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New drug combines dapagliflozin, saxagliptin, and metformin.
The FDA has approved Qternmet XR (dapagliflozin, saxagliptin, and metformin hydrochloride), which combines a sodium-glucose cotransporter 2 (SGLT2) inhibitor, a dipeptidyl peptidase-4 (DPP4) inhibitor, and a biguanide combination product to improve glycemic control in adults with type 2 diabetes mellitus.
According to Astrazenica, the approval is based on two phase 3 trials that evaluated combinations of dapagliflozin and saxagliptin along with metformin over 24 weeks in patients with inadequately-controlled type 2 diabetes.
The company points out that, in one trial, treatment with 5 mg of dapagliflozin and 5 mg saxagliptin in addition to metformin demonstrated statistically-significant decreases in average blood glucose levels and an increase in patients achieving recommended A1c levels. When dosages were increased to 10 mg in the second trial, both statically-significant decreases in average blood glucose levels and an increase in patients achieving A1c were amplified.
Qternmet XR is not indicated for treatment of type 1 diabetes mellitus or diabetic ketoacidosis, and is only to be initiated in patients currently taking metformin.
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The drug is contraindicated for patients with a history of serious hypersensitivity to any of the drug constituents including anaphylaxis, angioedema, or exfoliative skin conditions; moderate-to-severe renal impairment, end-stage renal disease, or patients on dialysis; acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma.
Before administering, the patient’s renal status should be analyzed, with follow-ups conducted periodically after treatment initiation. Total daily starting dose of Qternmet XR is to be based upon the patient’s current regiment, effectiveness, and tolerability, with recommended starting dose at 5 mg dapafgliflozin/5 mg saxagliptin/1000 mg or 2000 mg metformin hydrochloride. Maximum recommended dose is 10 mg dapagliflozin, 5 mg saxagliptin, and 2000 mg of metformin hydrochloride.
The tablet is to be taken once daily in the morning with food and should be swallowed whole.
The most common adverse reactions of Qternmet XR include upper respiratory tract infection, urinary tract infection, and dyslipidemia.