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

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.

Effect of Empagliflozin on Tacrolimus-Induced Pancreas Islet Dysfunction and Renal Injury

“…The glucose-lowering effect of Em in type 2 DM is that inhibiting the SGLT-2 prevents glucose reabsorption and subsequently induces the elimination of filtered glucose via urine (27,28). Therefore, we tested whether a similar effect of SGLT-2 inhibitor can be observed in TACinduced DM.…”

Efficacy and Safety of Addition of Empagliflozin in Diabetic Patients Uncontrolled With Glimepiride + Metformin + Teneligliptin

“…23,24 The present study demonstrated that add-on empagliflozin therapy can significantly decrease fasting and postprandial blood glucose levels in T2DM patients with inadequate response to triple drug therapy. A significant improvement in HbA1c% was noted within 3 months of treatment and a remarkable proportion of the subjects (46.34%) achieved HbA1c levels <0.7%.…”

“…23,24 SGLT2 are transporter molecules that facilitates the reabsorption of 90% of the filtered glucose in the early proximal tubule. Hence, the inhibition of SGLT2 significantly reduces the reabsorption of filtered glucose, resulting in the excess excretion of glucose in the urine.…”

“…Robust evidence substantiates the glycemic efficacy and safety of empagliflozin. 24 A meta-analysis of randomized controlled trials by Devi et al (2017) have concluded on the efficacy and safety of empagliflozin as monotherapy and add-on to exciting diabetes pharmacotherapy for the treatment of T2DM. 21 The study showed that the drug significantly improved HbA1c levels and fasting plasma glucose levels when used as an add-on to existing drugs.…”

Mean Centering Method for determination of Empagliflozin and Metformin

“…® is composed of empagliflozin from the gliflozin class that was recently approved for the treatment of type 2 diabetes as a sodium glucose co-transporter 2 inhibitor enhancing urinary glucose excretion [1] and metformin which is the drug of choice in mixed therapy for type 2 diabetes. Only one chromatographic method [2] and one spectrophotometric method [3] were developed for its pharmaceutical analysis.…”