National Research Project
The European project SAFEGUARD aims to assess and further quantify and understand the cardio/cerebrovascular and pancreatic safety of blood glucose lowering agents, in particular the thiazolidinedones (TZDs) and the novel incretin-based drugs and amylin analogues in Type 2 Diabetes Mellitus (T2DM) patients. For this purpose the project includes the analysis of anonymised and aggregated data from more than 1.7 million patients in Europe and the US, the systematic review of available evidence from published observational studies and clinical trials, and implementation of state-of-the-art mechanistic studies.
SAFEGUARD addresses a specific question of the European Commission included in the topic “Responding to EU policy needs” within the 7th Framework Programme Cooperation Work Programme Health 2011. This topic contributes to the support and follow-up of the policies and requests from the Pharmacovigilance Working Party at the European Medicines Agency with regards all member states.