What is Xiliarx?
Xiliarx is a medicine that contains the active substance vildagliptin. It is available as light yellow round tablets (50 mg).
This medicine is identical to Galvus, already authorized in the European Union (EU). The company that makes Galvus has agreed that its scientific data will be used for Xiliarx.
What is Xiliarx used for?
Xiliarx is used 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 this other medicine taken alone. Xiliarx can be used in combination with metformin, a thiazolidinedione or a sulphonylurea, but in patients who cannot take metformin it is only combined with a sulphonylurea.
The medicine can only be obtained with a prescription.
How is Xiliarx used?
In adult patients, the recommended dose of Xiliarx is:
- when 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 Xiliarx should not exceed two tablets (100 mg). Xiliarx can be taken with or without food.
Xiliarx is not recommended for use in patients with moderate or severe kidney problems, including patients on hemodialysis (a blood clearance technique) with end-stage renal disease. The use of Xiliarx is not recommended in patients with liver problems. The medicine should be used with caution in patients over 75 years of age.
How does Xiliarx work?
Type 2 diabetes 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 Xiliarx, vildagliptin, is a dipeptidylpeptidase 4 (DPP-4) inhibitor. It works by inhibiting the breakdown of 'incretin' hormones in the body. These hormones, 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 if blood glucose concentration is low. Vildagliptin also reduces the amount of glucose produced by the liver by increasing insulin levels and reducing the levels of the glucagon hormone. Together, these processes reduce blood glucose and contribute to the control of type 2 diabetes.
How has Xiliarx been studied?
The effects of Xiliarx were first tested in experimental models before being studied in humans.
Furthermore, Xiliarx has been tested in seven main studies involving more than 4, 000 patients with type 2 diabetes and insufficient blood glucose control.
Three of these studies considered the effects of Xiliarx taken alone 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 Xiliarx, at a dose of 50 or 100 mg a day for 24 weeks, with those of placebo, used in addition to the existing 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 Xiliarx shown during the studies?
In all the studies Xiliarx reduced the level of HbA1c. Used alone, the medicine resulted in a reduction in HbA1c levels of about 1% from a starting level of about 8% after 24 weeks, but was less effective than metformin or rosiglitazone.
In adjunctive therapy to existing treatment for type 2 diabetes, Xiliarx 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 existing 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 Xiliarx to existing insulin therapy resulted in a greater reduction in HbA1c levels compared to placebo, the extent of this effect was too small to be considered significant for patients.
During the evaluation of the medicine the company withdrew the authorization application for the use of Xiliarx alone and in addition to insulin therapy.
What is the risk associated with Xiliarx?
The most common side effect of Xiliarx (detected in a number between 1 and 10 patients in 100) is dizziness. For the full list of all side effects reported with Xiliarx, see the Package Leaflet.
Xiliarx should not be used in people who may be hypersensitive (allergic) to vildagliptin or any of the other ingredients. Use in heart disease patients should be limited to those with mild illnesses.
Because vildagliptin has been associated with liver problems, patients must have liver tests before taking Xiliarx and at regular intervals during treatment.
Why has Xiliarx been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Xiliarx'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 recommended that Xiliarx be given marketing authorization.
More information on Xiliarx:
On 19 November 2008, the European Commission granted a marketing authorization for Xiliarx, valid throughout the European Union, to Novartis Europharm Limited.
The full EPAR for Xiliarx can be found here.
Last update of this summary: 10-2008.
