Summary

One of the key challenges in drug development is improvement of patient safety: many drug side effects are not adequately predictable and often detected too late, when the risk for serious outcome is high. The scientists of the SAFE-T project are developing improved tools for prediction, detection, and monitoring of drug-induced injuries to the kidney, the liver, and the vascular system, using markers in patients’ blood and/or urine.

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Achievements & News

Smart SAFE-T strategy spots drug-induced liver injury
IMI project SAFE-T has devised a simple strategy that is able to identify patients with drug-induced liver injury before serious damage has occurred.###Writing in the journal PLoS ONE, the project team points out that 1 in 100 hospitalised patients experience liver injury as a result of an adverse drug reaction, but many cases are missed, especially in non-hepatology departments. The SAFE-T scientists used a common indicator of liver damage, namely alanine aminotransferase (ALT) levels. Using the SAFE-T strategy, all patients with ALT levels three times higher than the top end of the ‘normal’ range were referred to an experienced hepatologist. The SAFE-T strategy was compared to the hospital’s standard strategy, in which non-hepatologists refer suspected cases of drug induced liver injury (DILI) to experts. The results show that the SAFE-T strategy is much more sensitive, picking up 12 times more cases than the standard strategy and detecting cases of DILI while they are still in the earlier stages. ‘These results therefore strongly suggest that the centralized [SAFE-T] method could prevent very severe complications,’ the researchers write.
(November 2012)

Major kidney ‘SAFE-T’ studies get underway
The IMI project SAFE-T has enrolled the first patients into 4 major studies that aim to boost scientists’ ability to determine whether or not a potential drug will be toxic to the kidney.###Drug-induced kidney injury is a serious problem in drug development and the treatment of patients. All too often, currently-used tests only detect kidney damage when it is already irreversible. The new SAFE-T studies aim to assess the potential of biological markers (biomarkers) that could allow doctors and researchers to detect kidney damage while it is still in the early stages. People participating in the studies include patients treated with medicines known to be toxic to the kidney; people with kidney diseases; and kidney transplant recipients who take immunosuppressant drugs that could be harmful to the kidney. According to the team, putting together studies of this scale would not have been possible without intense interdisciplinary and cross-institutional collaboration. The first results from the studies are expected in six to nine months. In addition to drug-induced kidney injury, SAFE-T researchers are also working on improving tests to pick up on drug-induced liver and vascular problems. Large-scale studies in these areas have also been initiated by the consortium.
(July 2011)

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Participants

EFPIA

• Novartis Pharma AG, Basel, Switzerland
• Laboratorios Almirall S.A., BARCELONA, Spain
• Amgen, Bruxelles, Belgium
• AstraZeneca AB, Södertälje, Sweden
• Bayer Schering Pharma AG, Berlin, Germany
• Boehringer Ingelheim International GmbH, Ingelheim, Germany
• Eli Lilly And Company Limited, Basingstoke, UK
• GlaxoSmithKline Research and Development LTD, Brentford, UK
• Pfizer Limited, Sandwich, UK
• F. Hoffmann-La Roche AG, Basel, Switzerland
• Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France

Universities, Research Organisations, Public Bodies & Non-profit

• Naturwissenschaftliches und Medizinisches Institut an der Universität Tübingen, Reutlingen, Germany
• Charite - Universitaetsmedizin Berlin, Berlin, Germany
• Assistance Publique - Hopitaux De Paris, Paris, France
• Consorci Institut Català de Ciències Cardiovasculars, Barcelona, Spain
• The Foundation For Medical Research Infrastructural Development And Health Services, Tel Aviv, Israel

SMEs

• Firalis S.A.S., Huningue, France
• Argutus Medical LTD, Dublin, Ireland
• EDI Experimentelle und Diagnostische Immunologie GmbH, Reutlingen, Germany
• Interface Europe, Bruxelles, Belgium