Comparative Effectiveness of Empagliflozin in the US
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| patients with T2DM initiating empagliflozin Type 2 diabetes mellitus |
Drug: Empagliflozin
Empagliflozin
Other Names:
|
| patients with T2DM initiating a DPP-4 inhibitor dipeptidyl peptidase-4 inhibitor treated patients |
Drug: DPP-4 inhibitor
dipeptidyl peptidase-4 inhibitor
|
| patients with T2DM initiating a GLP-1 receptor agonist Glucagon-like peptide-1 receptor agonist treated patients |
Drug: GLP-1 receptor agonist
Glucagon-like peptide-1 receptor agonist
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
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
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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 exclusion criteria apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bringham Women Hospital | Boston | Massachusetts | United States | 02120 |
Sponsors and Collaborators
- Boehringer Ingelheim
- Eli Lilly and Company
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1245.92