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Empagliflozin (Jardiance) Gets FDA Nod for Treatment of Type-2 Diabetes

SGLT2 inhibitor lowers blood glucose levels

The FDA has approved empagliflozin (Jardiance, Boehringer Ingelheim) as an addition to diet and exercise to improve glycemic control in adults with type-2 diabetes.

Empagliflozin is a sodium glucose co-transporter 2 (SGLT2) inhibitor. It works by blocking the reabsorption of glucose by the kidney, thereby increasing glucose excretion, and by lowering blood glucose levels in diabetics who have elevated blood glucose levels. The drug’s safety and effectiveness were evaluated in seven clinical trials involving a total of 4,480 patients with type-2 diabetes. The pivotal trials showed that empagliflozin improved hemoglobin A1c levels (a measure of blood sugar control) compared with placebo.

Empagliflozin has been studied as a stand-alone therapy and in combination with other type-2 diabetes treatments, including metformin, sulfonylureas, pioglitazone, and insulin. The drug should not be used to treat patients with type-1 diabetes, those with diabetic ketoacidosis, those with severe renal impairment or end-stage renal disease, or those receiving dialysis.

The FDA is requiring four post-marketing studies of empagliflozin:

  • Completion of an ongoing cardiovascular outcomes trial
  • A pediatric pharmacokinetic/pharmacodynamic study
  • A pediatric safety and efficacy study, in which the effect on bone health and development will be evaluated
  • A nonclinical (animal) juvenile toxicity study, with a focus on renal development, bone development, and growth

Empagliflozin can cause dehydration, leading to hypotension, which can result in dizziness and/or fainting and a decline in renal function. The elderly, patients with impaired renal function, and patients receiving diuretics to treat other conditions appeared to be more susceptible to this risk.

The most common adverse effects of treatment with empagliflozin are urinary tract infections and female genital infections.

Type-2 diabetes affects approximately 26 million people and accounts for more than 90% of diabetes cases diagnosed in the U.S. Over time, high blood sugar levels can increase the risk of serious complications, including heart disease, blindness, and nerve and kidney damage.

Source: FDA; August 1, 2014.

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