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The primary purpose of this research study is to determine the cardiovascular and renal effectiveness and safety of empagliflozin compared to dipeptidyl peptidase-4 inhibitors (DPP4i) in patients with Type 2 Diabetes Mellitus (T2DM) with and without established kidney disease.
The secondary purpose of this research study is to determine the cardiovascular and renal effectiveness and safety of any Sodium glucose co-transporter-2 inhibitors (SGLT2i) compared to Glucagon-like Peptide-1 Receptor Agonists (GLP1RA) in patients with T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin initiators | Patient with type 2 diabetes, with or without Chronic Kidney Disease (CKD), who initiated Empagliflozin between January 1, 2016 and December 31, 2020. |
| |
| Dipeptidyl peptidate-4 inhibitor (DPP4i) initiators | Patient with type 2 diabetes, with or without Chronic Kidney Disease (CKD), who initiated dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | Empagliflozin |
| |
| Dipeptidyl Peptidate-4 inhibitors |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of the Composite Outcome Including 40% Decline in Estimated Glomerular Filtration Rate (eGFR), Incident End-stage Renal Disease (ESRD) and All-cause Death | 40% decline in eGFR: at least 2 measurements during follow-up of at least a 40% decline relative to baseline separated by >= 28 days. the second eGFR measurement is required to be within 2 years from index, at which time, all patients were censored. ESKD: at least 1 kidney transplant or ESKD diagnosis/procedure or at least 2 dialysis diagnoses/procedures separated by >= 28 days or eGFR<15 on 2 measurements separated by >= 28 days. Post-LASSO overlap weighting was used. A LASSO penalized regression model was created with covariates of interest, subgroup variables, and all pairwise interactions. Variables chosen by the LASSO model were refit to a logistic model in order to calculate the PS estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and for the CKD and non-CKD cohorts. | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of the 40% Decline in Estimated Glomerular Filtration Rate (eGFR) | 40% decline in eGFR: at least 2 measurements (second measurement must be within 2 years) during follow-up of at least a 40% decline relative to baseline separated by >= 28 days. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. |
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Inclusion criteria:
Patients ≥18 years old
Having a diagnosis of type 2 diabetes in 12 months before the index date (defined as the date of initiation of empagliflozin or Glucagon-like Peptide-1 Receptor Agonists (GLP1RA) or Dipeptidyl Peptidate-4 inhibitor (DPP4i), based on the cohort evaluated), based on International Classification of Diseases (ICD)-9 and -10 codes and other available data
Record of prescription for empagliflozin, any Sodium glucose co-transporter-2 inhibitors (SGLT2i), any DPP4 inhibitor, or any GLP1RA use between 1 January 2015 and 31 December 2020, and
No record of any prescription for the drugs being compared during the 12 months + 30-day grace preceding the index date period, i.e.,
Exclusion criteria:
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The analysis will include adults (≥18 years) with type 2 diabetes with or without kidney disease in the US.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Clinical Research Institute | Durham | North Carolina | 27707 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39142723 | Derived | Edmonston D, Mulder H, Lydon E, Chiswell K, Lampron Z, Shay C, Marsolo K, Shah RC, Jones WS, Gordon H, Hwang W, Ayoub I, Ford D, Chamberlain A, Rao A, Fonseca V, Chang A, Ahmad F, Hung A, Hunt K, Butler J, Bosworth HB, Pagidipati N. Kidney and Cardiovascular Effectiveness of SGLT2 Inhibitors vs GLP-1 Receptor Agonists in Type 2 Diabetes. J Am Coll Cardiol. 2024 Aug 20;84(8):696-708. doi: 10.1016/j.jacc.2024.06.016. |
| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study.
This was a non-interventional, retrospective cohort study (NIS) using existing data from 20 US health systems, the study period was from 1 Jan 2014 through 31 December 2021, to determine the cardiovascular and renal effectiveness and safety up to 24 months after initiation of empagliflozin compared to dipeptidyl peptidate-4 inhibitor (DPP4i) in patients with type 2 diabetes.
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| ID | Title | Description |
|---|---|---|
| FG000 | Empagliflozin Initiators | Patient with type 2 diabetes, with or without Chronic Kidney Disease (CKD), who initiated Empagliflozin between January 1, 2016 and December 31, 2020. |
| FG001 | Dipeptidyl Peptidate-4 Inhibitor (DPP4i) Initiators | Patient with type 2 diabetes, with or without Chronic Kidney Disease (CKD), who initiated dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model.
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| ID | Title | Description |
|---|---|---|
| BG000 | Empagliflozin Initiators | Patient with type 2 diabetes, with or without Chronic Kidney Disease (CKD), who initiated Empagliflozin between January 1, 2016 and December 31, 2020. |
| BG001 | Dipeptidyl Peptidate-4 Inhibitor (DPP4i) Initiators |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence Rate of the Composite Outcome Including 40% Decline in Estimated Glomerular Filtration Rate (eGFR), Incident End-stage Renal Disease (ESRD) and All-cause Death | 40% decline in eGFR: at least 2 measurements during follow-up of at least a 40% decline relative to baseline separated by >= 28 days. the second eGFR measurement is required to be within 2 years from index, at which time, all patients were censored. ESKD: at least 1 kidney transplant or ESKD diagnosis/procedure or at least 2 dialysis diagnoses/procedures separated by >= 28 days or eGFR<15 on 2 measurements separated by >= 28 days. Post-LASSO overlap weighting was used. A LASSO penalized regression model was created with covariates of interest, subgroup variables, and all pairwise interactions. Variables chosen by the LASSO model were refit to a logistic model in order to calculate the PS estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years |
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
No adverse events (AEs) were collected on an individual case level. Serious AEs and Other AEs are not collected in the database. All-Cause Mortality is an outcome of this study and thus additionally reported below.
Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 US health systems that have mapped their EHR data to the National PCORnet Common Data Model.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Empagliflozin Initiators | Patient with type 2 diabetes, with or without Chronic Kidney Disease (CKD), who initiated Empagliflozin between January 1, 2016 and December 31, 2020. |
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Limitations inherent to all electronic health record (EHR) based studies, including potential for missing data (i.e., data that was generated through a different health system) or inaccurate data based on billing codes. This limitation could have resulted in HCRU not captured in the current study which could have attenuated the observed results (e.g., medications, hospitalizations, etc).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim , Call Center | Boehringer Ingelheim | 1-800-243-0127 | 001 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 26, 2023 | Apr 23, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 28, 2023 | Apr 23, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| Drug |
Dipeptidyl Peptidate-4 inhibitors |
|
| Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
| Incidence Rate of End-stage Kidney Disease (ESKD) | ESKD definition: at least 1 kidney transplant or ESKD diagnosis/procedure or at least 2 dialysis diagnoses/procedures separated by >= 28 days or eGFR<15 on 2 measurements separated by >= 28 days. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
| Incidence Rate of Dialysis | Incident dialysis, given dialysis in the 12 months preceding index date is a disqualifying diagnosis/procedure. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
| Incidence Rate of Kidney Transplant | Kidney transplant: any procedure associated with healthcare encounters, including hospitalizations and specialist outpatient and primary care encounters. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
| Incidence Rate of Composite Outcome Including Acute Hospitalization for Heart Failure and All-cause Death | Composite outcome including acute hospitalization for heart failure and All-cause death: Any diagnosis of heart failure associated with hospital admission, including inpatient and emergency department (ED) to inpatient encounters. From death records provided by sites, supplemented with linkage using Datavant Software. Post-LASSO overlap weighting was used. A LASSO penalized regression model was created with covariates of interest, subgroup variables, and all pairwise interactions. Variables chosen by the LASSO model were refit to a logistic model in order to calculate the PS estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
| Incidence Rate of Acute Hospitalization for Heart Failure | Acute hospitalization for heart failure: Any diagnosis of heart failure associated with hospital admission, including inpatient and emergency department (ED) to inpatient encounters. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
| Incidence Rate of All-cause Death | All-cause death, from death records provided by sites, supplemented with linkage using Datavant Software. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. a LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
| Incidence Rate of the Composite Outcome Including MI, Stroke, All-cause Death and Coronary Revascularization Procedure | Composite outcome including MI, Stroke, All-cause death and Coronary revascularization procedure: For MI and stroke, any inpatient diagnosis associated with healthcare encounters, including inpatient and ED to inpatient For all-cause death, death records provided by sites, supplemented with linkage using Datavant Software. Post-LASSO overlap weighting was used. A LASSO penalized regression model was created with covariates of interest, subgroup variables, and all pairwise interactions. Variables chosen by the LASSO model were refit to a logistic model in order to calculate the PS estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
| Incidence Rate of the Composite Outcome Including MI, Stroke, All-cause Death (MACE) | Composite outcome including MI, Stroke, All-cause death: For MI and stroke, any inpatient diagnosis associated with healthcare encounters, including inpatient and ED to inpatient For all-cause death, death records provided by sites, supplemented with linkage using Datavant Software. Post-LASSO overlap weighting was used. A LASSO penalized regression model was created with covariates of interest, subgroup variables, and all pairwise interactions. Variables chosen by the LASSO model were refit to a logistic model in order to calculate the PS estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
| Incidence Rate of Diabetic Ketoacidosis | Any diabetic ketoacidosis diagnosis associated with healthcare encounters in the inpatient setting. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
| Incidence Rate of Severe Hypoglycemia | Any severe hypoglycemia diagnosis associated with healthcare encounters in the inpatient or ED setting. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
| Incidence Rate of Urinary Tract Cancer | Two or more urinary tract cancer diagnoses associated with healthcare encounters within 2 months. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
| Incidence Rate of Severe Urinary Tract Infections (UTI) | Any severe Urinary Tract Infections (UTI) diagnosis associated with healthcare encounters in the inpatient or ED setting for Pyelonephritis or Urosepsis. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
| Incidence Rate of Acute Kidney Injury (AKI) That Requires Dialysis | Any Acute kidney injury diagnosis associated with inpatient healthcare encounters for AKI plus at least one inpatient encounter indicating dialysis within 28 days of the AKI encounter. Two or more dialysis encounters separated by 28 days or more was excluded from this definition. Post-LASSO overlap weighting was used. A LASSO penalized regression model was created with covariates of interest, subgroup variables, and all pairwise interactions. Variables chosen by the LASSO model were refit to a logistic model in order to calculate the PS estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
| Incidence Rate of Genital Mycotic Infection | Any genital mycotic infection diagnosis associated with healthcare encounters, including hospitalizations and outpatient encounters, or prescription for fluconazole. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
Patient with type 2 diabetes, with or without Chronic Kidney Disease (CKD), who initiated dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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| Secondary | Incidence Rate of the 40% Decline in Estimated Glomerular Filtration Rate (eGFR) | 40% decline in eGFR: at least 2 measurements (second measurement must be within 2 years) during follow-up of at least a 40% decline relative to baseline separated by >= 28 days. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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| Secondary | Incidence Rate of End-stage Kidney Disease (ESKD) | ESKD definition: at least 1 kidney transplant or ESKD diagnosis/procedure or at least 2 dialysis diagnoses/procedures separated by >= 28 days or eGFR<15 on 2 measurements separated by >= 28 days. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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| Secondary | Incidence Rate of Dialysis | Incident dialysis, given dialysis in the 12 months preceding index date is a disqualifying diagnosis/procedure. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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| Secondary | Incidence Rate of Kidney Transplant | Kidney transplant: any procedure associated with healthcare encounters, including hospitalizations and specialist outpatient and primary care encounters. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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| Secondary | Incidence Rate of Composite Outcome Including Acute Hospitalization for Heart Failure and All-cause Death | Composite outcome including acute hospitalization for heart failure and All-cause death: Any diagnosis of heart failure associated with hospital admission, including inpatient and emergency department (ED) to inpatient encounters. From death records provided by sites, supplemented with linkage using Datavant Software. Post-LASSO overlap weighting was used. A LASSO penalized regression model was created with covariates of interest, subgroup variables, and all pairwise interactions. Variables chosen by the LASSO model were refit to a logistic model in order to calculate the PS estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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| Secondary | Incidence Rate of Acute Hospitalization for Heart Failure | Acute hospitalization for heart failure: Any diagnosis of heart failure associated with hospital admission, including inpatient and emergency department (ED) to inpatient encounters. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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| Secondary | Incidence Rate of All-cause Death | All-cause death, from death records provided by sites, supplemented with linkage using Datavant Software. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. a LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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| Secondary | Incidence Rate of the Composite Outcome Including MI, Stroke, All-cause Death and Coronary Revascularization Procedure | Composite outcome including MI, Stroke, All-cause death and Coronary revascularization procedure: For MI and stroke, any inpatient diagnosis associated with healthcare encounters, including inpatient and ED to inpatient For all-cause death, death records provided by sites, supplemented with linkage using Datavant Software. Post-LASSO overlap weighting was used. A LASSO penalized regression model was created with covariates of interest, subgroup variables, and all pairwise interactions. Variables chosen by the LASSO model were refit to a logistic model in order to calculate the PS estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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|
| Secondary | Incidence Rate of the Composite Outcome Including MI, Stroke, All-cause Death (MACE) | Composite outcome including MI, Stroke, All-cause death: For MI and stroke, any inpatient diagnosis associated with healthcare encounters, including inpatient and ED to inpatient For all-cause death, death records provided by sites, supplemented with linkage using Datavant Software. Post-LASSO overlap weighting was used. A LASSO penalized regression model was created with covariates of interest, subgroup variables, and all pairwise interactions. Variables chosen by the LASSO model were refit to a logistic model in order to calculate the PS estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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| Secondary | Incidence Rate of Diabetic Ketoacidosis | Any diabetic ketoacidosis diagnosis associated with healthcare encounters in the inpatient setting. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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| Secondary | Incidence Rate of Severe Hypoglycemia | Any severe hypoglycemia diagnosis associated with healthcare encounters in the inpatient or ED setting. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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| Secondary | Incidence Rate of Urinary Tract Cancer | Two or more urinary tract cancer diagnoses associated with healthcare encounters within 2 months. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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| Secondary | Incidence Rate of Severe Urinary Tract Infections (UTI) | Any severe Urinary Tract Infections (UTI) diagnosis associated with healthcare encounters in the inpatient or ED setting for Pyelonephritis or Urosepsis. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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| Secondary | Incidence Rate of Acute Kidney Injury (AKI) That Requires Dialysis | Any Acute kidney injury diagnosis associated with inpatient healthcare encounters for AKI plus at least one inpatient encounter indicating dialysis within 28 days of the AKI encounter. Two or more dialysis encounters separated by 28 days or more was excluded from this definition. Post-LASSO overlap weighting was used. A LASSO penalized regression model was created with covariates of interest, subgroup variables, and all pairwise interactions. Variables chosen by the LASSO model were refit to a logistic model in order to calculate the PS estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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| Secondary | Incidence Rate of Genital Mycotic Infection | Any genital mycotic infection diagnosis associated with healthcare encounters, including hospitalizations and outpatient encounters, or prescription for fluconazole. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts. | Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model. | Posted | Number | (First) events per 1000 patient years | Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. |
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|
| 341 |
| 20,279 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Dipeptidyl Peptidate-4 Inhibitor (DPP4i) Initiators | Patient with type 2 diabetes, with or without Chronic Kidney Disease (CKD), who initiated dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. | 1,528 | 41,918 | 0 | 0 | 0 | 0 |
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.
| D004700 | Endocrine System Diseases |
|
Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. |
| Regression, Cox |
| 0.02 |
| Hazard Ratio (HR) |
| 0.61 |
| 2-Sided |
| 95 |
| 0.41 |
| 0.91 |
Ratio calculated as Empagliflozin/DPP4i |
| Other |
| Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. | Regression, Cox | 0.08 | Hazard Ratio (HR) | 0.80 | 2-Sided | 95 | 0.63 | 1.03 | Ratio calculated as Empagliflozin/DPP4i | Other |
|
Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. |
| Regression, Cox |
| 0.09 |
| Hazard Ratio (HR) |
| 0.61 |
| 2-Sided |
| 95 |
| 0.35 |
| 1.09 |
Ratio calculated as Empagliflozin/DPP4i |
| Other |
| Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. | Regression, Cox | 0.30 | Hazard Ratio (HR) | 0.75 | 2-Sided | 95 | 0.43 | 1.29 | Ratio calculated as Empagliflozin/DPP4i | Other |
|
Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. |
| Regression, Cox |
| 0.12 |
| Hazard Ratio (HR) |
| 0.63 |
| 2-Sided |
| 95 |
| 0.35 |
| 1.12 |
Ratio calculated as Empagliflozin/DPP4i |
| Other |
| Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. | Regression, Cox | 0.52 | Hazard Ratio (HR) | 0.84 | 2-Sided | 95 | 0.50 | 1.42 | Ratio calculated as Empagliflozin/DPP4i | Other |
|
Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. |
| Regression, Cox |
| 0.12 |
| Hazard Ratio (HR) |
| 0.82 |
| 2-Sided |
| 95 |
| 0.65 |
| 1.05 |
Ratio calculated as Empagliflozin/DPP4i |
| Other |
| Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. | Regression, Cox | 0.10 | Hazard Ratio (HR) | 0.85 | 2-Sided | 95 | 0.70 | 1.03 | Ratio calculated as Empagliflozin/DPP4i | Other |
|
Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. |
| Regression, Cox |
| 0.50 |
| Hazard Ratio (HR) |
| 0.90 |
| 2-Sided |
| 95 |
| 0.65 |
| 1.24 |
Ratio calculated as Empagliflozin/DPP4i |
| Other |
| Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. | Regression, Cox | 0.50 | Hazard Ratio (HR) | 0.91 | 2-Sided | 95 | 0.68 | 1.20 | Ratio calculated as Empagliflozin/DPP4i | Other |
|
Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. |
| Regression, Cox |
| 0.03 |
| Hazard Ratio (HR) |
| 0.69 |
| 2-Sided |
| 95 |
| 0.49 |
| 0.96 |
Ratio calculated as Empagliflozin/DPP4i |
| Other |
| Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. | Regression, Cox | 0.074 | Hazard Ratio (HR) | 0.80 | 2-Sided | 95 | 0.63 | 1.02 | Ratio calculated as Empagliflozin/DPP4i | Other |
|
Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. |
| Regression, Cox |
| 0.63 |
| Hazard Ratio (HR) |
| 1.04 |
| 2-Sided |
| 95 |
| 0.90 |
| 1.20 |
Ratio calculated as Empagliflozin/DPP4i |
| Other |
| Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. | Regression, Cox | 0.52 | Hazard Ratio (HR) | 1.03 | 2-Sided | 95 | 0.94 | 1.14 | Ratio calculated as Empagliflozin/DPP4i | Other |
|
Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. |
| Regression, Cox |
| 0.03 |
| Hazard Ratio (HR) |
| 0.74 |
| 2-Sided |
| 95 |
| 0.57 |
| 0.97 |
Ratio calculated as Empagliflozin/DPP4i |
| Other |
| Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. | Regression, Cox | 0.10 | Hazard Ratio (HR) | 0.85 | 2-Sided | 95 | 0.71 | 1.03 | Ratio calculated as Empagliflozin/DPP4i | Other |
|
Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. |
| Regression, Cox |
| 0.93 |
| Hazard Ratio (HR) |
| 1.05 |
| 2-Sided |
| 95 |
| 0.40 |
| 2.72 |
Ratio calculated as Empagliflozin/DPP4i |
| Other |
| Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. | Regression, Cox | 0.113 | Hazard Ratio (HR) | 1.47 | 2-Sided | 95 | 0.91 | 2.38 | Ratio calculated as Empagliflozin/DPP4i | Other |
|
Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. |
| Regression, Cox |
| 0.32 |
| Hazard Ratio (HR) |
| 0.80 |
| 2-Sided |
| 95 |
| 0.51 |
| 1.24 |
Ratio calculated as Empagliflozin/DPP4i |
| Other |
| Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. | Regression, Cox | 0.81 | Hazard Ratio (HR) | 0.96 | 2-Sided | 95 | 0.71 | 1.30 | Ratio calculated as Empagliflozin/DPP4i | Other |
|
Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. |
| Regression, Cox |
| 0.82 |
| Hazard Ratio (HR) |
| 0.93 |
| 2-Sided |
| 95 |
| 0.51 |
| 1.70 |
Ratio calculated as Empagliflozin/DPP4i |
| Other |
| Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. | Regression, Cox | 0.76 | Hazard Ratio (HR) | 0.93 | 2-Sided | 95 | 0.60 | 1.45 | Ratio calculated as Empagliflozin/DPP4i | Other |
|
Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. |
| Regression, Cox |
| 0.34 |
| Hazard Ratio (HR) |
| 0.46 |
| 2-Sided |
| 95 |
| 0.09 |
| 2.27 |
Ratio calculated as Empagliflozin/DPP4i |
| Other |
| Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. | Regression, Cox | 0.72 | Hazard Ratio (HR) | 0.82 | 2-Sided | 95 | 0.29 | 2.33 | Ratio calculated as Empagliflozin/DPP4i | Other |
|
Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. |
| Regression, Cox |
| 0.31 |
| Hazard Ratio (HR) |
| 0.59 |
| 2-Sided |
| 95 |
| 0.21 |
| 1.64 |
Ratio calculated as Empagliflozin/DPP4i |
| Other |
| Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. | Regression, Cox | 0.76 | Hazard Ratio (HR) | 1.16 | 2-Sided | 95 | 0.46 | 2.92 | Ratio calculated as Empagliflozin/DPP4i | Other |
|
Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. |
| Regression, Cox |
| <0.001 |
| Hazard Ratio (HR) |
| 1.84 |
| 2-Sided |
| 95 |
| 1.48 |
| 2.30 |
Ratio calculated as Empagliflozin/DPP4i |
| Other |
| Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment. | Regression, Cox | <0.001 | Hazard Ratio (HR) | 1.70 | 2-Sided | 95 | 1.54 | 1.87 | Ratio calculated as Empagliflozin/DPP4i | Other |