What is Galvus?
Galvus is a drug containing the active substance vildagliptin, available in white to slightly yellowish, round-shaped tablets (50 mg).
What is Galvus used for?
Galvus is indicated in 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 taken alone. Galvus can be given in combination with metformin, a sulphonylurea or a thiazolidinedione, but in patients who cannot take metformin it is only combined with a sulphonylurea.
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:
• if combined with metformin or a thiazolidinedione, one tablet in the morning and one in the evening;
• if combined with a sulphonylurea, one tablet in the morning.
The daily dose of Galvus should not exceed two tablets (100 mg) and can be taken independently of 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. The use of Galvus is not recommended in patients with liver problems. 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 inhibitor (DPP-4). It works by inhibiting the degradation 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 incretin in the blood, vildagliptin stimulates the pancreas to produce more insulin when the glycemic rate is high. Vildagliptin does not work when 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 glucagon hormone. Together, these processes reduce blood glucose and contribute to the control of type 2 diabetes.
What studies have been carried out on Galvus?
The effects of Galvus were first tested in experimental models before being studied in humans.
In addition, Galvus has been studied in seven main studies involving more than 4, 000 patients with type 2 diabetes mellitus and insufficient blood glucose control.
Three of these studies considered the effects of Galvus taken alone (on its own) on 2 198 patients who had never been treated for diabetes, comparing it with 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 a day for 24 weeks, with those of placebo, combined with previous treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients). In all the studies, the main measure of effectiveness was the change in the blood concentration of a substance called "glycosylated hemoglobin" (HbA1c), which gives an indication of the effectiveness of blood glucose control.
What benefit has Galvus shown during the studies?
In all the studies Galvus has helped to reduce the level of HbA1c.
In monotherapy it resulted in a reduction in HbA1c levels of about 1% from a starting level of 8% after 24 weeks, but was less effective than metformin or rosiglitazone.
In adjunctive therapy to a previous treatment for type 2 diabetes, Galvus was more effective than placebo in reducing 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 50 and 100 mg daily doses induced a reduction of approximately 0.6%. In contrast, in patients who added placebo to previous treatment, more modest changes in the HbA1c level were observed, ranging from a decrease of 0.3% to an increase of 0.2%.
Although the addition of Galvus to previous insulin therapy has resulted in a greater reduction in HbA1c levels compared to placebo, the extent of this reduction is such that it is not considered significant for patient health.
During the evaluation of the drug the manufacturer withdrew the authorization application for the use of Galvus in monotherapy and in addition to insulin therapy.
What is the risk associated with Galvus?
The most common side effect reported with Galvus (seen in between 1 and 10 patients out of a total of 100) is dizziness. For the full list of all side effects reported with Galvus, see the Package Leaflet.
Galvus should not be used in people who may be hypersensitive (allergic) to vildagliptin or other ingredients in the medicine. Use in patients with heart failure should be limited to those with mild heart failure.
Because vildagliptin appears to be the cause of 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 in dual oral therapy in combination with metformin, a sulphonylurea or a thiazolidinedione. The Committee therefore recommended that Galvus be given marketing authorization.
More information on Galvus
On 26 September / October 2007, the European Commission granted a marketing authorization valid throughout the European Union for Galvus to Novartis Europharm Limited.
For the full EPAR of Galvus, click here.
Last update of this summary: 02-2008
