Type 2 diabetes now accounts for 90%of all cases of diabetes diagnosed in the US, affecting 26 million people, who are at risk for developing serious complications from high blood sugar levels. These include heart disease, stroke, and blindness, as well as damage to their nerves and kidneys. As a result, the FDA has just approved the drug Jardiance (empagliflozin) as a means of helping adults with type-2 diabetes manage and improve blood sugar levels when taken in conjunction with proper diets and exercise, although it can be taken alone, as well as with other type 2 diabetes therapies including metformin, sulfonylureas, pioglitazone, and insulin. It should not, however, should not be used: to treat people with type 1 diabetes; in those who have increased ketones in their blood or urine (diabetic ketoacidosis); and in those with severe renal impairment, end stage renal disease, or by dialysis patients.
According to Curtis J. Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Jardiance is a sodium glucose co-transporter 2 (SGLT2) inhibitor that works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels.”
The drug’s safety and effectiveness were evaluated in seven clinical trials with 4,480 patients with type 2 diabetes receiving Jardiance. The pivotal trials showed that Jardiance improved hemoglobin A1c levels (a measure of blood sugar control) compared to placebo.
While the most common side effects seen during clinical trials of Jardiance were urinary tract infections and infections of female genitalia, doctors also noted that the pills can cause “dehydration, leading to a drop in blood pressure (that can result in dizziness and/or fainting) and a decline in renal function, particularly in elderly, patients with impaired renal function, and patients on diuretics to treat other conditions.
To learn more consult your endocrinologist, or contact the FDA consumer information line at 888 INFO-FDA
Note: Glucose (blood sugar) is derived from carbohydrate foods, and is the primary source of energy used by the body. Insulin is a hormone produced by the pancreas and released into the blood stream to help cells use the glucose.