Commercialization suspended in the European market
What is Avandia?
Avandia is a medicine that contains the active substance rosiglitazone. It comes in the form of tablets (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 on its own 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 sulphonylurea (another antidiabetes drug) 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 control of the disease, despite taking a dual oral therapy.
The medicine can only be obtained with a prescription.
How is Avandia used?
Avandia can be taken with or without food. The recommended starting dose is 4 mg daily in a single dose or in doses of 2 mg twice a day. If blood sugar control needs to be improved after eight weeks, the dose can be increased up to 8 mg a day, in a single dose, or up to 4 mg twice a day. However, caution is advised in patients treated in parallel with a sulphonylurea, as there is a risk of water 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 substance in Avandia, rosiglitazone, makes the cells (fat, muscle and liver) more sensitive to insulin and in this way the body uses the insulin it produces better. As a result, the amount of glucose in the blood is reduced and this allows for better control of type 2 diabetes. The treatment of type 2 diabetes with Avandia is added to diet and exercise.
What studies have been carried out on Avandia?
Avandia, administered alone, has been studied in comparison with a placebo drug (a dummy treatment), with metformin or glibenclamide (a sulphonylurea). It has also been studied in patients already being treated with another antidiabetes drug (metformin or a sulphonylurea) or with a combination of two antidiabetes drugs (metformin and a sulphonylurea). These studies were based on the level of a substance called glycosylated hemoglobin (HbA1c) in the blood that gives an indication of the effectiveness of blood glucose control.
What benefit has Avandia shown during the studies?
Avandia, administered alone, was more effective than placebo therapy to reduce HbA1c. Use in combination with other antidiabetes drugs has further reduced the level of HbA1c, which indicates a consequent lowering of blood glucose levels.
What is the risk associated with Avandia?
The most common side effects of Avandia (from one to ten patients on 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, one type of fat, in the blood), hyperlipemia (high levels of lipids, other types of fat, in the blood), weight gain, increased appetite, cardiac ischemia (reduced oxygen supply to the heart muscle), constipation, fractures, hypoglycemia (low glucose level) and edema (swelling). For the full list of all side effects reported with Avandia, see the Package Leaflet.
Avandia should not be used in patients who may be allergic to rosiglitazone or other components of the medicine or in patients with heart failure, liver problems, an "acute syndromecoronary" such as unstable angina (a severe type of variable intensity chest pain ) or certain types of myocardial infarctions or complications of diabetes (diabetic ketoacidosis or diabetic coma). It may also be necessary to adapt the dose if the patient takes drugs such as, for example, gemfibrozil or rifampicin. For the full list of these drugs, see 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 the marketing authorization for Avandia.
More information on Avandia
On 11 July 2000, the European Commission issued a marketing authorization valid for Avandia, valid throughout the European Union, to SmithKline Beecham plc. The marketing authorization was renewed on 11 July 2005. Click here for the full EPAR for AVANDIA.
Last update of this summary: 03-2008
