What is Incresync and what is it used for - alogliptin and pioglitazone?
Incresync is a diabetes 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 blood glucose (sugar) levels:
- in patients not adequately controlled with pioglitazone taken on its own and for whom metformin (another antidiabetes 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 - alogliptin and pioglitazone used?
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 the initial dosage depends on the previous therapeutic regimen of the patient. In patients previously treated with pioglitazone alone, Incresync should be taken at a dose that provides the same dose of pioglitazone. If patients are also on metformin, lower doses of metformin or pioglitazone may be needed to reduce the risk of hypoglycaemia (low blood sugar levels). If patients first took pioglitazone and alogliptin separately, Incresync should be taken at a dose that continues to provide the same doses as the previous therapy. Dose reduction is necessary 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 not sufficient to control the level of glucose in the blood or where the body is unable to use insulin effectively. The active substances present in Incresync, alogliptin and pioglitazone, act differently to correct this condition. Alogliptin is a dipeptidyl-peptidase-4 inhibitor (DPP 4). It blocks the degradation 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 stimulating action on 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 the levels of the glucagon hormone. Together, these processes reduce blood glucose levels and help control type 2 diabetes. Alogliptin is licensed in the EU under the name Vipidia. Pioglitazone makes the cells (fat, muscle and liver) more sensitive to insulin, allowing the body to better use 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 not adequately controlled by previous therapy. One of the studies compared the effects of alogliptin and placebo (an ineffective substance on the body) used in addition to ongoing therapy with pioglitazone (the same combination found in Incresync), with or without metformin or another antidiabetic medicine . The other study compared the effects of adding alogliptin to ongoing treatment with pioglitazone and metformin, on the one hand, with an increase in the dose of pioglitazone, 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 blood glucose control. HbA1c levels were measured after 26 weeks in the first study and 52 weeks in the second study. The two studies showed 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 dose of alogliptin of 12.5 mg and 0.61% with a dose of alogliptin of 25 mg. 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 of 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 all 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 to any of the other ingredients or who have had severe allergic reactions to a dipeptidylpeptidase-4 inhibitor (DPP 4). It must also not be used in patients who suffer 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 the presence of blood in the urine of an unconfirmed nature. For the full list of limitations, see the package leaflet.
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 an 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 offers benefits to patients. As for 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 included in the summary of product characteristics and the 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 information material for the doctors who prescribe the medicine, indicating the potential risk of heart failure and bladder cancer associated with pioglitazone-based treatments, criteria for patient selection and the need to re-evaluate the therapy periodically and to stop it if patients no longer benefit from it.
Other information on 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 about treatment with Incresync, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 08-2013.
