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

Schindewolf, Marc; Scheuermann, Julia; Kroll, Hartmut; Marzi, Ingo; Kaufmann, Roland; Boehncke, Wolf-Henning; Ludwig, Ralf J; Lindhoff-Last, Edelgard (2012). Application, tolerance and safety of fondaparinux therapy in a German hospital: a prospective single-centre experience. Thrombosis research, 129(1), pp. 17-21. Elsevier 10.1016/j.thromres.2011.06.008

[img] Text
1-s2.0-S0049384811002957-main.pdf - Published Version
Restricted to registered users only
Available under License Publisher holds Copyright.

Download (172kB) | Request a copy

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' prescription practice, tolerance and therapy safety in a representative mixed German single-centre patient cohort.

PATIENTS AND 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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Angiology

UniBE Contributor:

Schindewolf, Marc

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0049-3848

Publisher:

Elsevier

Language:

English

Submitter:

Heidi Lobsiger

Date Deposited:

24 Sep 2015 07:58

Last Modified:

24 Sep 2015 07:58

Publisher DOI:

10.1016/j.thromres.2011.06.008

PubMed ID:

21741076

BORIS DOI:

10.7892/boris.71976

URI:

https://boris.unibe.ch/id/eprint/71976

Actions (login required)

Edit item Edit item
Provide Feedback