What is Qtern - Saxagliptin - Dapagliflozin and what is it used for?
Qtern is indicated in the treatment of adults with type 2 diabetes to improve the control of glucose (sugar) levels in the blood. Contains the active ingredients saxagliptin and dapagliflozin. Qtern is used in patients whose blood glucose levels are not adequately controlled with:
- metformin and one of the components of Qtern;
- a sulphonylurea and one of the components of Qtern;
- metformin, a sulphonylurea and one of the components of Qtern.
- Qtern can also be used as a substitute for saxagliptin and dapagliflozin taken as separate tablets.
How is Qtern - Saxagliptin - Dapagliflozin used?
Qtern is available as tablets (5 mg of saxagliptin and 10 mg of dapagliflozin) and can only be obtained with a prescription. The recommended dose is one tablet once a day. For more information, see the package leaflet.
How does Qtern - Saxagliptin - Dapagliflozin work?
Type 2 diabetes is a disease in which the pancreas does not produce enough insulin to control blood glucose levels or where the body is unable to use insulin effectively, which leads to increased levels of glucose in the blood.
Qtern contains two different active ingredients, each with a different mechanism of action:
- dapagliflozin works by blocking a protein in the kidneys, called type 2 sodium glucose transporter (SGLT2). Because blood is filtered by the kidneys, SGLT2 blocks the passage of glucose into the bloodstream into the urine. By blocking the action of SGLT2, dapagliflozin induces the elimination of more glucose through the kidneys and urine and, consequently, the reduction of the concentration of glucose in the blood. Dapagliflozin was authorized in the European Union (EU) as Forxiga in 2012;
- saxagliptin is a dipeptidyl-peptidase-4 inhibitor (DPP-4). It works by blocking the degradation of the incretins in the body. These hormones, which are released after a meal, stimulate the pancreas to produce insulin. By increasing the levels of incretins in the blood, saxagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Saxagliptin does not work when blood glucose is low. Saxagliptin also reduces the amount of glucose produced by the liver, increasing insulin levels and decreasing the levels of the glucagon hormone. Saxagliptin has been authorized in the EU since 2009 as Onglyza.
Thanks to the combined action of the two active ingredients, blood glucose is reduced and this helps to control type 2 diabetes.
What benefit has Qtern - Saxagliptin - Dapagliflozin shown during the studies?
The combination of dapagliflozin with saxagliptin (the same combination as Qtern) was evaluated in three main studies involving 1 169 adults with type 2 diabetes. The main measure of effectiveness was the change in the blood level (in the blood) of a substance called glycosylated hemoglobin (HbA1c), which provides an indication of the effectiveness of blood glucose control after 24 weeks of treatment.
The first study included patients whose blood glucose levels were not satisfactorily controlled on metformin alone. The results showed that when saxagliptin and dapagliflozin were taken together with metformin, HbA1c levels decreased by 1.5 percentage points after 24 weeks, compared with a 0.9 percentage point reduction with saxagliptin and metformin and 1.2 percentage points with dapagliflozin and metformin. At the beginning of the study, HbA1c levels averaged around 9%.
The second study included patients whose blood glucose levels were not satisfactorily controlled with the combination of metformin and dapagliflozin. The results showed that the addition of saxagliptin to treatment with dapagliflozin and metformin for 24 weeks reduced HbA1c levels by 0.5 percentage points, compared with a 0.2 percentage point reduction with the addition of placebo ( a dummy treatment) to treatment with dapagliflozin and metformin. At the beginning of the study, HbA1c levels were around 8%.
A further study, which included patients not controlled with metformin and saxagliptin, showed that the addition of dapagliflozin to treatment with saxagliptin and metformin for 24 weeks had reduced HbA1c levels by 0.8 percentage points, compared with a reduction of 0.1 percentage points with the addition of placebo to saxagliptin and metformin.
The company also provided the studies that had been used for the authorization of Forxiga and Onglyza, in which saxagliptin or dapagliflozin had been used together with a sulphonylurea.
What are the risks associated with Qtern - Saxagliptin - Dapagliflozin?
The most common side effects of Qtern (which may affect more than 1 in 10 people) are upper respiratory tract infection (such as nose and throat infections) and, when used in combination with a sulphonylurea, hypoglycemia (low blood glucose levels). For the full list of all side effects reported with Qtern, see the package leaflet.
Qtern should not be used in patients who have hypersensitivity (allergy) reactions to saxagliptin, dapagliflozin, to any of the other ingredients or who have had severe allergic reactions to a DPP-4 inhibitor or SGLT2 inhibitor.
Why has Qtern - Saxagliptin - Dapagliflozin been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Qtern's benefits are greater than its risks and recommended that it be approved for use in the EU.
The committee concluded that Qtern is effective when it is used to replace saxagliptin and dapagliflozin assumed as separate comprised. In addition, the CHMP considered Qtern effective for the control of blood glucose levels in patients in whom this control was not satisfactory with metformin administration with saxagliptin or dapagliflozin. Although both components of Qtern help to lower blood glucose levels, the effects of each can vary in different patients. The CHMP therefore considered that Qtern should only be used in patients who have already been treated with at least one of the components, to avoid overdose and so that the value of each component can be assessed individually.
Based on previous studies conducted on the individual components of Qtern used in conjunction with a sulphonylurea, the CHMP also approved the combination of Qtern with a sulphonylurea.
Regarding its safety profile, Qtern was well tolerated and presented the side effects characteristic of SGLT2 and DDP-4 inhibitors.
What measures are being taken to ensure the safe and effective use of Qtern - Saxagliptin - Dapagliflozin?
Recommendations and precautions to be followed by health professionals and patients for safe and effective use of Qtern have been added to the summary of product characteristics and the package leaflet.
More information on Qtern - Saxagliptin - Dapagliflozin
For the full version of EBR by Qtern, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Qtern, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
