Xiliarx

Xiliarx can only be obtained with a prescription and is available as 50-mg tablets. The recommended dose of Xiliarx 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).

In patients with moderate or severe kidney problems, the recommended dose is 50 mg once daily.

Because vildagliptin has been associated with liver problems, the doctor should carry out tests to check the patient’s liver function before treatment with Xiliarx and at regular intervals during treatment.

For more information about using Xiliarx, see the package leaflet or contact your doctor or pharmacist.

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Xiliarx, 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 blocking the breakdown of incretin hormones in the blood, vildagliptin prolongs their action, stimulating 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.

Xiliarx on its own or as an add-on treatment has been studied in 11 main studies involving a total of over 6,000 patients with type 2 diabetes and insufficient control of blood glucose levels. 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.

Xiliarx was effective at reducing levels of HbA1c but was less effective than metformin, rosiglitazone (a thiazolidinedione) or gliclazide (a sulphonylurea). In a study comparing Xiliarx 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 Xiliarx.

When used as an add-on to metformin and to pioglitazone (a thiazolidinedione), Xiliarx reduced HbA1c levels by 0.8 to 1.0 percentage points. When used with glimepiride (a sulphonylurea), Xiliarx caused a reduction of around 0.6 percentage points. In contrast, patients adding placebo to their existing treatment showed smaller changes in HbA1c levels, ranging from a fall of 0.3 to a rise of 0.2 percentage points.

As an add-on to metformin plus glimepiride, Xiliarx reduced HbA1c levels by 1 percentage point, compared with a reduction of 0.3 percentage points in patients taking placebo.

Finally, when used as an add-on to insulin treatment, Xiliarx caused a greater reduction in HbA1c levels than adding placebo, but the size of this effect in one study was small, possibly due to the fact that the study included long-term patients who were less likely to show improvement. However, in another study, the size of this effect was significant. Patients taking Xiliarx in addition to insulin, with or without metformin, had a reduction in HbA1c levels of 0.77 percentage points, compared with 0.05 percentage points in patients taking placebo in addition to insulin.

The most common side effect with Xiliarx (which may affect up to 1 in 10 people) is dizziness. For the full list of all side effects reported with the medicine, including side effects occurring when it is taken with other diabetes medicines, see the package leaflet.

For the full list of restrictions, see the package leaflet.

Studies have shown Xiliarx to be effective as add-on to metformin, a thiazolidinedione or a sulphonylurea (dual therapy), a sulphonylurea and metformin (triple therapy) or insulin with or without metformin. Xiliarx on its own has also been shown to be effective in reducing blood glucose but less so than metformin. The medicine should therefore be used only in patients for whom metformin is inappropriate either because of side effects occurring with metformin or because they have a condition that makes metformin unsuitable for them. The side effects of Xiliarx were mostly mild and resolved over time.

The European Medicines Agency decided that Xiliarx’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xiliarx have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of the medicine are continuously monitored. Suspected side effects reported with the medicine are carefully evaluated and any necessary action taken to protect patients.

Xiliarx received a marketing authorisation valid throughout the EU on 19 November 2008.