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Epidemiological study to investigate the utilization of the new anticoagulant rivaroxaban after market launch in Germany

Keyword:
rivaroxaban (look for word fragments)

Description

Rivaroxaban (Xarelto®) is a direct oral anticoagulant (DOAC) approved by the European Medicine Agency (EMA) in 2008 for the prevention of venous thromboembolism in patients undergoing elec-tive hip or knee replacement surgery in Europe. Due to its anticoagulant properties, bleeding events are the most important serious side effects observed in the registration trials. Since several patient groups show an increased risk of bleeding, specific precautions, warnings, and contraindications apply when using rivaroxaban. In light of this background, EMA demanded further studies from the manufacturer Bayer AG. As a part of the risk management plan, the pharmaceutical company is obliged to investigate the usage and the safety after market approval. The purpose of this drug utilization study was therefore to describe the use of rivaroxaban in Germany.

The focus of this cohort study based on data from the German Pharmacoepidemiological Research Database (GePaRD) , was an analysis of the indication and the duration of use to detect possible off-label use. Furthermore, comorbidity and comedication as defined in the product information were investigated to evaluate the compliance with precautions, warnings, and contraindications during use.

The project was completed in 2012 and the results were published in the European Journal of Clini-cal Pharmacology. Regarding indications, comorbidity, and comedication, most patients receiving rivaroxaban were found to have proper use. In contrast, the recommendations on the duration of rivaroxaban use were not followed by most patients.

Funding period

Begin:   December 2010
End:   December 2012

Sponsor

  • Bayer HealthCare

Contact

Dr. rer. medic. Tania Schink

Selected project-related publications

    Articles with peer-review

  • 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.
    http://dx.doi.org/10.1007/s00228-014-1697-7
  • Posters at scientific meetings/conferences

  • Jobski K, Enders D, Amann U, Suzart-Woischnik K, Wallander M-A, Schink T, Garbe E. Drug use pattern of Rivaroxaban in Germany. 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 25-28 August 2013, Montreal, Canada.