Trade names Jardiance Routes ofadministration by mouth | AHFS/Drugs.com jardiance ATC code A10BK03 (WHO) | |
Pregnancycategory US: C (Risk not ruled out) Legal status In general: ℞ (Prescription only) | ||
Empagliflozin (trade name Jardiance) is a drug of the gliflozin class, approved for the treatment of type 2 diabetes in adults in 2014. It was developed by Boehringer Ingelheim and Eli Lilly and Company.
Contents
Empagliflozin is an inhibitor of the sodium glucose co-transporter-2 (SGLT-2), and causes sugar in the blood to be excreted by the kidneys and eliminated in urine.
Medical use
Empaglifozin in people with type 2 diabetes reduces the risk of death from cardiovascular disease in those with a previous history of cardiovascular disease.
Side effects
When taken in dosages of 10 or 25 mg once a day, the incidence of adverse events was similar to placebo. However, there was a higher frequency of urinary tract infections.
There are concerns it may increase the risk of diabetic ketoacidosis (DKA). Interestingly, DKA may develop despite only mildly elevated blood glucose levels in people taking SGLT-2 inhibitors, potentially complicating the diagnosis.
Mode of action
Empagliflozin is an inhibitor of the sodium glucose co-transporter-2 (SGLT-2), which is found almost exclusively in the proximal tubules of nephronic components in the kidneys. SGLT-2 accounts for about 90 percent of glucose reabsorption into the blood. Blocking SGLT-2 reduces blood glucose by blocking glucose reabsorption in the kidney and thereby excreting glucose (i.e., blood sugar) via the urine.
Regulatory status
As of May 2013, Boehringer and Lilly had submitted applications for marketing approval to the European Medicines Agency and the U.S. Food and Drug Administration (FDA). The drug was approved in Europe in May 2014 and was approved by the FDA in August 2014. The FDA required four postmarketing studies: a cardiovascular outcomes trial, and two studies in children, and a toxicity study in animals related to the pediatric trials.