What is Actos?
Actos is a medicine that contains the active substance pioglitazone. The white, round tablets contain 15, 30 or 45 mg of pioglitazone.
What is Actos used for?
Actos is used to treat type 2 diabetes (also known as non-insulin-dependent diabetes).
• It can be used alone (monotherapy) in patients (especially if overweight) who cannot take metformin (an anti-diabetic medicine).
• It can be used together with another diabetes medicine (dual therapy). It can be added to metformin in patients (especially if overweight) who are not adequately controlled on metformin alone at the maximum tolerated dose; or it can be added to a sulphonylurea (another antidiabetic drug) when metformin is contraindicated and patients are not adequately controlled on sulphonylurea alone at the maximum tolerated dose.
• It can be used together with two other antidiabetic medicines, metformin and a sulphonylurea, as triple therapy in patients (especially if overweight) who are not sufficiently controlled with these two medicines.
• It can be used together with insulin in patients who are not sufficiently controlled on insulin alone and who cannot take metformin.
How is Actos used?
Actos is taken once a day, between meals or during meals. The dose is adjusted for best effect. The recommended starting dose is 15 mg or 30 mg once daily. The dose may need to be increased after one or two weeks to 45 mg once daily. In combination with metformin the current dose of metformin can be continued when starting treatment with Actos. In combination with a sulphonylurea or insulin, the current dose of sulphonylurea or insulin can be continued when starting treatment with Actos, provided that the patient does not suffer from hypoglycaemia (low blood glucose concentration), in which case the dose of sulphonylurea or insulin must be decreased.
How does Actos work?
Type 2 diabetes mellitus is a disease in which the pancreas does not produce enough insulin to control the level of glucose in the blood. The active substance in Actos, pioglitazone, makes cells more sensitive to insulin, so the body uses the insulin it produces better, the blood glucose is reduced and this serves to control type 2 diabetes.
How has Actos been studied?
Actos has been studied in clinical pharmacology studies and clinical trials. In total, approximately 7,000 patients received Actos. In these studies, Actos was compared with placebo (a dummy treatment) or other antidiabetic medicines (metformin, gliclazide). In some studies, Actos was also investigated in combination with other antidiabetic drugs (sulphonylureas, insulin, metformin). In triple therapy, the efficacy of Actos was studied in over 1400 patients receiving a combination of metformin and a sulfonylurea, to which Actos or placebo was added for up to 3.5 years.
These studies measured the concentration in the blood of a substance (glycosylated hemoglobin, HbA1c) which gives an "indication of how well the blood glucose is controlled."
What benefit has Actos shown during the studies?
Actos induced a drop in HbA1c, showing that blood glucose levels had decreased with dosages of 15 mg, 30 mg and 45 mg. Dosages below 15 mg have not been shown to be effective and dosages above 45 mg (once daily) have shown no additional benefit. Taken on its own, Actos was as effective as metformin and gliclazide. Taken in combination, Actos has been shown to improve the control of type 2 diabetes when added to ongoing therapy. At the end of the triple therapy study, the effect of adding Actos to ongoing treatment with metformin and a sulphonylurea was a 0.94% reduction in HbA1c levels, while the addition of placebo resulted in a reduction In a small study of the combination of Actos and insulin in 289 patients, patients who had Actos added to their insulin achieved a 0.69% reduction in HbA1c levels after 6 months, in comparison to 0.14% in the case of placebo.
What is the risk associated with Actos?
The most common side effects seen with Actos were vision disturbances, upper respiratory tract infections (colds), weight gain and hypoesthesia (decreased sensitivity to stimuli). For the complete list of all side effects reported with Actos, see the package leaflet.
Actos must not be used in patients who are hypersensitive (allergic) to pioglitazone or any of the other ingredients or in patients with liver problems, heart failure or diabetic ketoacidosis (high concentration of ketones [acids] in the blood).
Why has Actos been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Actos's benefits are greater than its risks for the treatment of type 2 diabetes. The Committee recommended that Actos be given a marketing authorization. The Committee decided that, on its own (ie when used alone), Actos should be considered an "alternative to standard treatment (metformin) in patients for whom metformin is contraindicated."
Other information about Actos:
On 13 October 2000, the European Commission released Takeda Europe R & D Center Limited
a "marketing authorization" for Actos, valid throughout the European Union.
The marketing authorization was renewed on 13 October 2005.
For the full version of Actos EPAR, click here.
Last update of this summary: 01-2007
The information on Actos - pioglitazone 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.
.jpg)
