Application, tolerance and safety of fondaparinux therapy in a German hospital: A prospective single-centre experience

作者:Schindewolf Marc*; Scheuermann Julia; Kroll Hartmut; Marzi Ingo; Kaufmann Roland; Boehncke Wolf Henning; Ludwig Ralf J; Lindhoff Last Edelgard
来源:Thrombosis Research, 2012, 129(1): 17-21.
DOI:10.1016/j.thromres.2011.06.008

摘要

Introduction: The pentasaccharide fondaparinux is widely approved for prophylaxis and treatment of thromboembolic diseases and therapy of acute coronary syndrome. It is also used off-label in patients with acute, suspected or antecedent heparin-induced thrombocytopenia (HIT). The aim of this prospective observational cohort study was to document fondaparinux%26apos; prescription practice, tolerance and therapy safety in a representative mixed German single-centre patient cohort. %26lt;br%26gt;Patients and Methods: Between 09/2008 - 04/2009, 231 consecutive patients treated with fondaparinux were enrolled. Medical data were obtained from patient%26apos;s records. The patients were clinically screened for thrombosis (Wells score), sequelae of HIT (4T%26apos;s score), and bleeding complications (ISTH-criteria) and subjected to further assessment (i.e. sonography, HIT-diagnostics), if necessary. The mortality rate was assessed 30 days after therapy start. %26lt;br%26gt;Results: Overall, 153/231 patients had a prophylactic, 74/231 patients a therapeutic, and 4/231 patients a successive prophylactic/therapeutic indication. In 11/231 patients fondaparinux was used due to suspected/antecedent HIT, in 5/231 patients due to a previous cutaneous delayed-type hypersensitivity to heparins. Other indications were rare. Three new/progressive thromboses were detected. No cases of HIT, major bleedings, or fatalities occurred. %26lt;br%26gt;Conclusions: Fondaparinux was well tolerated and was safe in prophylaxis and therapy; prescriptions mostly followed the current approval guidelines and were rarely related to HIT-associated indications (%26lt;5% of prescriptions), which is in contrast to previous study results in the U. S. (%26gt;94% of prescriptions were HIT-associated). A trend towards an individualised fondaparinux use based on the compound%26apos;s inherent properties and the patients%26apos; risk profiles, i.e., antecedent HIT, bone fractures, heparin allergy, was observed.

  • 出版日期2012-1