What is Galvus?

What is Galvus?
Galvus is a medicine that contains the active substance vildagliptin. It is available as tablets (50 mg).

What is Galvus used for?
Galvus is used to treat type-2 diabetes mellitus. It can be used in the following ways:

on its own (monotherapy) in patients whose diabetes is not sufficiently controlled by diet and exercise and who cannot take metformin;
together with metformin, a thiazolidinedione or a sulphonylurea (dual therapy) when the patient’s diabetes is insufficiently controlled by this other medicine taken alone, but it is only used in combination with a sulphonylurea in patients who cannot take metformin;
together with a sulphonylurea and metformin (triple therapy) in patients whose diabetes is not sufficiently controlled by these medicines plus diet and exercise;
together with insulin (with or without metformin) in patients whose diabetes is not sufficiently controlled by diet and exercise plus a stable dose of insulin.
The medicine can only be obtained with a prescription.

How is Galvus used?
In adults, the recommended dose of Galvus is:

one tablet in the morning and another in the evening (100 mg per day), when used alone, with metformin, with a thiazolidinedione, with metformin plus a sulphonylurea, or with insulin (with or without metformin);
one tablet in the morning (50 mg per day) when taken with a sulphonylurea. A lower dose of the sulphonylurea may also be considered to reduce the risk of hypoglycaemia (low blood glucose levels).
The daily dose should not exceed two tablets (100 mg). In patients with moderate or severe kidney problems, the recommended dose is 50 mg once daily.

How does Galvus work?
Type-2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. The active substance in Galvus, vildagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of ‘incretin’ hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Vildagliptin does not work when the blood glucose is low. Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type-2 diabetes.

How has Galvus been studied?
Galvus has been studied in eleven main studies involving a total of over 5,000 patients with type-2 diabetes and insufficient control of blood glucose levels.

Five of these studies looked at the effects of Galvus taken alone in a total of 3,644 patients, comparing it with placebo (a dummy treatment), metformin, rosiglitazone (a thiazolidinedione) or gliclazide (a sulphonylurea).

Four studies compared the effects of Galvus, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients).

A further study compared Galvus with placebo as an add-on treatment in 318 patients who were already taking metformin and glimepiride.

A further study compared Galvus with placebo as an add-on treatment in 449 patients who were already taking a stable dose of long-acting insulin. Some of the patients were also taking metformin.

In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.

What benefit has Galvus shown during the studies?
Galvus used on its own was effective at reducing levels of HbA1c, but was less effective than the comparator medicines. In the study comparing Galvus with metformin, significantly better results were seen with metformin: a reduction in HbA1c of 1.5 percentage points after 52 weeks compared with a reduction of around 1 percentage point in patients treated with Galvus.