Comparative Effectiveness of Empagliflozin in the US

Registered clinical trial record on ClinicalTrials.gov (NCT03363464). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results. Status: active not recruiting. Study type: observational. Sponsor: Boehringer Ingelheim. Conditions: Diabetes Mellitus, Type 2. Interventions: Empagliflozin, DPP-4 inhibitor, GLP-1 receptor agonist. 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. Primary outcome measures: 3-point major adverse cardiovascular events (MACE); Hospitalization for heart failure (specific, based on primary inpatient diagnosis code); Hospitalization for heart failure (broad, based on any inpatient diagnosis code); Modified MACE; Composite of MI or stroke hospital admission for heart failure; All-cause mortality. Eligibility: 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 exclusion criteria apply.