Trial Outcomes & Findings for A Study Using Medical Records of Danish People With Type 2 Diabetes Comparing Empagliflozin and Glucagon-Like Peptide-1 Receptor Agonists (GLP1-RA) in the Occurrence of Serious Cardiovascular Outcomes (NCT NCT03993132)
NCT ID: NCT03993132
Last Updated: 2024-02-12
Results Overview
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.
COMPLETED
26774 participants
From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years.
2024-02-12
Participant Flow
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.
All subjects were screened for eligibility to ensure that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14148
|
12626
|
|
Overall Study
COMPLETED
|
14148
|
12626
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Empagliflozin - PS Balanced Cohort
n=14148 Participants
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.
|
Liraglutide - PS Balanced Cohort
n=12626 Participants
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.
|
Total
n=26774 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.55 Years
n=14148 Participants
|
61.19 Years
n=12626 Participants
|
61.37 Years
n=26774 Participants
|
|
Sex: Female, Male
Female
|
5692 Participants
n=14148 Participants
|
5162 Participants
n=12626 Participants
|
10854 Participants
n=26774 Participants
|
|
Sex: Female, Male
Male
|
8456 Participants
n=14148 Participants
|
7464 Participants
n=12626 Participants
|
15920 Participants
n=26774 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Empagliflozin - PS Balanced Cohort
n=14148 Participants
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.
|
Liraglutide - PS Balanced Cohort
n=12626 Participants
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.
|
|---|---|---|
|
Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - OT Analysis
|
36.1 Events per 1000 person-years
|
35.9 Events per 1000 person-years
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Empagliflozin - PS Balanced Cohort
n=14148 Participants
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.
|
Liraglutide - PS Balanced Cohort
n=12626 Participants
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.
|
|---|---|---|
|
Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - ITT Analysis
|
39.9 Events per 1000 person-years
|
37.3 Events per 1000 person-years
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Empagliflozin - PS Balanced Cohort
n=14148 Participants
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.
|
Liraglutide - PS Balanced Cohort
n=12626 Participants
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.
|
|---|---|---|
|
Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - OT Analysis
|
21.1 Events per 1000 person-years
|
22.2 Events per 1000 person-years
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Empagliflozin - PS Balanced Cohort
n=14148 Participants
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.
|
Liraglutide - PS Balanced Cohort
n=12626 Participants
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.
|
|---|---|---|
|
Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - ITT Analysis
|
25.1 Events per 1000 person-years
|
24.3 Events per 1000 person-years
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Empagliflozin - PS Balanced Cohort
n=14148 Participants
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.
|
Liraglutide - PS Balanced Cohort
n=12626 Participants
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.
|
|---|---|---|
|
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
|
18.0 Events per 1000 person-years
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Empagliflozin - PS Balanced Cohort
n=14148 Participants
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.
|
Liraglutide - PS Balanced Cohort
n=12626 Participants
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.
|
|---|---|---|
|
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
|
21.4 Events per 1000 person-years
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Empagliflozin - PS Balanced Cohort
n=14148 Participants
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.
|
Liraglutide - PS Balanced Cohort
n=12626 Participants
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.
|
|---|---|---|
|
Incidence Rate of All-cause Hospitalization or Death - OT Analysis
|
193.5 Events per 1000 patient years
|
212.1 Events per 1000 patient years
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Empagliflozin - PS Balanced Cohort
n=14148 Participants
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.
|
Liraglutide - PS Balanced Cohort
n=12626 Participants
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.
|
|---|---|---|
|
Incidence Rate of All-cause Hospitalization or Death - ITT Analysis
|
175.2 Events per 1000 patient years
|
187.0 Events per 1000 patient years
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Empagliflozin - PS Balanced Cohort
n=14148 Participants
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.
|
Liraglutide - PS Balanced Cohort
n=12626 Participants
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.
|
|---|---|---|
|
Incidence Rate of All Cause Hospitalization - OT Analysis
|
190.2 Events per 1000 patient years
|
208.0 Events per 1000 patient years
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Empagliflozin - PS Balanced Cohort
n=14148 Participants
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.
|
Liraglutide - PS Balanced Cohort
n=12626 Participants
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.
|
|---|---|---|
|
Incidence Rate of All Cause Hospitalization - ITT Analysis
|
171.6 Events per 1000 patient years
|
183.7 Events per 1000 patient years
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Empagliflozin - PS Balanced Cohort
n=14148 Participants
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.
|
Liraglutide - PS Balanced Cohort
n=12626 Participants
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.
|
|---|---|---|
|
Incidence Rate of All-cause Death - OT Analysis
|
12.9 Events per 1000 patient-years
|
13.2 Events per 1000 patient-years
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Empagliflozin - PS Balanced Cohort
n=14148 Participants
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.
|
Liraglutide - PS Balanced Cohort
n=12626 Participants
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.
|
|---|---|---|
|
Incidence Rate of All-cause Death - ITT Analysis
|
18.0 Events per 1000 patient-years
|
17.1 Events per 1000 patient-years
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Empagliflozin - PS Balanced Cohort
n=14148 Participants
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.
|
Liraglutide - PS Balanced Cohort
n=12626 Participants
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.
|
|---|---|---|
|
Incidence Rate of Hospitalization for Heart Failure (HF) - OT Analysis
|
9.3 Events per 1000 patient years
|
10.6 Events per 1000 patient years
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Empagliflozin - PS Balanced Cohort
n=14148 Participants
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.
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Liraglutide - PS Balanced Cohort
n=12626 Participants
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.
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Incidence Rate of Hospitalization for Heart Failure (HF) - ITT Analysis
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9.3 Events per 1000 patient years
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9.4 Events per 1000 patient years
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Adverse Events
Empagliflozin - PS Balanced Cohort
Liraglutide - PS Balanced Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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