alogliptin / pioglitazone
This is a summary of the European public assessment report (EPAR) for Incresync. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Incresync.
For practical information about using Incresync, patients should read the package leaflet or contact their doctor or pharmacist.
What is Incresync and what is it used for?
Incresync is a diabetes medicine containing the active substances alogliptin and pioglitazone. It is used as an addition to diet and exercise in adults with type 2 diabetes to improve the control of blood glucose (sugar) levels:
•in patients who are not satisfactorily controlled with pioglitazone alone, and who cannot be treated with metformin (another diabetes medicine);
•together with metformin, in patients who are not satisfactorily controlled with a combination of pioglitazone and metformin.
Incresync can also be used as a replacement tablet (supplying both alogliptin and pioglitazone) in patients who are already being treated with alogliptin and pioglitazone given separately.
How is Incresync used?
Incresync is available as tablets (12.5 or 25 mg alogliptin and 30 mg pioglitazone; 12.5 or 25 mg alogliptin and 45 mg pioglitazone) and can only be obtained with a prescription. It is taken by mouth once daily. The choice of tablet strength to start with depends on the patient’s current treatment. If patients were previously taking pioglitazone alone, the strength of Incresync that provides the same dose of pioglitazone should be used. If patients are also taking metformin, lower doses of metformin or pioglitazone may need to be given to reduce the risk of hypoglycaemia (low blood sugar levels). If patients were previously taking pioglitazone and alogliptin separately, Incresync should be used in a
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strength that continues to provide the same doses. The dose should be lowered in patients with moderately reduced kidney function. For further information, see the summary of product characteristics (also part of the EPAR).
How does Incresync work?
Alogliptin is a
Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. Pioglitazone is authorised in the EU as Actos and associated names.
As a result of the action of both active substances, blood glucose levels are reduced and this helps to control
What benefits of Incresync have been shown in studies?
Incresync has been studied in two main studies involving 1,296 patients with
Both studies showed that the combination of active substances in Incresync could produce a small but clinically relevant improvement in HbA1c. When added to pioglitazone, the improvement was a fall of 0.47% at a dose of alogliptin of 12.5 mg, and 0.61% for alogliptin 25 mg. Incresync was at least as effective as pioglitazone and metformin in reducing HbA1c.
What are the risks associated with Incresync?
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 (feeling sick), dyspepsia (heartburn), abdominal pain (tummy ache), pruritus (itching), myalgia (muscle pain), peripheral oedema (swelling in arms and legs) and weight gain. For the full list of all side effects reported with Incresync, see the package leaflet.
Incresync must not be used in patients who are hypersensitive (allergic) to the active substances or any of the ingredients or who have had serious allergic reactions to any
Why is Incresync approved?
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Incresync’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that adding alogliptin to existing treatment with pioglitazone with or without metformin had shown to produce modest but clinically relevant improvements in HbA1c. The CHMP therefore considered that the combination of alogliptin and pioglitazone in Incresync is of benefit to patients. Regarding safety, Incresync’s safety profile was consistent with that seen with the individual components.
What measures are being taken to ensure the safe and effective use of Incresync?
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 educational materials for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Other information about Incresync
The European Commission granted a marketing authorisation valid throughout the European Union for Incresync on 19 September 2013.
The full EPAR for Incresync can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Incresync, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in