What is Tandemact?
Tandemact is a medicine that contains two active substances: pioglitazone and glimepiride. It is available as white, round tablets (30 mg of pioglitazone and 2 or 4 mg of glimepiride, or 45 mg of pioglitazone and 4 mg of glimepiride).
What is Tandemact used for?
Tandemact is used to treat adult patients with type 2 diabetes mellitus (also known as non-insulin dependent diabetes mellitus). It is indicated for the treatment of patients for whom metformin (a type of diabetes medicine) is contraindicated and who are already being treated with a combination of tablets containing the two active substances, pioglitazone and glimepiride.
The medicine can only be obtained with a prescription.
How is Tandemact used?
The usual dose of Tandemact is one tablet once a day to be taken immediately before or during the main meal. The tablets should be swallowed whole with some water. Patients who are taking pioglitazone in combination with another medicine of the same class of glimepiride (ie "another sulphonylurea) must change this" other sulphonylurea to glimepiride before switching to Tandemact. Patients who experience hypoglycaemia (low blood sugar levels) when taking Tandemact should reduce the dose of the medicine or go back to using separate tablets.
Tandemact must not be used in patients who have severe kidney problems or who have liver problems.
How does Tandemact work?
Type 2 diabetes is a disease where the pancreas does not produce enough insulin to control the level of glucose (sugar) in the blood, or where the body is unable to use insulin effectively. Tandemact contains two active ingredients, each of which has a different action. Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which allows the body to make better use of the insulin it produces. . Glimepiride is a sulphonylurea, which is a substance that stimulates the pancreas to produce more insulin. The result of the combined action of the two active ingredients is a reduction in the level of glucose present in the blood, which helps to control type 2 diabetes.
How has Tandemact been studied?
As pioglitazone has been authorized in the European Union (EU) since 2000 under the name Actos and glimepiride is already used in medicines authorized in the EU, the company presented data obtained in previous studies and drawn from the published literature. Actos is approved for use in combination with a sulphonylurea in type 2 diabetics who are not satisfactorily controlled on metformin alone. The company used three studies to support the use of Tandemact in the same indication.
These studies included 1 390 patients who added pioglitazone to their treatment with a sulphonylurea. In these studies, which lasted from four months to two years, the level of a substance called glycosylated hemoglobin (HbA1c) was measured in the blood, which gives an indication of how well the blood glucose is controlled.
In these studies, pioglitazone and sulphonylureas were given as separate tablets. The company provided evidence that the levels of the active substances in the blood of people taking Tandemact were the same as those of people taking separate tablets.
What benefit has Tandemact shown during the studies?
In all three studies, patients given a combination of pioglitazone and a sulphonylurea showed improvement in blood glucose control. Patients' HbA1c levels, which at the start of treatment (baseline) exceeded 7.5%, decreased by 1.22 - 1.64%. At least 64% of patients responded to therapy, i.e. their HbA1c levels decreased by at least 0.6% from baseline over the studies or were equal to or less than 6.1% at the end of the studies .
What is the risk associated with Tandemact?
The most common side effects with Tandemact (seen in 1 to 10 patients in 100) are weight gain, dizziness, flatulence (gas) and edema (localized swelling). For the full list of side effects reported with Tandemact, see the package leaflet.
Tandemact must not be used in patients who may be hypersensitive (allergic) to pioglitazone, glimepiride or any of the other ingredients, or to other sulphonylureas or sulfonamides. It must not be used by patients with heart failure, liver disorders or severe kidney problems. It should not be used by patients with type 1 diabetes (insulin-dependent diabetes), patients with complications of diabetes (diabetic ketoacidosis or diabetic coma), or women who are pregnant or breastfeeding.
The doses of Tandemact may need to be changed if the drug is taken with other medicines. The full list of these medicines can be found in the Summary of Product Characteristics, which is also part of the EPAR.
Why has Tandemact been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the efficacy of pioglitazone and glimepiride in type 2 diabetes has been demonstrated and that Tandemact simplifies treatment and improves patients' ability to stick to their treatment when a combination of the two active substances. Has decided that Tandemact's benefits are greater than its risks for the treatment of type 2 diabetes in patients who cannot tolerate metformin or for whom metformin is contraindicated and who are already being treated with a combination of pioglitazone and glimepiride and recommended the granting of marketing authorization for
Learn more about Tandemact
On January 8, 2007, the European Commission granted Takeda Global Research and Development Center (Europe) Ltd a "Marketing Authorization" for Tandemact, valid throughout the European Union.
For the full version of the Tandemact EPAR, click here.
Last update of this summary: 04-2008
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