Northerner
Admin (Retired)
- Relationship to Diabetes
- Type 1
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.
http://medicalxpress.com/news/2014-11-empagliflozin-diabetes-added-benefit-proven.html
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.
http://medicalxpress.com/news/2014-11-empagliflozin-diabetes-added-benefit-proven.html