Cardiovascular Diseases, Diabetes Mellitus, Type 2
Conditions
Brief summary
Evaluation of clinical outcomes (specifically cardiovascular outcomes like hospitalization for heart failure), and healthcare cost, and resource utilization, among patients on empagliflozin as an add-on therapy to metformin versus patients on sulfonylureas as an add-on therapy to metformin in patients with Type 2 Diabetes (T2D) and Cardiovascular Disease (CVD).
Interventions
DRUGempagliflozin
empagliflozin
DRUGmetformin
metformin
DRUGsulfonylurea
sulfonylurea
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prevalent metformin use + initiation of empagliflozin OR prevalent metformin use + initiation of sulfonylurea * ≥18 years of age at index date during study observation * ≥1 inpatient and/or ≥ 2 outpatient claims denoting T2D diagnosis (in any position) in the 12 months prior to index date * ≥1 inpatient and/or ≥2 outpatient claims denoting CVD (in any position) diagnosis in the 12 months prior to index date * ≥2 months post-index date * ≥12 months of no exposure to T2D medications in the pre-index period (excluding metformin in both arms) * ≥12 months of continuous enrolment prior to index date
Exclusion criteria
* Diagnosis of Type 1 Diabetes, secondary, or gestational diabetes in the 12 months prior to index date * Diagnosis of severe comorbidities including malignancy, end-stage renal disease, human immunodeficiency virus, Hepatitis C infection, or organ transplant in the 12 months prior to index date * Admission to nursing home in the 12 months prior to index date
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of first hospitalization for congestive heart failure (HHF) | up to 5 years and 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of filled drugs | up to 5 years and 3 months | — |
| Outpatient visits | up to 5 years and 3 months | — |
| Length of stay | up to 5 years and 3 months | — |
| Emergency department (ED) visits | up to 5 years and 3 months | — |
| All cause cost | up to 5 years and 3 months | total cost of care, divided by medical (inpatient costs, outpatient costs, emergency costs) and pharmacy costs (all reported in Per Patient Per Month (PPPM) costs) |
| Hospitalizations | up to 5 years and 3 months | — |
Countries
United States
Outcome results
None listed