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Drug Safety Evaluations

A Safety Evaluation of Empagliflozin for the Treatment of Type 2 Diabetes

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Pages 393-402 | Received 19 Nov 2015, Accepted 21 Dec 2015, Published online: 02 Feb 2016
 

ABSTRACT

Introduction: Empagliflozin is a sodium glucose co-transporter 2 inhibitor used to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) by enhancing urinary glucose excretion. Empagliflozin is effective at lowering glycosylated hemoglobin and was recently proven superior to placebo for reduction of cardiovascular disease (CVD) risk. As with any new drug, there are safety considerations that inform its potential use in patients with T2DM.

Areas Covered: Here, we evaluate the safety of empagliflozin and provide an expert opinion as to its current and future role in the treatment of patients with T2DM. A search of the English language literature was performed using PubMed search terms: “empagliflozin”, “sodium glucose cotransporter 2 inhibitors”, and “drug safety”. Articles and bibliographies relevant to the subject were reviewed and additional references known to the authors were included.

Expert Opinion: The evidence for empagliflozin is robust with regard to glycemic efficacy and safety. Low risk of hypoglycemia, absence of weight gain, and demonstrated cardiovascular risk reduction support its consideration as a first line medication in addition to metformin for patients with T2DM and CVD. Ongoing trials will continue to address the safety and efficacy of empagliflozin and expand our clinical knowledge of this medication.

Declaration of interest:

I Neeland is supported by grant 1K23DK106520-01 from the National Institute of Diabetes and Digestive and Kidney Diseases/National Institutes of Health and as a Dedman Family Scholar in Clinical Care at UT Southwestern. D McGuire has received research support and consultancy honoraria from Boehringer Ingelheim, Lilly USA, Jansen Research, Sanofi Aventis, Genentech, Merk, Daiichi Sanyko, Novo Nordisk, GlaxoSmithKline, Takeda, Bristol Myers-Squibb, AstraZeneca, Orexigen, Lexicon, Eisai, Pfizer, Regeneron and Genfit. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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