Empagliflozin for the treatment of Type 2 diabetes

Abstract

Diabetes and its complications account for a significant healthcare burden. There is increasing prevalence of diabetes and newer drugs are being investigated to improve outcomes. Sodium–glucose cotransporter inhibitors (SGLT2 inhibitors) are a newer class of medications, which prevent renal reabsorption of glucose and hence help in glycaemic control without significant risk of hypoglycaemia. Two drugs, namely dapagliflozin and canagliflozin have gained approval and empagliflozin is one of the advanced agents of this class. Early trials with empagliflozin have shown a stable pharmacokinetic profile and pharmacodynamic effects with significant SGLT2 selectivity. Clinical trials have shown improvement in glycaemic control and other benefits including weight loss and lowering of blood pressure. Ongoing trials and surveillance will provide answers about cardiovascular benefits, risk of osteoporosis and cancer.

Keywords::

• cardiovascular
• empagliflozin
• renal proximal tubule
• SGLT2 inhibitors
• Type 2 diabetes

Financial & competing interests disclosure

Muralikrishna Gangadharan Komala is undertaking a project that is partly funded by Boehringer Ingelheim. 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.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Sodium glucose cotransporter 2 inhibitors are newer antidiabetic agents.

• Phase III trials have shown glycemic benefits, improvement in blood pressure and weight loss.

• Short-term trials reveal no significant safety concerns although genital fungal infections remain a concern.

• Cardiovascular outcomes, risk of cancer and effects on bone morphology remain to be answered.

• US FDA has rejected empagliflozin new drug application based on deficiencies at its main manufacturing facility.

• The success of empagliflozin depends on correction of deficiencies identified by the FDA and successful reapplication.