Empagliflozin (trade name Jardiance) has been approved since May 2014 for adults with type 2 diabetes mellitus in whom diet and exercise alone do not provide adequate glycaemic control. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether the drug offers an added benefit over the appropriate comparator therapies in these patient groups. 

According to the findings, such an added benefit is not proven: For four of five research questions, the manufacturer presented no relevant data in its dossier. For the fifth research question, on the one hand, it presented data from a direct comparison, in which empagliflozin was initially administered at a larger dose than recommended by the approval. Moreover, the study arms not only differed in the drug combination, but also in the therapeutic strategy. On the other hand, the manufacturer conducted two indirect comparisons based on an incomplete study pool and on studies that were unsuitable for the assessment.

Empagliflozin is approved as monotherapy for patients who do not tolerate metformin. It is approved as add-on therapy in combination with other blood-glucose lowering drugs including insulin when these, together with diet and exercise, do not provide adequate glycaemic control.

The Federal Joint Committee (G-BA) specified different appropriate comparator therapies for the subindications, resulting in a total of five comparisons: empagliflozin as monotherapy versus a sulfonylurea (A), in combination with metformin versus metformin and a sulfonylurea (B1), in combination with another blood-glucose lowering drug also in comparison with metformin and sulfonylurea (B2), in combination with at least two other blood-glucose lowering drugs in comparison with metformin and human insulin (C) and in combination with insulin also in comparison with metformin plus human insulin (D).

The manufacturer postulated an added benefit, which was partly considerable and partly non-quantifiable, for the research questions A, B2, C and D, but submitted no relevant data. An added benefit of empagliflozin versus the appropriate comparator therapies is therefore not proven in these cases.

For more details, go to: https://www.iqwig.de/en/press/press-releases/press-releases/empagliflozin-in-type-2-diabetes-added-benefit-not-proven.6422.html