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Added benefit of dapagliflozin is not proven
Date:6/6/2013

Dapagliflozin (trade name: Forxiga) has been approved in Germany since November 2012 for the treatment of type 2 diabetes mellitus. 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) examined whether this new drug offers an added benefit over the current standard therapy. No such added benefit can be derived from the dossier, however, because the drug manufacturer did not present any relevant data for any of the possible therapeutic indications of dapagliflozin.

Monotherapy or combination therapy possible

Dapagliflozin is approved both as monotherapy and in combination with other blood-glucose lowering drugs, including insulin. As monotherapy it is an option for patients who do not tolerate metformin. Dapagliflozin can also be used as combination therapy, either together with metformin or with sulfonylureas if either of these two drugs alone is insufficient to control blood sugar. Dapagliflozin can also be combined with insulin if the target blood sugar levels cannot be achieved with insulin alone. Other combinations with oral antidiabetics are possible, but these were not presented by the manufacturer in its dossier.

G-BA specified appropriate comparator therapy

The Federal Joint Committee (G-BA) specified a sulfonylurea (glibenclamide or glimepiride) as appropriate comparator therapy for the dapagliflozin monotherapy. The combination therapy of dapagliflozin and metformin was also to be compared with one of these two drugs (each supplemented with metformin). The combination of dapagliflozin with a sulfonylurea was to be tested against metformin in combination with one of the sulfonylureas glibenclamide or glimepiride. According to the G-BA's specifications, the combination of dapagliflozin and insulin was to be compared either with human insulin and metformin, or, if metformin was
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Contact: Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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