Nutrition, Metabolism and Cardiovascular Diseases
Acute renal failure with sodium-glucose-cotransporter-2 inhibitors: Analysis of the FDA adverse event report system database
Section snippets
Background
Sodium-glucose-cotransporter-2 (SGLT2) inhibitors have been approved in recent years for use in the treatment of type II diabetes mellitus (T2DM). Currently approved agents include canagliflozin, dapagliflozin, and empagliflozin. These agents have all proven effective treating T2DM in terms of HbA1c reduction, as well as additionally beneficial in terms of blood pressure reduction, weight loss, and improved lipid profile [1]. The large randomized control trial EMPA-REG demonstrated that
Methods
We analyzed adverse event cases submitted to FAERS between January 2013 and September 2016. FAERS is a database that contains information on adverse event reports submitted to FDA. The database is designed to support the FDA's post-marketing safety surveillance program for medication. Reports of adverse events are submitted by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, lawyers and others), and drug manufacturers
Results
During the period evaluated, 3,832,015 unique adverse event cases were reported in FAERS. Of these, 18,915 reports involved the use of SGLT2-inhibitors. Individuals reported with SGLT2-inhibitor associated adverse events were on average 58 years of age, and weighed 95 kg. SGLT2-inhibitors were reportedly associated with ARF in 1224 cases (6.5%), and were judged to be the “primary” or “secondary” cause of the adverse event in almost all cases (96.8%). Many of the cases reporting SGLT2-inhibitor
Discussion
The results of this study show that in the FDA adverse events database, SGLT2-inhibitors are associated with increased odds of reporting of acute renal failure. The strength of this association (ROR 2.88, 95% CI 2.71–3.05, p < 0.001) met widely accepted and validated criteria indicating a likely signal between these medications and acute renal failure, and the outcome of a large proportion of cases was deemed serious or led to new or prolonged hospitalization. The association between
Acknowledgments
No financial support was received for the conduct of the research and/or preparation of the article, and the authors have no conflict of interest to disclose.
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