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New Diabetes Drug Jardiance (Empagliflozin) Now Available in U.S.
Jardiance tablets (empagliflozin, Boerhinger Ingelheim/Eli Lilly) are now available by prescription in U.S. pharmacies. The FDA approved the treatment on August 1, 2014, as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes.
Jardiance is not for patients with type-1 diabetes or for patients with diabetic ketoacidosis.
Empagliflozin is a sodium glucose co-transporter-2 (SGLT2) inhibitor. It works by blocking the reabsorption of glucose in the kidney, thereby increasing glucose excretion and lowering blood glucose levels in adults with type-2 diabetes who have elevated blood glucose levels.
Patients should not take Jardiance if they have severe kidney problems or are on dialysis, or if they are allergic to empagliflozin or to any of the ingredients in Jardiance. The drug can cause some people to become dehydrated, which may lead to a drop in blood pressure and may cause patients to feel dizzy or faint.
The FDA’s approval of Jardiance (empagliflozin) was based on results from a large clinical program consisting of more than 10 multinational clinical trials and more than 13,000 adults with type-2 diabetes. Phase III studies showed that empagliflozin significantly reduced hemoglobin A1c (a measure of the average blood glucose level over the past 2 to 3 months) after 24 weeks as a stand-alone treatment or in combination with background treatments, including metformin, sulfonylureas, insulin, and pioglitazone.
Although Jardiance is not approved for lowering weight or blood pressure, modest reductions in both weight and systolic blood pressure were observed in clinical trials.
The most common adverse events associated with empagliflozin were urinary tract infections and vaginal yeast infections. Hypoglycemia was more common in patients treated with the combination of empagliflozin and sulfonylurea or insulin.
Approximately 29 million Americans and an estimated 382 million people worldwide have type-1 or type-2 diabetes. Type-2 diabetes is the most common form, accounting for an estimated 85% to 95% of all diabetes cases.
Jardiance is available as 10-mg or 25-mg tablets, administered once daily.