Edistride - Dapagliflozin

What is Edistride - Dapagliflozin used for and what is it used for?

Edistride is a medicine indicated for the treatment of adults with type 2 diabetes.

Edistride can be used on its own (monotherapy) when diet and exercise alone do not provide adequate control of blood glucose (sugar) levels in patients intolerant of metformin (another antidiabetic medicine).

Edistride can also be used as an adjunctive therapy in combination with other antidiabetic medicines, including insulin, when these medicines, together with diet and exercise, do not provide adequate diabetes control.

Edistride contains the active substance dapagliflozin. This medicine is the same as Forxiga, already authorized in the European Union (EU). The manufacturer of Forxiga has accepted that its scientific data can be used for Edistride ("informed consent").

How is Edistride - Dapagliflozin used?

Edistride is available as tablets (5 and 10 mg) and can only be obtained with a prescription. The recommended dose is 10 mg once a day. If Edistride is used in combination with insulin or medicines that promote the body's production of insulin, it may be necessary to reduce the dose to reduce the risk of hypoglycemia (low blood glucose concentration). Because the effects of Edistride depend on renal function, the effectiveness of the medicine is reduced in patients with renal dysfunction. Therefore, the use of Edistride is not recommended in patients with moderate or severe renal dysfunction. In patients with severe impairment of liver function a starting dose of 5 mg is recommended.

How does Edistride - Dapagliflozin work?

Type 2 diabetes is a disease in which the pancreas does not produce enough insulin to control the level of glucose in the blood or where the body is unable to use insulin effectively, which leads to increased levels of glucose in the blood.

The active substance in Edistride, dapagliflozin, works by blocking a protein in the kidneys called the type 2 sodium-glucose transporter (SGLT2). SGLT2 is a protein responsible for the reabsorption of glucose into the bloodstream (bloodstream) from urine, when blood is filtered through the kidneys. By blocking the action of SGLT2, Edistride induces the elimination of more glucose through the urine and, consequently, the reduction of the concentration of glucose in the blood.

What benefit has Edistride - Dapagliflozin shown during the studies?

Edistride used as monotherapy was compared with a placebo (a dummy treatment) in two studies involving 840 patients with type 2 diabetes. A third study compared Edistride with a sulphonylurea (glipizide), both administered in combination with metformin in 814 patients. Four other studies compared Edistride with a placebo, in the form of adjunctive therapy in combination with metformin, a sulphonylurea (glimepiride), a thiazolidinedione or insulin in 2 370 patients. In all the studies the main measure of effectiveness was the level in the blood of a substance called glycosylated hemoglobin (HbA1c), which gives an indication of the effectiveness of blood glucose control.

Edistride was more effective than placebo in reducing HbA1c levels when used both as monotherapy and in combination with other antidiabetic medicines. Used as monotherapy at a dose of 10 mg, Edistride decreased HbA1c levels by 0.66% more than placebo after 24 weeks. In combination with other antidiabetic medicines, Edistride 10 mg decreased HbA1c levels by 0.54-0.68% more than placebo after 24 weeks.

Compared to sulphonylurea therapy, Edistride has shown at least equal efficacy: both drugs resulted in a reduction of HbA1c levels by 0.52% after 52 weeks.

What is the risk associated with Edistride - Dapagliflozin?

The most common side effect of Edistride (which may affect more than 1 in 10 people) is hypoglycaemia when given in combination with a sulphonylurea or insulin. For the full list of side effects and limitations of Edistride, see the package leaflet.

Why has Edistride - Dapagliflozin been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Edistride's benefits are greater than its risks and recommended that it be approved for use in the EU.

The CHMP concluded that Edistride has been shown to be effective in reducing blood glucose levels in patients with type 2 diabetes, whether used as monotherapy or in combination with other antidiabetic medicines with different mechanisms of action. Furthermore, other beneficial effects have been observed including weight loss and a decrease in blood pressure.

Frequently observed side effects, such as an increase in infections of the genital tract and, to a lesser extent, of the urinary tract (infection of the structures that carry urine), were related to the mode of action of the medicine and are considered manageable . A low but higher number of bladder, breast and prostate cancer cases was observed in patients treated with edistride than in the placebo group. However, no differences emerged between the groups when all types of cancer were considered; furthermore, preclinical studies examining the risk of cancer with Edistride did not encounter this risk. The committee recommended that further studies be carried out to investigate this issue further.

What measures are being taken to ensure the safe and effective use of Edistride - Dapagliflozin?

A risk management plan has been developed to ensure that Edistride is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Edistride, including the appropriate precautions to be followed by healthcare professionals and patients.