gms | German Medical Science

14. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

15.11. - 16.11.2007, Frankfurt am Main

Use of Fondaparinux for long term prophylaxis in high risk patients requiring artifical ventilation: results of a quality management survey

Meeting Abstract

  • corresponding author G. Grellmann - Bavaria Klinik, Kreischa
  • F. Oehmichen - Bavaria Klinik, Kreischa
  • M. Pohl - Bavaria Klinik, Kreischa
  • J. Hankowitz - Gesundheit + Medizin, München

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 14. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. Frankfurt am Main, 15.-16.11.2007. Düsseldorf: German Medical Science GMS Publishing House; 2007. Doc07gaa23

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/gaa2007/07gaa23.shtml

Published: November 12, 2007

© 2007 Grellmann et al.
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Outline

Text

Context: The optimal prophylaxis for prevention of venous thromboembolism in high risk patients requiring artificial ventilation remains a challenge due to the lack of results from randomized controlled clinical trials. Fondaparinux is a new synthetic antithrombotic drug with superior efficacy-/safety profile compared to low molecular weight heparins in preventing venous thromboembolism in major traumatology and orthopaedic surgery and preventing bleeding events in the treatment of acute coronary syndrome. Its efficacy is also shown in medical patients. Therefore, we use Fondaparinux 2.5 mg once daily for in-label use in high risk patients which require artificial ventilation within our quality management programme.

Aim of the study: The aim of the quality management survey is to document the efficacy and safety of Fondaparinux in high risk patients requiring artificial ventilation under real life conditions (effectiveness).

Material and method: All high risk patients receive Fondaparinux 2.5 mg once daily s.c. for duration of assisted ventilation. The high risk population represent surgical patients (traumatology, cardiology, neurology) and medical patients (chronic obstructive pulmonary disease (COPD), heart failure (NYHA II-IV), ischemic stroke, critical illness polyneuropathy). The mean prophylaxis duration was 25 (1-102) days.

Results: An interim analysis of 205 patients demonstrated the effectiveness and safety of Fondaparinux: The incidence of clinical VTE was 0.98% and no major bleeding was observed so far.

Conclusion: The net clinical benefit (effectiveness) of Fondaparinux has to be shown also under real life conditions, especially in patient population where randomized controlled trials are missing or cannot be conducted.