Diabetes Mellitus, Type 2
Conditions
Brief summary
Empagliflozin vs. Dipeptidyl Peptidase 4 (DPP-4) Inhibitors and Glucagon-like Peptide-1 Receptor Agonists (GLP-1-RA) Cost of Care Study: a German claims data analysis
Interventions
DRUGEmpagliflozin
film coated tablet
DRUGDPP-4i
film coated tablets, specifically Sitagliptin
DRUGGLP-1-RA
subcutaneous injection or tablet
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Continuous insurance by the sickness fund for the entire period (01/01/2014 - 31/12/2018; death of a patient is the only accepted exception from this rule) * At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11.-) in the period 01/01/2014 to 31/12/2016, but before or on index date (i.e. first Empagliflozin or DPP-4i /Sitagliptin prescription). * At least one prescription of Empagliflozin or a DPP-4i /Sitagliptin in the inclusion period (01/01/2015 - 31/12/2016)
Exclusion criteria
* At least one prescription of a sodium glucose transporter 2 inhibitor (SGLT-2i), DPP-4i or GLP-1-RA in the baseline period (01/01/2014 - 31/12/2014) * During follow-up, patients will be censored if they switch to any SGLT-2i, DPP-4i or GLP-1-RA or initiate a concomitant use of any SGLT-2i, DPP-4i or GLP-1-RA (free or fixed-dose combinations).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Direct Healthcare Cost | Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period. | The direct healthcare cost is reported, including inpatient cost, outpatient cost, medication cost, and total cost. Patients starting Empagliflozin (EMPA) versus either Dipeptidyl peptidase 4 inhibitor (DPP-4i), Sitagliptin (SITA) or Glucagon-like peptide-1 receptor agonist (GLP-1-RA) were matched 1:1 based on a propensity score using a nearest-neighbor matching algorithm without replacement and a maximum caliper of 0.001. The propensity scores were derived by logistic regression models estimating the probability of a patient belonging to the different treatment groups (three estimations: EMPA versus DPP-4i, EMPA versus SITA, and EMPA versus GLP-1-RA). The cost per observed patient year is calculated as the sum of the cost/ sum of the observed time \[year\] over all patients. Final values were rounded to the nearest digit. |
| Healthcare Resource Utilization | Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period. | Healthcare resource utilization includes hospitalizations, hospital stays. outpatient visits, and rehabilitation stays. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Indirect Healthcare Costs (Including Indirect Costs of Days Absent From Work) | Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period. | Indirect healthcare costs (including indirect costs of days absent from work) includes indirect costs for hospitalization, outpatient visits, absent from work, and rehabilitation stays. |
Countries
Germany
Participant flow
Recruitment details
This retrospective study was to compare healthcare cost associated with different antidiabetic drug treatments among the incident users of Empagliflozin (EMPA), any Dipeptidyl peptidase 4 inhibitor (DPP-4i) (specifically Sitagliptin) or any Glucagon-like peptide-1 receptor agonist (GLP-1-RA), based on data covering 2015 - 2018 from Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset.
Pre-assignment details
All subjects who strictly met all inclusion and none of the exclusion criteria were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| All Patients Who Started an Empagliflozin Therapy All participants who met the inclusion criteria and none of the exclusion criteria of this study, who had at least two outpatient diagnoses and/or one inpatient diagnosis of Type 2 diabetes mellitus (T2DM) and received at least one outpatient prescription with Empagliflozin (EMPA) between 2015 - 2018 from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset. | 3,285 |
| All Patients Who Started a DPP-4 Inhibitor (Specifically Sitagliptin) Therapy All participants who met the inclusion criteria and none of the exclusion criteria of this study, who had at least two outpatient diagnoses and/or one inpatient diagnosis of Type 2 diabetes mellitus (T2DM) and received at least one outpatient prescription with Dipeptidyl peptidase 4 (DPP-4) inhibitor (DPP-4i) (specifically Sitagliptin) between 2015 - 2018 from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset. | 19,433 |
| All Patients Who Started a GLP-1 Receptor Agonist Therapy All participants who met the inclusion criteria and none of the exclusion criteria of this study, who had at least two outpatient diagnoses and/or one inpatient diagnosis of Type 2 diabetes mellitus (T2DM) and received at least one outpatient prescription with Glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1-RA) between 2015 - 2018 from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset. | 1,747 |
| Total | 24,465 |
Baseline characteristics
| Characteristic | All Patients Who Started an Empagliflozin Therapy | All Patients Who Started a DPP-4 Inhibitor (Specifically Sitagliptin) Therapy | All Patients Who Started a GLP-1 Receptor Agonist Therapy | Total |
|---|---|---|---|---|
| Age, Continuous | 60.0 Years STANDARD_DEVIATION 11 | 63.3 Years STANDARD_DEVIATION 12.6 | 55.0 Years STANDARD_DEVIATION 12 | 62.3 Years STANDARD_DEVIATION 13.4 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 1110 Participants | 7705 Participants | 754 Participants | 9569 Participants |
| Sex: Female, Male Male | 2175 Participants | 11728 Participants | 993 Participants | 14896 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Direct Healthcare Cost
The direct healthcare cost is reported, including inpatient cost, outpatient cost, medication cost, and total cost. Patients starting Empagliflozin (EMPA) versus either Dipeptidyl peptidase 4 inhibitor (DPP-4i), Sitagliptin (SITA) or Glucagon-like peptide-1 receptor agonist (GLP-1-RA) were matched 1:1 based on a propensity score using a nearest-neighbor matching algorithm without replacement and a maximum caliper of 0.001. The propensity scores were derived by logistic regression models estimating the probability of a patient belonging to the different treatment groups (three estimations: EMPA versus DPP-4i, EMPA versus SITA, and EMPA versus GLP-1-RA). The cost per observed patient year is calculated as the sum of the cost/ sum of the observed time \[year\] over all patients. Final values were rounded to the nearest digit.
Time frame: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.
Population: All eligible participants in this study, with non-missing outcome measures, and matched via propensity score adjusting for potential differences in patient characteristics and prior disease and treatment history among cohorts. The Dipeptidyl peptidase 4 inhibitor (DPP-4i) group and the Sitagliptin group are not mutually exclusive.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i)) | Direct Healthcare Cost | Total | 4247 Euro / patient-year |
| Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i)) | Direct Healthcare Cost | Medication | 1966 Euro / patient-year |
| Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i)) | Direct Healthcare Cost | Inpatient | 1455 Euro / patient-year |
| Empagliflozin (Matched to Dipeptidyl Peptidase 4 Inhibitor (DPP-4i)) | Direct Healthcare Cost | Outpatient | 853 Euro / patient-year |
| Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched) | Direct Healthcare Cost | Inpatient | 3040 Euro / patient-year |
| Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched) | Direct Healthcare Cost | Outpatient | 1280 Euro / patient-year |
| Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched) | Direct Healthcare Cost | Total | 7009 Euro / patient-year |
| Dipeptidyl Peptidase 4 Inhibitor (DPP-4i) (Matched) | Direct Healthcare Cost | Medication | 2689 Euro / patient-year |
| Empagliflozin (Matched to Sitagliptin (SITA)) | Direct Healthcare Cost | Total | 4319 Euro / patient-year |
| Empagliflozin (Matched to Sitagliptin (SITA)) | Direct Healthcare Cost | Inpatient | 1486 Euro / patient-year |
| Empagliflozin (Matched to Sitagliptin (SITA)) | Direct Healthcare Cost | Outpatient | 863 Euro / patient-year |
| Empagliflozin (Matched to Sitagliptin (SITA)) | Direct Healthcare Cost | Medication | 1970 Euro / patient-year |
| Sitagliptin (SITA) (Matched) | Direct Healthcare Cost | Medication | 2516 Euro / patient-year |
| Sitagliptin (SITA) (Matched) | Direct Healthcare Cost | Total | 6535 Euro / patient-year |
| Sitagliptin (SITA) (Matched) | Direct Healthcare Cost | Inpatient | 2806 Euro / patient-year |
| Sitagliptin (SITA) (Matched) | Direct Healthcare Cost | Outpatient | 1213 Euro / patient-year |
| Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA)) | Direct Healthcare Cost | Total | 4895 Euro / patient-year |
| Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA)) | Direct Healthcare Cost | Medication | 2433 Euro / patient-year |
| Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA)) | Direct Healthcare Cost | Outpatient | 917 Euro / patient-year |
| Empagliflozin (Matched to Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA)) | Direct Healthcare Cost | Inpatient | 1546 Euro / patient-year |
| Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched) | Direct Healthcare Cost | Medication | 3575 Euro / patient-year |
| Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched) | Direct Healthcare Cost | Total | 6851 Euro / patient-year |
| Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched) | Direct Healthcare Cost | Inpatient | 2094 Euro / patient-year |
| Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) (Matched) | Direct Healthcare Cost | Outpatient | 1181 Euro / patient-year |
Comparison: Total cost comparison.p-value: <0.001Bang and Tsiatis
Comparison: Total cost comparison.p-value: <0.001Bang and Tsiatis
Comparison: Total cost comparison.p-value: <0.001Bang and Tsiatis
Comparison: Inpatient cost comparisonp-value: <0.001Bang and Tsiatis
Comparison: Inpatient cost comparison.p-value: <0.001Bang and Tsiatis
Comparison: Inpatient cost comparisonp-value: 0.126Bang and Tsiatis
Comparison: Outpatient cost comparison.p-value: <0.001Bang and Tsiatis
Comparison: Outpatient cost comparison.p-value: <0.001Bang and Tsiatis
Comparison: Outpatient cost comparison.p-value: <0.001Bang and Tsiatis
Comparison: Medication cost comparison.p-value: <0.001Bang and Tsiatis
Comparison: Medication cost comparison.p-value: <0.001Bang and Tsiatis
Comparison: Medication cost comparison.p-value: <0.001Bang and Tsiatis
Primary
Healthcare Resource Utilization
Healthcare resource utilization includes hospitalizations, hospital stays. outpatient visits, and rehabilitation stays.
Time frame: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.
Population: Relevant data for the outcome measure were not collected in the GMQ dataset because GWQ´s quality assurance decided not to integrate several sub-datasets into GWQ´s dataset due to heterogeneity and low coding-quality of out-patient diagnoses and high variability in size, structure, and quality of specific items in individual sickness funds data.
Secondary
Indirect Healthcare Costs (Including Indirect Costs of Days Absent From Work)
Indirect healthcare costs (including indirect costs of days absent from work) includes indirect costs for hospitalization, outpatient visits, absent from work, and rehabilitation stays.
Time frame: Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.
Population: Relevant data for the outcome measure were not collected in the GMQ dataset because GWQ´s quality assurance decided not to integrate several sub-datasets into GWQ´s dataset due to heterogeneity and low coding-quality of out-patient diagnoses and high variability in size, structure, and quality of specific items in individual sickness funds data.