What is Incresync and what is it used for - alogliptin and pioglitazone?
Incresync is an antidiabetic medicine containing the active substances alogliptin and pioglitazone. It is used as an adjunct to diet and exercise in adults with type 2 diabetes mellitus to improve the control of blood glucose (sugar) levels:
- in patients not adequately controlled on pioglitazone taken alone and for whom metformin (another antidiabetic medicine) is inappropriate;
- in combination with metformin, in patients inadequately controlled with a combination of pioglitazone and metformin.
Incresync can be used to replace separate alogliptin and pioglitazone tablets in patients already treated with this combination.
How is Incresync used - alogliptin and pioglitazone?
Incresync is available as tablets (12.5 or 25 mg of alogliptin and 30 mg of pioglitazone; 12.5 or 25 mg of alogliptin and 45 mg of pioglitazone) and can only be obtained with a prescription. It is taken by mouth once a day. The choice of starting dosage depends on the patient's previous treatment regimen. In patients previously treated with pioglitazone alone, Incresync should be taken at a strength that provides the same dose as pioglitazone. If patients are also being treated with metformin, lower doses of metformin or pioglitazone may need to be given to reduce the risk of hypoglycaemia (low blood sugar levels).If patients previously took pioglitazone and alogliptin separately, Incresync should be taken at a dosage that continues to deliver the same doses as previous therapy. It is necessary to reduce the dose in patients with moderate renal impairment. For more information, see the package leaflet.
How does Incresync - alogliptin and pioglitazone work?
Type 2 diabetes is a disease in which the insulin produced by the pancreas is insufficient to control the level of glucose in the blood or in which the body is unable to use insulin effectively. The active ingredients present In Incresync, alogliptin and pioglitazone act differently to correct this condition. Alogliptin is a dipeptidyl-peptidase-4 (DPP 4) inhibitor. It blocks the breakdown of “incretin” hormones in the body. These hormones are released after meals and stimulate the pancreas to produce insulin. By blocking the breakdown of incretins in the blood, alogliptin prolongs their action by stimulating the pancreas to produce more insulin when blood glucose levels are high. Alogliptin is not effective if blood glucose is low. Alogliptin also reduces the amount of glucose produced by the liver, increasing insulin levels and reducing levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help control type 2 diabetes. "EU with the name Vipidia. Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, allowing the body to make better use of the insulin it produces. Pioglitazone is authorized in the EU under the name Actos and associated names. Thanks to the combined action of the two active ingredients, blood glucose levels are reduced, and this serves to control type 2 diabetes.
What benefit has Incresync - alogliptin and pioglitazone shown during the studies?
Incresync has been studied in two main studies involving 1,296 patients with type 2 diabetes inadequately controlled by prior therapy. One of the studies compared the effects of alogliptin and placebo (a no-effect substance on the body) used as an adjunct to ongoing therapy with pioglitazone (the same combination as in Incresync), with or without metformin or another diabetes medicine. The other study compared the effects of adding alogliptin to ongoing treatment with pioglitazone and metformin, on the one hand, with increased pioglitazone doses, on the other. In both studies, the main measure of effectiveness was the change in the level of glycosylated hemoglobin (HbA1c), which is the percentage of hemoglobin in the blood that binds to glucose. HbA1c levels are an indicator of the effectiveness of glucose control. in the blood. HbA1c levels were measured after 26 weeks in the first study and 52 weeks in the second study. The two studies found that the combination of the active ingredients in Incresync produced a modest but clinically relevant improvement in HbA1c levels. In combination with pioglitazone, the improvement corresponded to a decrease of 0.47% with a 12.5 mg alogliptin dose and 0.61% with a 25 mg alogliptin dose. Incresync was at least as effective as pioglitazone and metformin in reducing HbA1c levels.
What is the risk associated with Incresync - alogliptin and pioglitazone?
The most common side effects with Incresync (which may affect up to 1 in 10 people) are upper respiratory tract infections (colds), sinusitis, headache, nausea, dyspepsia (heartburn), abdominal pain, itching, myalgia (muscle pain ), peripheral edema (swelling of the arms and legs) and weight gain. For the full list of side effects reported with Incresync, see the package leaflet. Incresync should not be used in patients who are hypersensitive (allergic) to the active substances or any of the other ingredients or who have had severe allergic reactions to a dipeptidylpeptidase inhibitor -4 (DPP 4). It should also not be used in patients who have or have suffered from heart failure or bladder cancer, with reduced liver function, diabetic ketoacidosis (a serious condition that can arise in diabetes) or with blood in urine of an unknown nature. See package leaflet for full list of restrictions.
Why has Incresync - alogliptin and pioglitazone been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Incresync's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted that the addition of alogliptin to ongoing therapy with pioglitazone with or without metformin had been shown to produce modest but clinically relevant improvements in HbA1c levels. The CHMP therefore considered that the combination of alogliptin and pioglitazone in Incresync is of benefit to patients. Regarding safety, the safety profile of Incresync is consistent with that observed for the individual components of the medicine.
What information is still awaited for Incresync - alogliptin and pioglitazone?
A risk management plan has been developed to ensure that Incresync is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Incresync, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Incresync will produce educational material for doctors prescribing the medicine, indicating the potential risk of heart failure and bladder cancer associated with pioglitazone-based treatments, the criteria for patient selection and the need to reassess therapy periodically and to stop it if patients no longer benefit from it.
More information about Incresync - alogliptin and pioglitazone
On 19 September 2013, the European Commission issued a "Marketing Authorization" for Incresync, valid throughout the European Union. For more information on Incresync therapy, read the package leaflet (included with the EPAR) or consult your doctor or the pharmacist. Last update of this summary: 08-2013.
The information on Incresync - alogliptin and 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.
