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

mmissioned IQWiG to also assess not only studies on glibenclamide and glimepiride, but also on glipizide in each case combined with metformin in the first research question.

Drugs were not used in compliance with their approval

The drug manufacturer presented results of a study that directly compared the fixed combination with glipizide plus metformin. In this study, however, which had already been the basis for its dossier on the monotherapy, the drugs were not used according to the specifications in the approval both in the intervention and in the control arm. It remained unclear whether the same effects would have been observed if the drugs had been administered in compliance with the Summary of Product Characteristics. At any rate, the study results cannot be interpreted with regard to the approval-compliant use.

Insulin therapy could not be optimized

For the second research question, in which the fixed combination was to be complemented with insulin, the manufacturer used three studies, which it had also already cited in the dossier on the monotherapy. However, their results could also not be used for assessing the added benefit. The main reason for this is that the insulin therapy could not be tailored sufficiently to the individual patient: Even though their current insulin therapy was insufficient, patients were neither supposed to change the insulin nor to adapt the dose. But to be able to draw conclusions about the added benefit, the fixed combination would have to be compared with other strategies for optimizing treatment, for example optimizing insulin use.

Not tailoring treatment to the individual patient does not meet the current standard of diabetological practice anyway. Instead, insulin therapy is optimized for the individual patient so that hyperglycaemia and hypoglycaemia do not occur in the first place. So in the study, insulin was not used in a way that would be necessary and appropr
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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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