Category: Federal Forum Posters
Purpose: Sodium-glucose co-transporter 2 (SGLT2) inhibitors, including empagliflozin, are newer antidiabetic agents. Combined safety data from SGLT2 inhibitor phase III trials concluded patients age 75 years or greater were at increased risk of adverse drug events and there is increasing concern for groin infections, including Fourneir’s gangrene. Veterans generally have more complex medical profiles than the civilian population and an increased risk for adverse events. The objective of this study is to compare empagliflozin volume depletional adverse events (composite of hypotension, syncope, dehydration, fall, or fracture) and groin infections in veterans age 65 years or greater to less than 65 years.
Methods: This retrospective database and chart review study was submitted to the Institutional Review Board for approval. The Veterans Health Administration Corporate Data Warehouse will identify patients within the Sunshine Healthcare Network age greater than 18 years old, diagnosed with type 2 diabetes mellitus, and receiving a prescription for empagliflozin between January 1, 2015 and June 1, 2018. Baseline data to be collected includes age, race, weight, HbA1c at start of empagliflozin therapy, empagliflozin dosage, complications of diabetes, comorbidities, and concomitant antidiabetic and antihypertensive medications. Data to be collected for patients admitted to the emergency room for volume depletional adverse effects includes admitting diagnosis, labs, and vitals. Development of groin infections while taking empagliflozin will be assessed via documented adverse drug events, emergency room admissions, and chart review of patients with empagliflozin prescriptions stopped during the study period. Baseline characteristics reported as a mean value will be compared using two-sample t-tests. The composite outcome and baseline characteristics reported as a proportion of the cohort having the characteristics will be compared between two patient cohorts with a chi-square test of independence: (1) age 65 years or greater, and (2) age less than 65 years.
Results: not applicable
Conclusion: not applicable
Sarah Rinehart– Pharmacy Resident, James A. Haley Veterans Hospital, Tampa, FL