Jardiance (empagliflozin) is the third authorised drug in the SGLT2 group for the treatment of type 2 diabetes in adults. The recommended starting dose is 10 mg once daily, but it may be increased to 25 mg once daily, depending on the kidney function. Generally, empagliflozin has only been used to a limited extent in patients with a GFR <45-60 ml/min, and treatment should not be started in patients with a GFR <60 ml/min.
Empagliflozin was shown to be better than placebo, and at least as effective as comparator drugs, at reducing the levels of HbA1c when used alone or in combination with other antidiabetic drugs or insulin. There are no clinically relevant differences in the total number of adverse events between empagliflozin and placebo, with the exception of hypoglycaemia (when used as add-on to sulphonylurea and insulin) and genital infections. There is no evidence that empagliflozin can prevent clinically relevant endpoints such as macro and micro vascular complications and death.
It is IRF's overall assessment that empagliflozin should not be first-line treatment for type 2 diabetes. In a choice between empagliflozin and other SGLT2 inhibitors and a sulphonylurea as add-on therapy to metformin, the significantly higher treatment price and lack of long-term data on relevant clinical endpoints should be considered. Empagliflozin and other SGLT2 inhibitors can be used as add-on to metformin in patients who despite careful dose titration experience hypoglycaemia during treatment with sulphonylurea, but the DPP-4 inhibitors are probably preferable in this situation due to the lower treatment price and the differences in specific adverse events.
Jardiance was marketed on 27 July 2014 and has general reimbursement.