First Dapagliflozin-Metformin Combination Drug Now FDA-Approved

First Dapagliflozin-Metformin Combination Drug Now FDA-Approved

shutterstock_120083020Pharmaceutical giant AstraZeneca has just announced the US Food and Drug Administration‘s final approval of their oral, once-daily dapagliflozin and metformin hydrochloride extended-release (Xigduo XR) treatment for type 2 diabetes mellitus. While the most important and effective interventions in type 2 DM consist of positive lifestyle and diet modifications, many patients eventually need pharmacologic support in the form of glucose-lowering medications.

“The addition of Xigduo XR to our U.S. diabetes portfolio is further evidence of AstraZeneca’s commitment to develop new treatment options for patients with type 2 diabetes, said Elisabeth Björk, Head of Cardiovascular & Metabolism, Global Medicines Development for AstraZeneca. “The approval of once-daily Xigduo XR provides prescribers and adult patients with another treatment choice, supporting a more personalized approach to disease management.”

AstraZeneca’s Xigduo XR is a combination drug composed of a pair of anti-hyperglycemic agents that complement each other’s mode of action:

  • dapagliflozin (Farxiga), a sodium-glucose cotransporter 2 (SGLT2) inhibitor that works to excrete excess blood sugar through the kidneys
  • metformin hydrochloride, a biguanide in an extended-release formulation

This once-daily combination drug is the first of its kind to achieve FDA approval. Patients are encouraged to take this drug only as an adjunct therapy to doctor-recommended positive diet and lifestyle choices to enhance blood glucose control.

Xigduo XR is contraindicated in type 1 DM and in cases of diabetic ketoacidosis. One of the notable adverse reactions to this drug is lactic acidosis — a metabolic emergency that develops from systemic metformin accumulation. Other contraindications include moderate-severe renal impairment, history of allergy to either dapagliflozin or metformin HCl, and metabolic acidosis.

In other diabetes news, a recent study was published online in JAMA Internal Medicine which revealed Metformin treatment in patients with diabetes reduces the necessity for follow-up intensification treatments. The study found that compared to other oral glucose-lowering drugs, metformin yielded a lower percentage of patients that required later insulin treatment. The study, entitled, “Initial Choice of Oral Glucose-Lowering Medication for Diabetes Mellitus: A Patient-Centered Comparative Effectiveness Study” comes from a team of researchers at Brigham and Women’s Hospital and Harvard Medical School, Boston.

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