The US Food and Drug Administration (FDA) gave approval to AstraZeneca for the once a day tablet, XIGDUO XR, used to treat type 2 diabetes. This treatment is a combination of metformin hydrochloride extended release and dapagliflozin, intended for adults living with this disease.
At this time, XIGDUO XR is not only the first but also the only once a day combination tablet of an metformin HCI extended release and SGLT2 inhibitor to be approved within the United States. However, medical professionals continue to stress the benefit of diet and exercise along with XIGDUO XR as a means of improving glycemic control adults with type 2 diabetes.
In addition, the FDA notes that XIGDUO XR is not recommended for type 1 diabetes or diabetic ketoacidosis. In support, the packaged product carries a warning for a rare but very serious metabolic complication called lactic acidosis caused by an accumulation of metformin.
There is also a contradiction between XIGDUO XR and patients who have moderate to severe renal impairment, as well as those with metabolic acidosis, to include diabetic ketoacidosis, and a history of sensitivity to metformin HCI or dapagliflozin.
In a statement from Elisabeth Bjork, head of Cardiovascular & Metabolism, Global Medicines Development, AstraZeneca, adding XIGDUO XR to the portfolio of other US diabetes treatments further indicates the company’s dedication to developing new treatment options for people who live with this disease.
XIGDUO XR to treat adults with type 2 diabetes is already approved in Australia, coupled with following a healthy diet and daily exercise. According to FDA guidelines, this new treatment is approved with multiple dosage strengths to include 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg, depending on each patient’s treatment regimen as determined by the treating doctor.
In addition, XIGDUO XR is to be taken only once a day, each morning with food. After prescribing the medication, doctors will monitor each patient for signs of developing hypotension, one of the possible side effects and something that older patients and those with impaired renal impairment are more prone to.
While there are potential risks, XIGDUO XR is being hailed as a high effective drug that is extremely helpful to adults with type 2 diabetes.