000 patient years |
95% CI: [0.88, 0.96]
Secondary
Incidence Rate of All Cause Hospitalization - OT Analysis
Incidence rate of all cause hospitalization, based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class.
Time frame: From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
Population: All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin - PS Balanced Cohort | Incidence Rate of All Cause Hospitalization - OT Analysis | 190.2 Events per 1000 patient years |
| Liraglutide - PS Balanced Cohort | Incidence Rate of All Cause Hospitalization - OT Analysis | 208.0 Events per 1000 patient years |
95% CI: [0.88, 0.96]
Secondary
Incidence Rate of First Hospitalized Heart Failure (HHF) or Initiation of Community Prescription Drug Therapy With Loop Diuretics - ITT Analysis
The incidence rate of first hospitalized Heart Failure (HHF) or initiation of community prescription drug therapy with loop diuretics based on intention-to-treat (ITT) analysis was reported. For the ITT analyses, participants are defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date.
Time frame: From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
Population: All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin - PS Balanced Cohort | Incidence Rate of First Hospitalized Heart Failure (HHF) or Initiation of Community Prescription Drug Therapy With Loop Diuretics - ITT Analysis | 17.7 Events per 1000 person-years |
| Liraglutide - PS Balanced Cohort | Incidence Rate of First Hospitalized Heart Failure (HHF) or Initiation of Community Prescription Drug Therapy With Loop Diuretics - ITT Analysis | 21.4 Events per 1000 person-years |
95% CI: [0.76, 0.91]
Secondary
Incidence Rate of First Hospitalized Heart Failure (HHF) or Initiation of Community Prescription Drug Therapy With Loop Diuretics - OT Analysis
The incidence rate of first hospitalized Heart Failure (HHF) or initiation of community prescription drug therapy with loop diuretics based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class.
Time frame: From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
Population: All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin - PS Balanced Cohort | Incidence Rate of First Hospitalized Heart Failure (HHF) or Initiation of Community Prescription Drug Therapy With Loop Diuretics - OT Analysis | 12.9 Events per 1000 person-years |
| Liraglutide - PS Balanced Cohort | Incidence Rate of First Hospitalized Heart Failure (HHF) or Initiation of Community Prescription Drug Therapy With Loop Diuretics - OT Analysis | 18.0 Events per 1000 person-years |
95% CI: [0.61, 0.83]
Secondary
Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - ITT Analysis
The incidence rate of heart failure (HF) hospitalization or all-cause death based on Intention-to-treat (ITT) analysis is reported. For the ITT analyses, participants are defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date.
Time frame: From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
Population: All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin - PS Balanced Cohort | Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - ITT Analysis | 25.1 Events per 1000 person-years |
| Liraglutide - PS Balanced Cohort | Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - ITT Analysis | 24.3 Events per 1000 person-years |
95% CI: [0.96, 1.11]
Secondary
Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - OT Analysis
The incidence rate of heart failure (HF) hospitalization or all-cause death based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class.
Time frame: From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
Population: All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin - PS Balanced Cohort | Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - OT Analysis | 21.1 Events per 1000 person-years |
| Liraglutide - PS Balanced Cohort | Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - OT Analysis | 22.2 Events per 1000 person-years |
95% CI: [0.84, 1.08]
Secondary
Incidence Rate of Hospitalization for Heart Failure (HF) - ITT Analysis
Incidence rate of hospitalization for heart failure (HF), based on intent-to-treat (ITT) analysis. For the ITT analyses, participants were defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date.
Time frame: From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
Population: All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin - PS Balanced Cohort | Incidence Rate of Hospitalization for Heart Failure (HF) - ITT Analysis | 9.3 Events per 1000 patient years |
| Liraglutide - PS Balanced Cohort | Incidence Rate of Hospitalization for Heart Failure (HF) - ITT Analysis | 9.4 Events per 1000 patient years |
95% CI: [0.88, 1.1]
Secondary
Incidence Rate of Hospitalization for Heart Failure (HF) - OT Analysis
Incidence rate of hospitalization for heart failure (HF), based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class.
Time frame: From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
Population: All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin - PS Balanced Cohort | Incidence Rate of Hospitalization for Heart Failure (HF) - OT Analysis | 9.3 Events per 1000 patient years |
| Liraglutide - PS Balanced Cohort | Incidence Rate of Hospitalization for Heart Failure (HF) - OT Analysis | 10.6 Events per 1000 patient years |
95% CI: [0.72, 1.06]