What is Glyxambi - Empagliflozin - Linagliptin and what is it used for?
Glyxambi is a diabetes medicine used to treat adults with type 2 diabetes to improve the control of blood glucose (sugar) levels. It contains two active ingredients, empagliflozin and linagliptin. Glyxambi is indicated in the following groups:
- patients whose blood glucose levels are not satisfactorily controlled with the combination of one of the active substances of Glyxambi (empagliflozin or linagliptin) with other medicines for diabetes (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 strength of Glyxambi corresponding to the doses of empagliflozin and linagliptin contained in the separate tablets they were taking previously.
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 find it necessary to reduce the dose of Glyxambi or stop its use in patients. patients with impaired renal 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 in which the body cannot use insulin effectively, which leads to an increase blood glucose levels. The two active substances in Glyxambi work in different ways to reduce glucose levels:
- empagliflozin works by blocking a protein found in the kidneys called sodium-glucose type 2 cotransporter (SGLT2). Generally, because the blood is filtered by the kidneys, SGLT2 blocks the passage of glucose in the blood into the urine. By blocking the action of SGLT2, empagliflozin induces the elimination of more glucose in the urine and, consequently, the reduction of 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 (DPP-4) inhibitor 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. "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 hormone glucagon. 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 combination 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 how well the blood glucose is controlled after 24 weeks of treatment.
The first study involved patients whose blood glucose levels were not satisfactorily controlled on metformin and linagliptin. These patients were given empagliflozin or a placebo (a dummy treatment) in addition to the existing treatment. The results showed that adding empagliflozin to linagliptin and metformin caused a reduction in HbA1c levels of 0.7-0.8 percentage points after 24 weeks, compared with no reduction with the addition of placebo. At the start of the study, HbA1c levels were just below 8%.
The second study looked at patients whose blood glucose levels were not satisfactorily controlled with the combination of metformin and empagliflozin. Adding 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 placebo.
A further study compared a fixed-dose combination of empagliflozin and linagliptin (given in addition to metformin) with treatment with metformin together with empagliflozin or linagliptin in patients whose blood glucose levels were not satisfactorily controlled with 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 they were around 7.3%.
What are the risks associated with Glyxambi - Empagliflozin - Linagliptin?
The most common side effects with Glyxambi (which may affect more than 7 in 100 people) are urinary infections. The most serious side effects are ketoacidosis (high blood levels of acids called "ketoacids"), pancreatitis (inflammation of the pancreas), hypersensitivity (allergic reactions) and hypoglycaemia (low blood sugar levels). For the full list of side effects reported with Glyxambi, see the package leaflet.
Glyxambi should not be used in patients who have hypersensitivity (allergy) reactions to empagliflozin, linagliptin, 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 restrictions, 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 exhibited the characteristic side effects of SGLT2 and DDP-4 inhibitors.
What measures are being taken to ensure the safe and effective use of Glyxambi - Empagliflozin - Linagliptin?
The recommendations and precautions to be observed by healthcare professionals and patients for Glyxambi to be used safely and effectively have been set out in the summary of product characteristics and package leaflet.
More information about Glyxambi - Empagliflozin - Linagliptin
For the complete version of the Glyxambi EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Glyxambi therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The information on Glyxambi - Empagliflozin - Linagliptin published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
