The primary aim of the SAFEGUARD project is to assess and further quantify and understand the cardio/cerebrovascular and pancreatic safety of blood glucose lowering agents, in particular the TZDs and the novel incretin-based drugs and amylin analogues in T2DM patients.
The SAFEGUARD Consortium is formed by a multidisciplinary group including diabetes experts, clinicians, pharmacologists, pharmacovigilance experts, statisticians and pharmacoepidemiologists; and will capitalize on knowledge generated in other EU funded projects to create a harmonized data platform. This platform will allow for the largest scale studies on T2DM drugs developed so far as well as for the implementation of new epidemiological studies.
Studies included in SAFEGUARD comprise:
- Systematic review of existing evidence from published clinical trials and observational studies and meta-analyses;
- Analysis of spontaneous adverse events reports in international pharmacovigilance databases
- Quantification of cardiovascular, cerebrovascular and pancreatic risk and identification of risk factors using healthcare databases from 6 countries.
- Mechanistic studies in humans for a better understanding the effect of T2DM drugs on cardiovascular, digestive and renal systems.
Results will aid defining the benefit-risk profile throughout the lifecycle of T2DM drugs.
Finally, with the integration of all information derived from the work in the project, a decision model will be developed to assist clinicians and patients in better treatment choices.