What is Galvus?
Galvus is a medicine containing the active substance vildagliptin, available as white to slightly yellowish, round tablets (50 mg).
What is Galvus used for?
Galvus is indicated for the treatment of type 2 diabetes mellitus (non-insulin-dependent diabetes). It is used in combination with another antidiabetic medicine (in "dual therapy"), when the patient's diabetes is not sufficiently controlled by the other drug alone. Galvus can be given in combination with metformin, a sulphonylurea or a thiazolidinedione, but in patients who cannot take metformin it is combined with a sulphonylurea only.
The medicine can only be obtained with a prescription.
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How is Galvus used?
In adult patients, the recommended daily dose of Galvus is:
• when combined with metformin or a thiazolidinedione, one tablet in the morning and one in the evening;
• when combined with a sulfonylurea, one tablet in the morning.
The daily dose of Galvus should not exceed two tablets (100 mg) and can be taken with or without meals. The use of Galvus is not recommended in patients with moderate or severe kidney problems or in patients on hemodialysis (a blood clearance technique) with end-stage renal disease. liver. The medicine should be used with caution in patients over 75 years of age.
How does Galvus work?
Type 2 diabetes mellitus is a disease in which the pancreas does not produce enough insulin to control the level of glucose (sugar) in the blood or where the body is unable to use insulin effectively. The active substance in Galvus, vildagliptin, is a dipeptidylpeptidase (DPP-4) inhibitor. It works by inhibiting the breakdown of "incretin" hormones in the body. Incretins, which are released into the blood after a meal, stimulate the pancreas to produce insulin.
By increasing the level of incretins in the blood, vildagliptin stimulates the pancreas to produce more insulin when the blood sugar level is high. Vildagliptin does not work when the blood glucose concentration is low. Vildagliptin also reduces the amount of sugar produced by the liver by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce the level of glucose in the blood and help control type 2 diabetes.
How has Galvus been studied?
The effects of Galvus were first tested in experimental models before being studied in humans.
Galvus has also been studied in seven main studies involving more than 4,000 patients with type 2 diabetes mellitus and poor blood glucose control.
Three of these studies looked at the effects of Galvus taken as monotherapy (alone) in 2,198 patients who had never been treated for diabetes, comparing it to placebo (a dummy treatment), metformin or rosiglitazone (a thiazolidinedione).
The other four studies compared the effects of Galvus, at a dose of 50 or 100 mg daily for 24 weeks, with those of placebo, in combination with previous treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients). , glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients). In all of the studies, the main measure of effectiveness was the change in the concentration in the blood of a substance called 'glycosylated hemoglobin' (HbA1c), which gives an 'indication of how well the blood glucose is controlled.
What benefit has Galvus shown during the studies?
In all studies Galvus helped to reduce the level of HbA1c.
On its own it resulted in a reduction in HbA1c levels of approximately 1% from a starting level of 8% after 24 weeks, but was less effective than metformin or rosiglitazone.
As an add-on to previous treatment for type 2 diabetes, Galvus was more effective than placebo in lowering HbA1c levels. The daily dose of 100 mg, in combination with metformin and pioglitazone, was more effective than the 50 mg dose, resulting in a reduction in HbA1c levels of between 0.8% and 1.0%. In combination with glimepiride , both daily doses of 50 and 100 mg resulted in a reduction of approximately 0.6%. In contrast, more modest changes in HbA1c level, ranging from a decrease of 0 to 0, were observed in patients who added placebo to prior treatment. , 3% and an increase of 0.2%.
Although the addition of Galvus to previous insulin therapy resulted in a greater reduction in HbA1c levels than placebo, the extent of this reduction is such that it is not considered significant to the patient's health.
During the evaluation of the drug, the manufacturer withdrew the application for authorization for the use of Galvus as monotherapy and as an adjunct to insulin therapy.
What is the risk associated with Galvus?
The most common side effect reported with Galvus (seen in 1 to 10 patients out of a total of 100) is dizziness. For the full list of side effects reported with Galvus, see the Package Leaflet.
Galvus must not be used in people who may be hypersensitive (allergic) to vildagliptin or any of the other ingredients of the medicine. Use in patients with heart failure should be limited to those with mild heart failure.
Since vildagliptin appears to cause liver problems, patients should have liver tests before taking Galvus and at regular intervals during treatment.
Why has Galvus been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Galvus's benefits are greater than its risks for the treatment of type 2 diabetes mellitus when used as dual oral therapy in combination with metformin, a sulphonylurea or a thiazolidinedione. The Committee therefore recommended the granting of a marketing authorization for Galvus.
More information about Galvus
On 26 September / October 2007 the European Commission granted Novartis Europharm Limited a "Marketing Authorization" for Galvus, valid throughout the European Union.
For the full version of Galvus' EPAR, click here.
Last update of this summary: 02-2008
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