Diabetes Mellitus, Type 2
Conditions
Brief summary
Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with several previous cardiovascular outcomes trials, which failed to demonstrate an association with a higher or a lower risk of cardiovascular outcomes associated with members of other recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a reduced risk of hospitalization for heart failure, cardiovascular mortality, and all-cause mortality. However, these and other findings arising from an extensive clinical trial program aimed at evaluating the efficacy and safety profile for empagliflozin have yet to be demonstrated in a non-trial environment. This study aims to investigate the transferability of the effects demonstrated in dedicated randomized clinical studies to a broader population under real world conditions.
Interventions
DRUGEmpagliflozin
Empagliflozin
DRUGDPP-4 inhibitor
dipeptidyl peptidase-4 inhibitor
DRUGGLP-1 receptor agonist
Glucagon-like peptide-1 receptor agonist
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>= 18 years old for Marketscan and Optum, and \>=65 years old for Medicare only * Patients initiating empagliflozin or a DPP-4 inhibitor within the study period. Initiation was defined as no use of SGLT-2 inhibitors (canagliflozin, dapagliflozin, ertugliflozin) or DPP-4 inhibitors in the previous 12 months. * Restriction to patients with a diagnosis of T2DM (ICD-9 Dx code of 250.x0 or 250.x2; ICD-10 Dx code of E11.x) in the 12 months prior to drug initiation.
Exclusion criteria
* Patients with missing or ambiguous age or sex information. * All patients who have less than 12 months of continuous registration in the database prior to initiation of empagliflozin or a DPP-4 inhibitor will be excluded. * Patients with type 1 diabetes mellitus (T1DM) defined as at least 1 inpatient or outpatient codes in the 12 months prior to drug initiation. * Secondary diabetes, and gestational diabetes in the 12 months prior to drug initiation * History of cancer in the 5 years prior to drug initiation * End-stage renal disease (ESRD) in the 12 months prior to drug initiation * HIV diagnosis or treatment in the 12 months prior to drug initiation * Organ transplant in the 12 months prior to drug initiation * Patients that were in nursing homes in the 12 months prior to drug initiation * Patients with concomitant SGLT-2 inhibitor and DPP-4 inhibitor initiation will also be excluded. * Patients initiating more than one DPP-4i on cohort entry date will additionally be excluded Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-point major adverse cardiovascular events (MACE) | 60 months | i.e., non-fatal myocardial infarction (MI), non-fatal stroke, or cardiovascular (CV) mortality; as well as each individual component: * Hospital admission for MI (for purposes of this individual component, fatal MI is included) * Hospital admission for stroke (for purposes of this individual component, fatal stroke is included) * CV mortality |
| Hospitalization for heart failure (specific, based on primary inpatient diagnosis code) | 60 months | — |
| Hospitalization for heart failure (broad, based on any inpatient diagnosis code) | 60 months | — |
| Modified MACE | 60 months | i.e., composite of MI, stroke or all-cause mortality |
| Composite of MI or stroke hospital admission for heart failure | 60 months | — |
| All-cause mortality | 60 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Coronary revascularization procedure | 60 months |
| Hospitalization for unstable angina | 60 months |
| Composite of MI, stroke, unstable angina hospitalization or coronary revascularization | 60 months |
| End-stage renal disease (ESRD) | 60 months |
| Bone fracture | 60 months |
| Diabetic ketoacidosis (Inpatient, primary position) | 60 months |
| Diabetic ketoacidosis (Inpatient, any position) | 60 months |
| Severe hypoglycemia | 60 months |
| Urinary tract cancers | 60 months |
| Lower-limb amputation | 60 months |
| Acute kidney injury (Inpatient, primary) | 60 months |
| Acute kidney injury (Inpatient, any position) | 60 months |
Countries
United States
Outcome results
None listed