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Author: Takeda Global Research and Development Centre (Europe) Ltd.


Long information

What is it?

Actos is a medicine that contains the active substance pioglitazone. It is available as white, round tablets (15, 30 and 45 mg).

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Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Actos is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight. It is used in addition to diet and exercise.

Actos is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.

Actos can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (?dual therapy?).

Actos can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (?triple therapy?).

Actos can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.

The medicine can only be obtained with a prescription.

How is it used?

The recommended starting dose of Actos is 15 or 30 mg once a day. This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed. Actos should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease). The tablets should be swallowed with water.

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How does it work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Actos, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.

How has it been studied?

Actos has been compared with placebo (a dummy treatment), metformin and gliclazide (a sulphonylurea) in a number of studies. Some studies also looked at combining Actos with a sulphonylurea, insulin or metformin, or with the combination of metformin and a sulphonylurea. Further studies also looked at long-term use of Actos. Almost 7,000 patients received Actos in all of the studies combined. The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.

What benefits has it shown during the studies?

Actos led to a decrease in the level of HbA1c, indicating that blood glucose levels had been reduced at doses of 15, 30 and 45 mg. Actos on its own was shown to be as effective as metformin and gliclazide. Actos also improved the glucose control obtained in type 2 diabetes when it was added to existing treatment with a sulphonylurea, insulin or metformin, or the combination of metformin and a sulphonylurea.

What is the risk associated?

The most common side effects with Actos (seen in between 1 and 10 patients in 100) are upper respiratory tract infection (colds), hypoaesthesia (reduced sense of touch), visual disturbance, bone fractures and increased weight. If Actos is used in combination with other antidiabetes medicines, other side effects may occur. For the full list of all side effects reported with Actos, see the package leaflet.

Actos should not be used in people who may be hypersensitive (allergic) to pioglitazone or any of the other ingredients. It must not be used in patients who have problems with their liver, patients who have had heart failure (when the heart does not work as well as it should) or patients with diabetic ketoacidosis (a complication of diabetes).

The doses of Actos may need to be adjusted when given with some other medicines such as gemfibrozil (used to lower cholesterol) or rifampicin (an antibiotic used to treat tuberculosis).

Why has it been approved?

The CHMP decided that Actos?s benefits are greater than its risks and recommended that it be given marketing authorisation.

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