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Added benefit of the fixed combination of dapagliflozin and metformin is not proven
Date:5/15/2014

The fixed combination of the drugs dapagliflozin and metformin (trade name: Xigduo) has been approved since January 2014 for adults with type 2 diabetes in whom diet and exercise do not provide adequate glycaemic control. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) now examined whether this new drug combination offers an added benefit over the appropriate comparator therapy. No such added benefit can be derived from the dossier, however, because the drug manufacturer did not present any suitable data for any of the possible therapeutic indications.

Monotherapy or combination therapy possible

Dapagliflozin is approved both alone and in combination with other blood-glucose lowering drugs, including insulin. IQWiG already published an early benefit assessment of dapagliflozin as monotherapy in March 2013. The Institute concluded in this assessment that an added benefit was not proven because of a lack of suitable data.

The fixed combination with metformin is an option for patients who are already taking dapagliflozin and metformin as separate tablets or for patients or who do not benefit sufficiently from the commonly used drug metformin. It can also be used together with other blood-glucose lowering drugs, including insulin, if metformin and these drugs are insufficient.

G-BA specified appropriate comparator therapy

The Federal Joint Committee (G-BA) specified a different appropriate comparator therapy for each of three different indications: For the fixed combination alone, this appropriate comparator therapy was a sulfonylurea (glibenclamide or glimepiride) plus metformin. When the fixed combination is administered together with insulin or other blood-glucose lowering drugs, the appropriate comparator therapy was human insulin plus metformin. The G-BA additionally co
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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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