Commercialization suspended in the European market
What is Avandia?
Avandia is a medicine that contains the active substance rosiglitazone. It comes in tablet form (pink 2 mg, orange 4 mg or red-brown 8 mg).
What is Avandia used for?
Avandia is used in adult patients (especially if overweight) with type 2 diabetes (non-insulin-dependent diabetes. It can be used alone, in patients who are not suitable for treatment with metformin (an anti-diabetes medicine).
Avandia can be used in combination with metformin ("dual therapy"), in patients with type 2 diabetes for whom metformin alone is not sufficiently effective, or in combination with a sulfonylurea (another anti-diabetes medicine) if, vice versa, the patient cannot be treated with metformin.
AVANDIA can also be given in combination with metformin and a sulphonylurea ("triple therapy") in patients with insufficient disease control despite taking dual oral therapy.
The medicine can only be obtained with a prescription.
How is Avandia used?
Avandia can be taken both with and without food. The recommended starting dose is 4 mg per day in a single dose or in doses of 2 mg twice a day. If after eight weeks it is necessary to improve blood sugar control, the dose can be increased up to 8 mg per day. day, in a single dose, or up to 4 mg twice a day. However, caution is recommended in patients treated in parallel with a sulphonylurea, as there is a risk of fluid retention.
How does Avandia 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 ingredient in Avandia, rosiglitazone, makes cells (fat, muscle and liver) more sensitive to insulin and in this way the body makes better use of the insulin it produces. Consequently, the amount of glucose present in the blood is reduced and this allows for better control of type 2 diabetes. Avandia treatment of type 2 diabetes is added to diet and exercise.
How has Avandia been studied?
Avandia, given on its own, was studied compared to a placebo (a dummy treatment), metformin or glibenclamide (a sulphonylurea). It has also been studied in patients who are already being treated with another diabetes drug (metformin or a sulphonylurea) or with a combination of two diabetes drugs (metformin and a sulphonylurea). These studies were based on the level of a substance called glycosylated hemoglobin (HbA1c) in the blood which provides an "indication of how well the blood glucose is controlled."
What benefit has Avandia shown during the studies?
Avandia, given alone, has been shown to be more effective than placebo therapy in reducing "HbA1c. Use in combination with other anti-diabetic drugs has further reduced the level of HbA1c, indicating a consequent lowering of HbA1c levels." blood glucose.
What is the risk associated with Avandia?
The most common side effects of Avandia (one to ten patients out of a sample of 100) are
anemia (low number of red blood cells), hypercholesterolemia (high level of cholesterol in the blood), hypertriglyceridemia (high levels of triglycerides, a type of fat, in the blood), hyperlipemia (high levels of lipids, another type of fat, in the blood) , weight gain, increased appetite, cardiac ischaemia (reduced oxygen supply to the heart muscle), constipation, fractures, hypoglycemia (low glucose) and edema (swelling). For the full list of side effects reported with Avandia, see the Package Leaflet.
Avandia should not be used in patients who may be allergic to rosiglitazone or any of the other ingredients of the medicine or in patients with heart failure, liver problems, an "acute coronary syndrome" such as "unstable angina (a severe type of chest pain of varying intensity). ) or certain types of myocardial infarction or complications of diabetes (diabetic ketoacidosis or diabetic coma). The dose may also need to be adjusted if the patient takes medications such as gemfibrozil or rifampicin. For a complete list of these medications, see refer to the package leaflet.
Why has Avandia been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Avandia's benefits are greater than its risks in the treatment of type 2 diabetes mellitus and therefore recommended that Avandia be given a marketing authorization.
More information about Avandia
On 11 July 2000, the European Commission granted SmithKline Beecham plc a "Marketing Authorization" for Avandia, valid throughout the European Union. The marketing authorization was renewed on 11 July 2005. For the complete version of the AVANDIA EPAR click here.
Last update of this summary: 03-2008
The information on Avandia - rosiglitazone published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
