What are the indications for empagliflozin in the treatment of type 2 diabetes mellitus (DM)?

Updated: Oct 23, 2019
  • Author: Romesh Khardori, MD, PhD, FACP; Chief Editor: George T Griffing, MD  more...
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Answer

Like dapagliflozin, empagliflozin is also approved as an adjunct to diet and exercise to improve glycemic control. The drug’s safety and effectiveness were evaluated in 7 clinical trials with 4480 patients with type 2 diabetes. The pivotal trials showed that empagliflozin improved hemoglobin A1c levels compared with placebo. [197, 198]  In late 2016, the FDA also approved empagliflozin for a new indiction, specifically, the prevention of cardiovascular disease–related death in adults with type 2 diabetes who also have cardiovascular disease. [207, 208]  The new approval was based on results from the (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME), which included more than 7000 patients. [209]


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