Empagliflozin (Jardiance), a sodium glucose co-transporter 2 (SGLT2) inhibitor, was recently approved to treat type 2 diabetes in addition to diet and exercise, the FDA announced last week.
Safety and effectiveness of empagliflozin were evaluated in 7 clinical trials involving 4,480 patients with type 2 diabetes, which showed that the drug improved HbA1c levels compared to placebo, according to an FDA press release. The most common side effects are urinary tract infections and female genital infections. The drug can cause dehydration, leading to hypotension that can result in dizziness and/or fainting and a decline in renal function. Patients who are elderly, have impaired renal function, or are on diuretics appeared to be more susceptible to this risk.
Empagliflozin has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, sulfonylureas, pioglitazone, and insulin. It should not be used to treat people with type 1 diabetes, diabetic ketoacidosis, severe renal impairment, or end-stage renal disease. The FDA is requiring 4 postmarketing studies to investigate cardiovascular outcomes and pediatric use.