Victoza - liraglutide
What is Victoza?
Victoza is a solution for injection that contains the active substance liraglutide, available in pre-filled pens (6 mg / ml).
What is Victoza used for?
Victoza is used for adult patients with type 2 diabetes (non-insulin-dependent diabetes) to control the level of glucose (sugar) in the blood. Victoza is used in combination with:
• metformin or a sulphonylurea (antidiabetic medicines), in patients with insufficient glycemic control despite the maximum tolerated dose of metformin or sulphonylurea alone;
• metformin and a sulphonylurea or metformin and a thiazolidinedione (another group of antidiabetic medicines) in patients with insufficient glycemic control despite two-drug therapy.
The medicine can only be obtained with a prescription
How is Victoza used?
Victoza is given once a day and can be injected subcutaneously (under the skin) in the abdomen, thigh or upper arm. The medicine can be taken at any time, regardless of meals, preferably at the same time. everyday.
The starting dose of Victoza is 0.6 mg. After at least one week, the dose should be increased to 1.2 mg. For some patients, the dose may still be increased to 1.8 mg after an additional week to achieve better control of the blood glucose level.
In cases where Victoza is added to existing metformin or a thiazolidinedione therapy, there is no need to vary the doses of these medicinal products. However, if Victoza is added to a treatment with a sulfonylurea, it will be up to the doctor to decide whether or not to lower the dose of the sulfonylurea to reduce the risk of hypoglycaemia (low blood sugar).
How does Victoza 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 when the body is unable to use insulin effectively. The active substance in Victoza, liraglutide, is an 'incretin mimetic': it works in a similar way to incretins (hormones produced in the intestine) by increasing the amount of insulin released by the pancreas in response to food. This helps to control food. blood glucose levels.
How has Victoza been studied?
The effects of Victoza were first tested in experimental models before being studied in humans.
The medicine has been studied in five main studies involving 3 978 adults with type 2 diabetes, namely:
• a 'monotherapy' study comparing Victoza, given alone, with glimepiride (a sulphonylurea);
• two 'dual therapy' studies comparing Victoza in combination with metformin or Victoza in combination with glimepiride with metformin or glimepiride taken with a placebo (a dummy treatment);
• two 'triple therapy' studies comparing Victoza in combination with metformin and glimepiride or rosiglitazone (a thiazolidinedione), with treatments that included a placebo or another diabetes medicine instead of Victoza.
The main measure of effectiveness was the change in the amount of a substance in the blood called glycosylated hemoglobin (HbA1c) after six months or a year. "HbA1c offers an indication of how well the blood glucose is controlled."
What benefit has Victoza shown during the studies?
Combinations including Victoza were shown to be more effective in controlling blood glucose than combinations where the medicine did not appear. Dual therapies, containing Victoza and metformin or a sulphonylurea, allowed reductions in HbA1c of approximately 1%, while no reduction was recorded in the absence of Victoza. Three-drug therapies including metformin and a sulphonylurea or a thiazolidinedione a reduction of 1.3-1.5% compared to a reduction of 0.5% or less without Victoza allowed. In monotherapy, a greater reduction in HbA1c was also found with Victoza than with glimepiride. However, the study was not sufficient to support the use of Victoza alone.
What is the risk associated with Victoza?
The most common side effects seen with Victoza, used in combination with other antidiabetic medicines (in more than 1 in 10 patients) are hypoglycaemia (low blood glucose), headache, nausea and diarrhea. For the full list of side effects reported with Victoza, see the Package Leaflet.
Victoza must not be used in people who may be hypersensitive (allergic) to liraglutide or any of the other ingredients.
Why has Victoza been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Victoza's benefits are greater than its risks for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in dual therapy, in combination with metformin or a sulphonylurea. , i.e. in three-drug therapy in combination with metformin and a sulphonylurea or a thiazolidinedione. The Committee therefore recommended the granting of a marketing authorization for Victoza.
Other information about Victoza:
On 30 June 2009, the European Commission granted Novo Nordisk A / S a "Marketing Authorization" for Victoza, valid throughout the European Union.
For the full version of Victoza's EPAR, click here.
Last update of this summary: 05-2009.
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