title: Application, tolerance and safety of fondaparinux therapy in a German hospital: a prospective single-centre experience.
abstract: BACKGROUND
  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' prescription practice, tolerance and therapy safety in a representative mixed German single-centre patient cohort.
  
  
  METHODS
  Between 09/2008 - 04/2009, 231 consecutive patients treated with fondaparinux were enrolled. Medical data were obtained from patient's records. The patients were clinically screened for thrombosis (Wells score), sequelae of HIT (4T'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.
  
  
  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.
  
  
  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 (<5% of prescriptions), which is in contrast to previous study results in the U.S. (>94% of prescriptions were HIT-associated). A trend towards an individualised fondaparinux use based on the compound's inherent properties and the patients' risk profiles, i.e., antecedent HIT, bone fractures, heparin allergy, was observed.
authors: Department of Internal Medicine, Division of Vascular Medicine and Haemostaseology, J.W. Goethe University Hospital Frankfurt am Main, Germany. marc.schindewolf@kgu.de
authors: Marc
authors: M
authors: Schindewolf
authors: Julia
authors: J
authors: Scheuermann
authors: Hartmut
authors: H
authors: Kroll
authors: Ingo
authors: I
authors: Marzi
authors: Roland
authors: R
authors: Kaufmann
authors: Wolf-Henning
authors: WH
authors: Boehncke
authors: Ralf J
authors: RJ
authors: Ludwig
authors: Edelgard
authors: E
authors: Lindhoff-Last
mesh_terms: D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D004342:Drug Hypersensitivity / Q000209:etiology; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D005260:Female; D000077425:Fondaparinux; D005858:Germany; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000009:adverse effects; D006785:Hospitals, University / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011134:Polysaccharides / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013921:Thrombocytopenia / Q000209:etiology; D013927:Thrombosis / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D011134:Polysaccharides; D006493:Heparin; D000077425:Fondaparinux