The National Institute for Health and Care Excellence (NICE) has issued final appraisal determination (FAD) for the use of 5 mg Forxiga or dapagliflozin in type 1 Diabetes Mellitus patients with insulin in patients with inadequate glycemic control.
Dapagliflozin (Forxiga) is an oral antidiabetic medication that is now commonly used to treat patients with type 2 Diabetes Mellitus. For patients with type 1 diabetes mellitus, little options exist.
Because of its unique mechanism of action, dapagliflozin & other SGLT2 inhibitors were thought to be beneficial in controlling hyperglycemia in addition to insulin in patients with type 1 diabetes mellitus – theoretically though.
This theoretical beneficial effect has led investigators to study SGLT2 inhibitors in patients with type 1 Diabetes Mellitus.
Some of the recommendations made are mentioned here. However, till further solid recommendations are made, only the following group of patients may be advised dapagliflozin (or other SGLT2 inhibitors like empagliflozin).
Dapagliflozin in type 1 Diabetes Mellitus – which patients may benefit ¿
The Forxiga drug marketer cleared the use of dapagliflozin in patients with type 1 diabetes mellitus who have:
- An inadequate control despite optimal insulin therapy
- BMI (Body mass index) of 27 kg/m² or more
- Insulin requirement is more than 0.5 units/kg of body weight
- Patients have completed a structured education program that encompasses the following important points:
- Risk factors, signs and symptoms, and when to suspect diabetic ketoacidosis.
- How and when to monitor blood ketone levels
- What to do if the ketone levels are high
Start the treatment in a supervised diabetic clinic and monitor!!
All patients who are to be initiated on SGLT2 inhibitor treatment should be started the therapy in supervised diabetic clinics inside a hospital.
Furthermore, the glycated hemoglobin should be monitored at 3 and 6 months intervals.
Treatment may be discontinued if the glycemic control is not achieved. The manufacturer recommends discontinuing therapy if the glycated hemoglobin falls by less than 0.3% after six months of therapy.