What is Glyxambi - Empagliflozin - Linagliptin and what is it used for?
Glyxambi is a diabetes medicine indicated for the treatment of adults with type 2 diabetes to improve the control of glucose (sugar) levels in the blood. Contains two active ingredients, empagliflozin and linagliptin. Glyxambi is indicated in the following groups:
- patients whose blood glucose levels are not satisfactorily controlled by the combination of one of the active substances of Glyxambi (empagliflozin or linagliptin) with other diabetes medicines (metformin and / or a sulphonylurea);
- patients who are already taking empagliflozin and linagliptin as separate tablets.
How is Glyxambi - Empagliflozin - Linagliptin used?
Glyxambi is available as tablets (10 or 25 mg of empagliflozin with 5 mg of linagliptin) and can only be obtained with a prescription. The recommended dose is one tablet once a day. Patients switching from empagliflozin and linagliptin to Glyxambi should be given a dose of Glyxambi corresponding to the doses of empagliflozin and linagliptin contained in the separate tablets they previously took.
When Glyxambi is used in combination with insulin or a sulphonylurea, a lower dose may be needed to reduce the risk of hypoglycaemia (low blood sugar levels). Your doctor may need to reduce the dose of Glyxambi or discontinue use in patients with reduced kidney function. For more information, see the package leaflet.
How does Glyxambi - Empagliflozin - Linagliptin work?
Type 2 diabetes is a disease in which the body 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 an increase blood glucose levels. The two active ingredients present in Glyxambi act in different ways to reduce glucose levels:
- empagliflozin works by blocking a protein found in the kidneys, called the sodium-glucose type 2 transporter (SGLT2). Generally, since blood is filtered by the kidneys, SGLT2 blocks the passage of glucose into the blood in the urine. By blocking the action of SGLT2, empagliflozin induces the elimination of more glucose in the urine and, consequently, a reduction in the concentration of glucose in the blood. Empagliflozin was authorized in the European Union (EU) under the name of Jardiance in 2014.
- Linagliptin is a dipeptidyl-peptidase-4 inhibitor (DPP-4) and works by blocking the breakdown of incretins in the body. These hormones, which are released after a meal, stimulate the pancreas to produce insulin. By prolonging the action of incretins in the blood, linagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Linagliptin also reduces the amount of glucose produced by the liver by increasing insulin levels and reducing the levels of the glucagon hormone. Linagliptin has been authorized in the EU since 2011 under the name of Trajenta.
Together, these actions reduce blood glucose levels and help control type 2 diabetes.
What benefit has Glyxambi - Empagliflozin - Linagliptin shown during the studies?
The association of empagliflozin with linagliptin (the same as Glyxambi) was evaluated in three main studies involving 1, 221 adults with type 2 diabetes. The main measure of effectiveness was the change in the blood level 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 involved patients whose blood glucose levels were not satisfactorily controlled with metformin and linagliptin. These patients were given either empagliflozin or a placebo (a dummy treatment) in addition to the existing treatment. The results showed that the addition of empagliflozin to linagliptin and metformin caused a reduction in HbA1c levels of 0.7 to 0.8 percentage points after 24 weeks, compared to no reduction with the addition of placebo. At the beginning of the study, HbA1c levels were just below 8%.
The second study examined patients whose blood glucose levels were not satisfactorily controlled with the combination of metformin and empagliflozin. The addition of linagliptin to treatment with empagliflozin and metformin for 24 weeks reduced HbA1c levels from 7.8% to 7.2%, compared with a reduction from 7.9% to 7.7% with the addition of of placebo.
A further study compared a fixed-dose combination of empagliflozin and linagliptin (administered as an adjunct to metformin) with metformin treatment together with empagliflozin or linagliptin in patients whose blood glucose levels were not satisfactorily controlled by either metformin. HbA1c levels were around 8% before treatment. After 24 weeks of treatment the fixed-dose combination reduced HbA1c levels to below 6.9%, while with the use of empagliflozin and linagliptin alone it was around 7.3%.
What are the risks associated with Glyxambi - Empagliflozin - Linagliptin?
The most common side effects of Glyxambi (which may affect more than 7 people in 100) are urinary tract infections. The most serious side effects are ketoacidosis (high blood levels of acids called "ketoacids"), pancreatitis (inflammation of the pancreas), hypersensitivity (allergic reactions) and hypoglycemia (low blood sugar levels). For the full list of all side effects reported with Glyxambi, see the package leaflet.
Glyxambi should not be used in patients who have hypersensitivity (allergy) reactions to empagliflozin, linagliptin, to any of the other ingredients or who have had severe allergic reactions to a DPP-4 inhibitor or SGLT2 inhibitor. For the full list of limitations, see the package leaflet.
Why has Glyxambi - Empagliflozin - Linagliptin been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Glyxambi's benefits are greater than its risks and recommended that it be approved for use in the EU.
The Committee for Medicinal Products for Human Use considered that Glyxambi was effective in controlling blood glucose levels, an effect to which both components contribute. Regarding its safety profile, Glyxambi 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 Glyxambi - Empagliflozin - Linagliptin?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Glyxambi have been included in the summary of product characteristics and the package leaflet.
More information on Glyxambi - Empagliflozin - Linagliptin
For the full EPAR version of Glyxambi, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Glyxambi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
