Another SGLT2 inhibitor for type 2 diabetes is approved

August 7, 2014

FDA has approved empagliflozin (Jardiance, Boehringer Ingelheim Pharmceuticals) as another option for adult patients with type 2 diabetes.

 

FDA has approved empagliflozin (Jardiance, Boehringer Ingelheim Pharmceuticals) as another option for adult patients with type 2 diabetes.

Empagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, should be used in addition to diet and exercise to improve glycemic control in patients with type 2 diabetes. It can be used as stand-alone therapy or in combination with other type 2 diabetes treatments.

This class of medications, which also includes canagliflozin (Invokana, Janssen Pharmaceuticals) and dapagliflozin (Farxiga, AstraZeneca), works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels.

Empagliflozin was evaluated in seven clinical trials of approximately, 4,500 patients with type 2 diabetes. The drug was shown to improve hemoglobin A1c levels compared to placebo. The studies examined the SGLT2 inhibitor as monotherapy and in combination with metformin, sulfonylureas, pioglitazone, and insulin.

FDA warns that empagliflozin should not be used for patients with type 1 diabetes, diabetic ketoacidosis, and individuals with severe renal impairment, including end-stage renal failure.

Four post-marketing studies for empagliflozin are required, including completion of an ongoing cardiovascular outcomes trial, a pediatric study of pharmacokinetics and pharmacodynamics, a pediatric study to see the effect on bone health and development, and an animal toxicity study focusing on renal development, bone development, and growth.

The most common side effects reported have been urinary tract infections and female genital infections. Empagliflozin can cause dehydration, resulting in dizziness and fainting. It also can result in renal function decline.