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New treatment option for pediatric T2D
Roger Selvage 1123

New treatment option for pediatric T2D

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Young diabetic patient checks blood sugar level

Lauren Howell, PharmD

This past June, FDA approved the first new class of medicines to treat pediatric T2D since 2000. Previously limited to metformin, children 10 years or older with T2D now have another treatment option that can be used in addition to diet and exercise to improve blood glucose control.

Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) were originally approved in 2014 and 2015, respectively, as additions to diet and exercise to improve glucose control in adults with T2D. Since then, they have also gained approval for reducing the risk of CV-related death in adults with T2D and established CVD, and to reduce the risk of CV-related death and hospitalization for adults with heart failure.

Recommended dosage and administration

For both Jardiance and Synjardy, the dosing for the pediatric population matches that of the adult population.

The recommended dosage of Jardiance is 10 mg once daily in the morning, taken with or without food. For additional glycemic control, the dosage may be increased to 25 mg in patients tolerating Jardiance. In patients with an eGFR of <30 mL/min/1.73 m2, Jardiance is not recommended.

For Synjardy, the starting dose should be individualized based on the patient’s current regimen and renal function. The maximum recommended dosage is 25 mg/day of empagliflozin and 2,000 mg/day of metformin. Initiation of Synjardy is not recommended is patients with an eGFR of <45 mL/min/1.73 m2.

Synjardy is also available as an extended-release formulation, Synjardy XR, which is not approved for use in pediatric patients with T2D. For both medications, renal function should be assessed, and volume depletion should be corrected prior to initiation of therapy.

Efficacy and safety

The safety and efficacy of empagliflozin in children were studied in a double-blind, randomized, placebo-controlled trial. This trial included 157 patients between the ages of 10 years and 17 years with inadequately controlled T2D. Participants were assigned to one of three treatment arms and received either empagliflozin, a DPP-4 inhibitor (linagliptin), or a placebo.

Prior to beginning treatment for the trial, 51% of participants were taking metformin alone, 40% of participants were taking a combination of metformin and insulin, 3% of participants were taking insulin alone, and 6% of participants were not taking medication for diabetes. At week 26, the trial found that treatment with empagliflozin was superior in reducing hemoglobin A1C compared to a placebo. The patients treated with empagliflozin had an average 0.2% decrease in hemoglobin A1C compared with an average 0.7% increase in the participants taking a placebo. Additionally, patients treated with empagliflozin had reductions in fasting plasma glucose as compared to patients taking the placebo.

Overall, adverse effects in children treated with empagliflozin are similar to those seen in adults. However, one difference seen in the pediatric population is a higher risk of hypoglycemia among patients 10 years and older who are taking empagliflozin compared to placebo, regardless of whether they were taking other therapies for diabetes.

Other common adverse effects in those taking empagliflozin include UTIs and female fungal infections. The most common adverse effects in patients treated with metformin include diarrhea, nausea, and upset stomach.

Due to an increased risk of diabetic ketoacidosis, Jardiance and Synjardy are not recommended in patients with T1D. They are also not recommended to improve blood glucose control in patients with severe kidney problems. If patients had a previous serious allergic reaction to the medications, they should not continue to use them. Synjardy must not be used in patients with metabolic acidosis or diabetic ketoacidosis. ■



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