The Food and Drug Administration has approved a triple-combination tablet (Trijardy XR), comprising empagliflozin (Jardiance), linagliptin (Tradjenta), and extended-release metformin hydrochloride, for the treatment of adults with type 2 diabetes.
Trijardy XR will be available in four different dosages and is indicated as a once-daily treatment, together with diet and exercise, for adults who are already on treatment for type 2 disease but require additional agents to attain healthy hemoglobin A1c targets, according to a statement released by Eli Lilly, which will market the newly approved treatment together with Boehringer Ingelheim.
"Type 2 diabetes is a complex disease that often requires the use of multiple antidiabetic medications to improve glycemic control. Having three different diabetes medications in a single tablet is an important advance in diabetes treatment," Ralph DeFronzo, MD, professor and diabetes division chief at the University of Texas Health San Antonio, said in the release.
The approval of the triple-combination treatment was based on findings from two randomized, open-label trials that assessed the bioequivalence of empagliflozin, linagliptin, and extended-release metformin hydrochloride fixed-dose combination tablets, as well as their individual components. In addition, the trials established that the safety profile of the combination therapy was similar to the safety profiles of the components, the statement said.
Lactic acidosis, pancreatitis, and heart failure are among the side effects associated with the combination therapy, with upper respiratory tract infection and gastroenteritis among the most common. Serious side effects include dehydration, ketoacidosis, kidney problems, urinary tract and vaginal yeast infections, and hypoglycemia.
The combination product is contraindicated for people with kidney problems and end-stage renal disease or who are on dialysis; have metabolic acidosis or diabetic ketoacidosis; or are allergic to empagliflozin, linagliptin, or metformin.
This story originally appeared on MDedge.com.
Cite this: FDA OKs New Triple-Combo Pill, Trijardy XR, for Type 2 Diabetes - Medscape - Jan 28, 2020.