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EU Grants the Largest Project for the Safety Evaluation of Drugs Used for the Treatment of Diabetes
posted 2012.10.24

Almost 2 million patients with Type 2 Diabetes Mellitus (T2DM) will be evaluated with the objective of studying the side effects of T2DM drugs.

The three-year European project SAFEGUARD, funded by the European Commission, aims to assess and further quantify and understand the effects of all existing oral blood glucose lowering agents in humans by means of the analysis of anonymised and aggregated data from more than 1.7 million diabetes patients in Europe and the US, the revision of published observational studies and clinical trials, and the 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.

Lead scientist Prof. Miriam Sturkenboom, of the Erasmus University Medical Center faculty of Health Sciences Medical Informatics, said: "Nowadays, diabetes affects over 366 million people worldwide. Several safety risks associated with drugs used for treating diabetes have appeared over the last decade (such as the increased cardiovascular risks of rosiglitazone). Both factors have triggered the need for improvement of the drug approval systems and have called for advanced and reliable long-term benefit-risk assessment of these drugs.

Lead scientist Prof. Miriam Sturkenboom, of the Erasmus University Medical Center faculty of Health Sciences Medical Informatics, said: "Nowadays, diabetes affects over 366 million people worldwide. Several safety risks associated with drugs used for treating diabetes have appeared over the last decade (such as the increased cardiovascular risks of rosiglitazone). Both factors have triggered the need for improvement of the drug approval systems and have called for advanced and reliable long-term benefit-risk assessment of these drugs.

Only a collaborative endeavour allying experts from different research disciplines and including medical information for a large number of patients from several countries will permit the development of large studies, which are required for improving the understanding on how drugs act in T2DM treated patients and for the better monitoring of drug safety in the future."

The multidisciplinary group of experts in SAFEGUARD, with pharmacoepidemiologists, pharmacovigilance experts, pharmacologists, diabetes experts, clinicians and statisticians, 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 the investigation of: 1) published clinical trials and observational studies; 2) spontaneous reported adverse events reports in international pharmacovigilance databases; and 3) data from 9 population-based health care databases in 6 countries with anonymised medical data from more than 1.7 million T2DM patients. Results will aid defining the long-term benefit-risk profile of T2DM drugs. In addition, intensive mechanistic studies in human will be developed, for better understanding the untoward effects of T2DM drugs on cardiovascular, digestive and renal systems. Finally, with the integration of all information derived from the work in the project, a decision model will be developed to assist clinicians in better treatment choices and regulatory agencies in their decision making.

Notes to Editors:
Project Information:
The SAFEGUARD project (full title: Safety Evaluation of Adverse Reactions in Diabetes) is funded with 2.9 million Euro granted by the European Commission in the 7th Framework Programme, coordinated by Professor Dr. Miriam Sturkenboom of Erasmus University Medical Center (Netherlands) and carried out by 14 leading research institutions and SMEs.
SAFEGUARD started the 1st October 2011, with a duration of 36 months.

The full list of participating institutions is:

  • Erasmus Universitair Medisch Centrum Rotterdam (Netherlands)
  • Synapse Research Management Partners (Spain)
  • PHARMO Coƶperatie UA (Netherlands)
  • Fondazione Scientifica SIMG-ONLUS (Italy)
  • University of Bath (UK)
  • Agencia EspaƱola de Medicamentos y Productos Sanitarios (Spain)
  • Consorzio Mario Negri Sud (Italy)
  • Drug Safety Research Trust (UK)
  • Univerzita Karlova v Praze (Czech Republic)
  • VU University Medical Center (Netherlands)
  • The Brigham and Women's Hospital, Harvard Medical School (US)
  • University of Milano-Bicocca (Italy)
  • Universitaet Bremen (Germany)
  • RTI Health Solutions (US, and Spain)

Project webpage: www.safeguard-diabetes.org

For more information, contact:
Prof. Dr. Miriam Sturkenboom (Project Coordinator)
email: m.sturkenboom@erasmusmc.nl
tel: +31 10 704 41 26

Prof. Corinne de Vries
email: c.de-vries@bath.ac.uk
tel: +44 (0) 1225 384228

Ms. Mireia Manent (Project Manager)
email: mmanent@synapse-managers.com
tel: +34 933 006 061

 

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