Commercialization suspended in the European market
What is that ?
Avandamet is a medicine containing two active substances, rosiglitazone and metformin hydrochloride.
It is available as tablets (yellow: 1 mg of rosiglitazone and 500 mg of metformin hydrochloride as well as 2 mg of rosiglitazone and 1000 mg of metformin hydrochloride; pale pink: 2 mg of rosiglitazone and 500 mg of metformin hydrochloride; pink: 4 mg of rosiglitazone and 1000 mg of metformin hydrochloride).
What is Avandamet used for?
Avandamet is used to treat type 2 diabetes (also called non-insulin dependent diabetes) particularly in overweight patients.
Avandamet is used in patients who are not sufficiently controlled on metformin (a medicine against diabetes) alone at the maximum possible dose ("double therapy").
Avandamet can also be used in combination with a sulphonylurea (another type of diabetes medicine) in patients who are not satisfactorily controlled with metformin and a sulphonylurea at the maximum possible dose ("triple therapy").
The medicine can only be obtained with a prescription.
How is Avandamet used?
The recommended starting dose is 4 mg / day of rosiglitazone plus 2000 mg / day of metformin hydrochloride, divided into 2 doses per day (2 tablets of Avandamet 1 mg / 500 mg or 1 tablet of Avandamet 2 mg / 1000 mg). The dose can be increased up to 8 mg of rosiglitazone per day after eight weeks if better blood glucose control is needed, but caution should be exercised with patients also taking a sulphonylurea due to the risk of fluid retention. The dose is adjusted to obtain the best possible control. The maximum recommended daily dose is 8 mg / 2000 mg. The dose of rosiglitazone can be added to metformin and can be adapted before the patient passes to Avandamet.
In triple therapy, when treatment is started in patients already taking metformin and a sulphonylurea, Avandamet is given so that the patient receives 4 mg / day of rosiglitazone and the same dose as before metformin. If the patient is already undergoing triple therapy, Avandamet is administered in such a way as to give the same doses as before of rosiglitazone and metformin. Taking Avandamet during or immediately after meals may reduce stomach problems caused by metformin.
How does Avandamet work?
Type 2 diabetes is a disease due to the fact that the pancreas does not produce enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. Avandamet contains two active ingredients that each perform a different action:
- rosiglitazone makes the cells (of adipose tissue, muscles and liver) more sensitive to insulin, so that the body makes better use of the insulin it produces.
- Metformin basically inhibits glucose production and reduces its absorption in the intestine.
The result of the combined action of the two active ingredients is a reduction in blood glucose, which helps to control type 2 diabetes. Treatment of type 2 diabetes with Avandamet is complementary to diet and exercise.
What studies have been carried out on Avandamet?
Rosiglitazone alone has been approved by the European Union (EU) since 2000 under the name of Avandia, to be used together with metformin in the treatment of type 2 diabetes in patients in whom metformin alone does not give sufficient control. Studies conducted on Avandia taken on
combination with metformin but in separate tablets were used to support the use of Avandamet for the same indications. Another study compared the results obtained by administering both rosiglitazone and a placebo (a dummy treatment) together with metformin. In triple therapy, one study analyzed the effect of adding rosiglitazone to a sulfonylurea (glibenclamide) and metformin to the treatment of 1202 patients whose blood glucose levels were not sufficiently controlled.
These studies measured the concentration in the blood of a substance called glycosylated hemoglobin (HbA1c) which gives an indication of the efficacy of blood glucose control.
What benefit has Avandamet shown during the studies?
Avandamet was more effective than metformin alone and placebo in reducing HbA1c.
The addition of rosiglitazone to treatment with metformin and a sulphonylurea produces a further, but slight, reduction in HbA1c levels.
What is the risk associated with Avandamet?
The most common side effects with Avandamet (seen in more than 1 patient in 10) are hypoglycaemia (low blood sugar), edema (swelling) and gastrointestinal symptoms (stomach ache). For the full list of all side effects reported with Avandamet, see the Package Leaflet.
Avandamet should not be used in patients allergic to rosiglitazone, metformin or other components of the medicine, or patients with heart failure, an "acute coronary syndrome" such as unstable angina (a severe type of variable intensity chest pain) or certain types of myocardial infarction, diseases that could affect the supply of oxygen in the tissues (such as heart or lung problems, shock or recent myocardial attack) or liver or kidney problems, severe alcohol intoxication (excessive alcohol consumption), alcoholism or complications of diabetes (diabetic ketoacidosis or diabetic coma).
The dose of Avandamet may need to be adjusted if the patient takes other medicines at the same time (eg gemfibrozil or rifampicin). For the complete list, consult the
brochure.
Why has Avandamet been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of AVANDAMET outweigh its risks in the treatment of type 2 diabetes and therefore recommended the granting of the marketing authorization for Avandamet.
More information on Avandamet
On 20 October 2003, the European Commission granted the marketing authorization for Avandamet, valid throughout the EU, to SmithKline Beecham plc. The marketing authorization was renewed on 20 October 2008.
The full EPAR for Avandamet can be found here.
Last update of this summary: 08-2008
