Utilization, effectivity, and safety of direct oral anticoagulants (DOAC)
In everyday language, anticoagulation is often referred to as blood thinning. This therapeutic or prophylactic method is necessary in patients with a disposition for developing blood clots (thrombi). For a long time, vitamin K antagonists were the standard therapy for oral anticoagulation. In Germany, phenprocoumon (PPC, e.g. Marcumar®) is almost exclusively prescribed from this active ingredient group. In 2008, direct oral anticoagulants (DOACs), an additional class of anticoagulant drugs acting directly in the coagulation cascade, were approved. Since these agents have only been available for a few years, the alternative term new oral anticoagulants (NOACs) is also used. Several extensions of the indications of the agents apixaban, dabigatran, and rivaroxaban which are available in Germany led to a significant increase of usage.
Due to their anticoagulant properties, DOACs as well as other anticoagulants are associated with an increased risk of bleeding. So far, further potential side effects cannot be assessed because of the limited number of cases in the registration trials. It is also unclear to what extent the findings of these studies can be transferred to everyday practice in Germany, to long-term therapy, and to patients with comorbidities. Therefore, this research focus aims to characterize DOAC users and users of the respective comparative treatment (PPC or antiplatelet drugs) and to compare the frequency of severe adverse side effects between these groups. Further outcomes related to the effectiveness of treatment will be investigated to facilitate a risk-benefit assessment.
- Drug interactions and the risk of serious hemorrhage in patients receiving phenprocoumon (PhenBleed2)
- Epidemiological study to investigate the utilization of the new anticoagulant rivaroxaban after market launch in Germany (Antikoagulans-DUS)
- Post-authorization safety study investigating the bleeding risk in patients treated with rivaroxaban (Antikoagulans-PASS)
- Jobski K, Enders D, Amann U, Suzart K, Wallander M-A, Schink T, Garbe E. Use of rivaroxaban in Germany: A database drug utilization study of a drug started in hospital. European Journal of Clinical Pharmacology. 2014;70(8):975-981. dx.doi.org/10.1007/s00228-014-1697-7.
- Jobski K, Behr S, Garbe E. Drug interactions with phenprocoumon and the risk of serious haemorrhage: A nested case-control study in a large population-based German database. European Journal of Clinical Pharmacology. 2011;67(9):941-951. dx.doi.org/10.1007/s00228-011-1031-6.
- Bezemer I, Schink T, García Rodríguez LA, Friberg L, Balabanova Y, Brobert G, Suzart-Woischnik K, Vora P, Ruigómez A, Herings, R. The introduction of new anticoagulation therapy in the European Union: The case of rivaroxaban. 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), August 22-26, 2018, Prague, Czech Republic.
- Fassmer A, Jobski K, Haug U, Schink T. Rivaroxaban vs. phenprocoumon use in Germany and risk of bleeding: A claims data analysis based on 80,000 patients. Congress "Health - Exploring Complexity: An Interdisciplinary Systems Approach (HEC2016)." Joint Annual Meeting of the German Society for Medical Informatics, Biometry and Epidemiology (GMDS), the German Society for Epidemiology (DGEpi), the International Epidemiological Association - European Region (IEA-EEF) and the European Federation for Medical Informatics Association (EFMI), 28 August-2 September 2016, Munich.