Einzelansicht

SAFEGUARD - Safety Evaluation of Adverse Reactions in Diabetes

Beschreibung

In einem europäischen Verbund von Forschergruppen wurden in diesem Projekt die Risikoprofile von neueren blutzuckersenkenden Arzneimitteln bei Diabetes mellitus Typ 2 (z.B. Glitazone, Inkretine) erforscht und mit älteren Wirkstoffen (z.B. aus den Gruppen der Biguanide oder Sulfonylharnstoffe) verglichen. Hierzu wurden neben einer systematischen Übersicht bisher veröffentlichter Studien auch Spontanmeldedaten analysiert sowie Beobachtungsstudien auf Basis verschiedener Datenbanken aus mehreren europäischen Ländern und den USA durchgeführt. Im Vordergrund stand dabei die Untersuchung möglicherweise erhöhter Risiken für zerebro- und kardiovaskuläre Ereignisse (Schlaganfall, ventrikuläre Arrhythmien, plötzlicher Herztod) sowie für Krebserkrankungen (Bauchspeicheldrüsenkrebs, Blasenkrebs) und akute Pankreatitis. Das BIPS war insbesondere bei der Analyse der Spontanmeldedaten, der Durchführung der Beobachtungsstudien auf Basis der Deutschen Pharmakoepidemiologischen Forschungsdatenbank sowie bei der Entwicklung der statistischen Modellierung involviert.

Die Auswertungen sind inzwischen abgeschlossen. Erste Ergebnisse wurden bereits auf internationalen Konferenzen vorgestellt und die entsprechenden Publikationen sind in Arbeit.

Förderzeitraum

Beginn:   Oktober 2011
Ende:   September 2015

Förderer

  • Europäische Kommission (7. EU-Forschungsrahmenprogramm)

Kontaktperson

Dr. rer. medic. Tania Schink

Projektleitung (international)

Dr. Miriam CJM Sturkenboom, Erasmus University Medical Center

Kooperationspartner

  • Agencia Espanola de Medicamentos y Productos Sanitarios, Spanien
  • Consorzio Mario Negri Sud, Italien
  • Drug Safety Research Trust, Großbritannien
  • Erasmus Universitair Medisch Centrum Rotterdam (EMC), Rotterdam, Niederlande
  • Fondatione Scientifica SIMG-ONLUS, Italien
  • PHARMO Coöperatie U.A, Niederlande
  • Research Triangle Institute, Spanien
  • Synapse Research Management Partners S.L., Spanien
  • The Brigham and Women´s Hospital, Inc., USA
  • Universita Degli Studi di Milano-Bicocca, Italien
  • University of Bath, Großbritannien
  • Univerzita Karlova V Praze, Tschechien
  • Vereniging Voor Christlijk Hoger Onderwijs Wetenschappelijk Onderzoek En Patientenzorg, Niederlande

Link

http://www.safeguard-diabetes.org/

Ausgewählte Veröffentlichungen zum Projekt

    Vorträge bei wissenschaftlichen Tagungen

  • Leal I, Masclee G, Scotti L, de Berardis G, Bezemer I, Gil M, Martín E, McGregor A, Schmedt N, Seeger J, Trifirò G, Pecchioli S, Varas-Lorenzo C, Smits M, Rijnbeek P, Sturkenboom MCJM, Romio S. Risk of acute myocardial infarction associated with non-insulin blood glucose lowering drugs. Results from the SAFEGUARD project. 32nd International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 25-28 August 2016, Dublin, Ireland.
  • Masclee G, Leal I, Scotti L, de Berardis G, Bezemer I, Gil M, McGrogan A, Schmedt N, Seeger J, Trifirò G, Pecchioli S, Pladevall-Vila M, Smits M, Rijnbeek P, Sturkenboom MCJM, Romio S. Use of non-insulin blood glucose lowering drugs and the risk of acute pancreatitis. 32nd International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 25-28 August 2016, Dublin, Ireland.
  • Hazell L, Schmedt N, Scotti L, Leal I, Trifirò G, Sturkenboom MCJM, Shakir S. SAFEGUARD results: Analysis of pharmacovigilance databases. 30th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 24-27 October 2014, Taipei, Taiwan.
  • Leal I, Masclee G, Scotti L, de Berardis G, Bezemer I, Gil M, Martín E, Sammon C, Schmedt N, Seeger J, Trifirò G, Pecchioli S, Varas-Lorenzo C, Smits M, Rijnbeek P, Sturkenboom MCJM, Romio S. Identification of type 2 diabetes mellitus in different electronic databases within the SAFEGUARD project. 30th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 24-27 October 2014, Taipei, Taiwan.
  • Poster bei wissenschaftlichen Tagungen

  • Gil M, Romio S, Scotti L, Leal I, Masclee G, Schmedt N, Varas-Lorenzo C, Pladevall M, Smits M, Benzemer I, McGrogan A, Seeger J, de Berardis G, Trifirò G, Rijnbeek P, Sturkenboom MCJM. Risk of hemorrhagic stroke associated with non-insulin blood glucose lowering drugs. Results from the SAFEGUARD project. 32nd International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 25-28 August 2016, Dublin, Ireland.
  • Hazell L, Schmedt N, Scotti L, Leal I, Trifirò G, Sturkenboom MCJM, Shakir S. Development of a qualitative method to assist in interpretation of results from disproportionality analyses in the SAFEGUARD project. 18th Annual European Congress of the International Society for Pharmacoepidemiology (ISPE), 7-11 November 2015, Milan, Italy.
  • Leal I, Sammon C, Masclee G, Scotti L, de Berardis G, Bezemer I, Gil M, Martín E, McGrogan A, Schmedt N, Seeger J, Trifirò G, Pecchioli S, Varas-Lorenzo C, Smits M, Rijnbeek P, Sturkenboom MCJM, Romio S. Trends of use of non-insulin blood glucose lowering drugs in Europe and USA. 31st International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 22-26 August 2015, Boston, USA. (Abstract published in: Pharmacoepidemiology and Drug Safety. 2015;24(Suppl. 1):106)
  • Masclee G, Leal I, Rijnbeek P, Trifirò G, Sammon C, Bezemer I, Smits M, Scotti L, Hazell L, de Berardis G, Gil M, Martín E, Requena G, Pecchioli S, Schmedt N, Schink T, Seeger J, Pladevall M, Kuipers EJ, Sturkenboom MCJM, Romio S. Comparison of incidence rates of acute pancreatitis and pancreatic cancer among the general population and type 2 diabetes mellitus patients between different databases in the SAFEGUARD project. Digestive Disease Week, 3-6 May 2014, Chicago, USA.
  • Masclee G, Leal I, Rijnbeek P, Trifirò G, Sammon C, Bezemer I, Smits M, Scotti L, Hazell L, de Berardis G, Gil M, Martín E, Requena G, Pecchioli S, Schmedt N, Schink T, Seeger J, Pladevall M, Kuipers EJ, Sturkenboom MCJM, Romio S. Comparison of incidence rates of acute pancreatitis and pancreatic cancer among the general population and type 2 diabetes mellitus patients between different databases in the SAFEGUARD project. Spring Meeting of the Dutch Society for Gastroenterology and Hepatology, 20-21 March 2014, Veldhoven, The Netherlands.
  • Romio S, Scotti L, Hazell L, Schmedt N, Sturkenboom MCJM, Corrao G. Comparison of different methods for controlling false positives in adverse event reports analysis. 35th Annual Conference of the International Society for Clinical Biostatistics, 24-28 August 2014, Vienna, Austria.
  • Scotti L, Romio S, Zambon A, Hazell L, Schmedt N, Sturkenboom MCJM, Corrao G. The positive false discovery rate method to control the multiplicity problem in pharmacovigilance: The SAFEGUARD project. 30th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 24-27 October 2014, Taipei, Taiwan.
  • Masclee G, Romio S, Leal I, de Berardis G, Bezemer I, Gil M, Martín E, Requena G, Sammon C, Schmedt N, Seeger J, Scotti L, Trifirò G, Varas-Lorenzo C, de Vries C, Smits M, Rijnbeek P, Sturkenboom MCJM. Harmonization of diagnoses for acute pancreatitis identification from different databases in the SAFEGUARD project. 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 25-28 August 2013, Montreal, Canada.
  • Masclee G, Sturkenboom MCJM, Leal I, de Berardis G, Bezemer I, Gil M, Martín E, Requena G, Sammon C, Schmedt N, Seeger J, Scotti L, Trifirò G, Varas-Lorenzo C, de Vries C, Smits M, Rijnbeek P, Romio S. Harmonization of acute myocardial infarction identification from different databases in the SAFEGUARD project. 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 25-28 August 2013, Montreal, Canada.
  • Sammon C, de Berardis G, Nicolucci A, Bezemer I, Requena G, Gil M, Martín E, Leal I, Masclee G, Mazzaglia G, Rijnbeek P, Romio S, Schmedt N, Scotti L, Seeger J, Smits M, Varas-Lorenzo C, Sturkenboom MCJM, de Vries C. Harmonisation of event definitions across electronic healthcare databases; pancreatic and bladder cancer as a case study. 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 25-28 August 2013, Montreal, Canada.
  • Schmedt N, Bezemer I, de Berardis G, de Vries C, Gil M, Hense S, Leal I, Martín E, Masclee G, Trifirò G, Requena G, Rijnbeek P, Romio S, Sammon C, Scotti L, Seeger J, Smits M, Schink T, Varas-Lorenzo C, Sturkenboom MCJM, Garbe E. Benchmarking of definitions and algorithms to extract outcome events in the EU-funded SAFEGUARD project. 8. Jahrestagung der Deutschen Gesellschaft für Epidemiologie (DGEpi), 24.-27. September 2013, Leipzig.
  • Schmedt N, Gil M, Martín E, Requena G, Bezemer I, de Berardis G, de Vries C, Leal I, Masclee G, Mazzaglia G, Rijnbeek P, Romio S, Sammon C, Scotti L, Seeger J, Smits M, Schink T, Varas-Lorenzo C, Sturkenboom MCJM, Garbe E. Harmonization of outcome extraction for ischemic and hemorrhagic stroke across data sources in the SAFEGUARD project. 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 25-28 August 2013, Montreal, Canada.
  • Scotti L, Arfè A, Zambon A, Romio S, Schmedt N, de Berardis G, Sammon C, Gil M, Martín E, Requena G, de Vries C, Seeger J, Mazzaglia G, Bezemer I, Varas-Lorenzo C, Smits M, Rijnbeek P, Sturkenboom MCJM, Corrao G. Harmonization of outcome extraction for heart failure across data sources in the SAFEGUARD project. 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 25-28 August 2013, Montreal, Canada.
  • Seeger J, Romio S, Varas-Lorenzo C, Scotti L, Arfè A, Zambon A, Gil M, Requena G, Bezemer I, de Berardis G, de Vries C, Leal I, Masclee G, Trifirò G, Rijnbeek P, Sammon C, Schmedt N, Smits M, Carrao G, Sturkenboom MCJM. Total mortality rates across multiple databases: Benchmarking results from a distributed data network - The SAFEGUARD Project. 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 25-28 August 2013, Montreal, Canada.