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28. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie (GAA)

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

11.11. - 12.11.2021, digital

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Serious Adverse Drug Reactions of Fluoroquinolones: a Pharmacoepidemiological Real World Data Analysis – Study Protocol

Meeting Abstract

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  • author presenting/speaker Julia Wicherski - Federal Institute for Drugs and Medical Devices (BfArM), Pharmacoepidemiology, Bonn, Germany
  • Steffen Heß - Federal Institute for Drugs and Medical Devices (BfArM), Pharmacoepidemiology, Bonn, Germany
  • Christoph Röthlein - German Center for Neurodegenerative Diseases (DZNE), Pharmacoepidemiology in Neurodegenerative Disorders (DZNE), Bonn, Germany
  • Katrin Schüssel - Scientific Institute of the AOK (WIdO), Berlin, Germany
  • Gabriela Brückner - Scientific Institute of the AOK (WIdO), Berlin, Germany
  • Andreas Schlotmann - Scientific Institute of the AOK (WIdO), Berlin, Germany
  • Helmut Schröder - Scientific Institute of the AOK (WIdO), Berlin, Germany
  • Winfried Kern - Division of Infectious Diseases, Department of Medicine II, Medical Center-University of Freiburg, Freiburg, Germany
  • Birgitta Weltermann - Institute of General Practice and Family Medicine, University of Bonn, Bonn, Germany
  • corresponding author Britta Haenisch - Federal Institute for Drugs and Medical Devices (BfArM), Pharmacoepidemiology, German Center for Neurodegenerative Diseases (DZNE), Pharmacoepidemiology in Neurodegenerative Disorders (DZNE), University of Bonn, Center for Translational Medicine, Bonn, Germany

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 28. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. sine loco [digital], 11.-12.11.2021. Düsseldorf: German Medical Science GMS Publishing House; 2021. Doc21gaa16

doi: 10.3205/21gaa16, urn:nbn:de:0183-21gaa166

Veröffentlicht: 10. November 2021

© 2021 Wicherski et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.

Gliederung

Text

Background: Restrictions and changes in fluoroquinolone (FQ) use have been established as a consequence of the risk assessment report from the European Medicines Agency in 2019. However, FQs are frequently prescribed in Germany. This study aims to add recent evidence on FQ-associated risks for several serious adverse drug reactions (ADRs) of cardiovascular, cardiologic, hepatotoxic, nervous system-related, muscular, connective tissue-related or retinal nature.

Materials and Methods: Our cohort study is based on longitudinal routine data from the AOK, a large German statutory health insurance. Our dataset covers a seven-year study period (2013–2019) with an individual one-year follow-up period of adult patients with filled antibiotic prescriptions. FQ-associated risks are estimated from Cox proportional hazards regression models with outcome-specific covariate adjustment. If applicable, accelerated failure time models will be applied for additional time-to-event information.

Results: Details of the study protocol will be presented; results regarding the modified risk for aortic aneurysms are expected to be available at the end of 2021. Insights into all analysed ADRs are expected to be available next year.

Conclusion: We will generate real world evidence for FQ-associated risks for serious ADRs in routine care and contribute valuable comparative information on drug safety between FQs and compared to other systemic antibiotic drugs.