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Fondaparinux Sodium

A Review of its Use in the Treatment of Acute Venous Thromboembolism

American Journal of Cardiovascular Drugs volume 5, pages 335–346 (2005)Cite this article

Summary

Abstract

Fondaparinux sodium (fondaparinux) is a synthetic sulfated pentasaccharide anticoagulant developed from the antithrombin binding moiety of heparin. Through the activation of antithrombin it inhibits Factor Xa, the activation of thrombin, and the subsequent coagulation cascade. Fondaparinux is approved in Europe and the US for the treatment of acute venous thromboembolism (VTE), including both deep vein thrombosis (DVT) and pulmonary embolism (PE), when used in conjunction with warfarin.

In phase III clinical trials, subcutaneous fondaparinux was noninferior to subcutaneous enoxaparin or intravenous unfractionated heparin (UFH) in the prevention of recurrent symptomatic VTE in patients with acute DVT and PE, respectively, and equally well tolerated. It thus provides a valuable alternative to UFH and low-molecular weight heparins in the treatment of acute VTE, particularly in the outpatient setting.

Pharmacological Properties

Fondaparinux, a sulfated pentasaccharide, inhibits Factor Xa by catalyzing a conformational change in antithrombin that potentiates the inhibitory activity of antithrombin →300-fold. Fondaparinux may also inhibit Factors VIIa and IXa, but with a Factor Xa rate constant for inactivation >25-fold higher than that of Factors VIIa and IXa, their inhibition is unlikely to play a role in the pharmacologic actions of fondaparinux.

In animal models of venous stasis thrombosis and dynamic thrombus growth, intravenous or subcutaneous fondaparinux inhibited thrombus generation and development in a dose-dependent manner.

The pharmacokinetic profile of fondaparinux following subcutaneous administration is characterized by high bioavailability (>100%) and slow elimination (mean terminal elimination half-life 13.1–20.7 hours) allowing once-daily administration. The volume of distribution (8.2–10.2L) suggests that fondaparinux is limited to the vascular compartment. Fondaparinux is highly bound to circulating antithrombin (>94%) and has negligible binding to other plasma proteins.

In patients with VTE, the bodyweight-adjusted fondaparinux dose regimen (5.0mg in patients weighing <50kg, 7.5mg in patients weighing 50–100kg, and 10mg in patients weighing >100kg) provided similar drug exposure across all bodyweight categories. At steady state, mean peak plasma concentration (Cmax) was 1.41 mg/L, time to reach Cmax was 2.4 hours, and the minimum plasma concentration was 0.52 mg/L.

When administered subcutaneously, 64–75% of fondaparinux in a dose range of 2–10mg is excreted in the urine. Fondaparinux is not metabolized by liver enzymes and does not inhibit cytochrome P450 isoenzymes. In healthy volunteers, fondaparinux clearance is correlated with creatinine clearance.

Therapeutic Efficacy

In two large, 3-month, phase III trials, subcutaneous fondaparinux was noninferior to either subcutaneous enoxaparin or intravenous UFH in the prevention of recurrent VTE in patients with DVT or PE. In the double-blind MATISSE (Mondial Assessment of Thromboembolism treatment Initiated by Synthetic pentasaccharide with Symptomatic Endpoints)-DVT trial, the incidence of recurrent VTE in patients with DVT was 3.9% in patients receiving fondaparinux and 4.1% in patients receiving enoxaparin. In the nonblind MATISSE-PE trial, the incidence of recurrent VTE was 3.8% in patients receiving fondaparinux and 5.0% in those receiving UFH.

After 3 months in a phase II dose-ranging trial, thrombotic burden, as measured by repeat ultrasound and perfusion scans, was improved in 45.2% of fondaparinux and 48.7% of dalteparin recipients, while recurrent VTE occurred in 2.4% of fondaparinux and 5.0% of dalteparin recipients.

Tolerability

Fondaparinux was generally well tolerated in patients with DVT or PE. The incidence of major bleeding during initial parenteral anticoagulation therapy was similar in fondaparinux (0.8–2.9%), enoxaparin (1.2%), dalteparin (0%), and UFH (1.1%) recipients. Major or nonmajor bleeding during the initial treatment period occurred with similar incidences in fondaparinux, enoxaparin, and UFH treatment groups, and no differences were observed in the incidence of major or nonmajor bleeding throughout the entire trial period, including subsequent vitamin K antagonist treatment.

As a result of increased fondaparinux exposure, patients with impaired renal function had a greater incidence of bleeding-related adverse events than did those with normal renal function. Mortality occurred at similar rates in fondaparinux and comparator treatment groups in the MATISSE-PE and -DVT trials.

Thrombocytopenia was observed in 10 (0.9%) fondaparinux recipients and 13 (1.2%) UFH recipients. In the MATISSE-DVT trial, 7 (0.6%) patients in each of the fondaparinux and enoxaparin treatment groups experienced thrombocytopenia.

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Notes

  1. The use of tradenames is for product identification purposes only and does not imply endorsement.

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  1. Adis International Inc., 770 Township Line Road, Suite 300, Yardley, Pennsylvania, 19067, USA

    Dean M. Robinson & Keri Wellington

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Correspondence to Dean M. Robinson.

Additional information

Various sections of the manuscript reviewed by:

J.J. Badimon, Mount Sinai School of Medicine, New York, New York, USA; H.R. Büller, Department of Vascular Medicine, University of Amsterdam, The Netherlands; A. Gallus, Department of Haematology and Genetic Pathology, Flinders Medical Centre, Adelaide, South Australia, Australia; T.M. Hyers, Department of Internal Medicine, St Louis University School of Medicine, St Louis, Missouri, USA; J.M. Walenga, Cardiovascular Institute, Loyola University Medical Centre, Loyola University, Chicago, Illinois, USA; F. Piovella, Thromboembolic Disease Unit, I.R.C.C.S. Policlinico San Matteo, University of Pavia, Pavia, Italy.

Data Selection

Sources: Medical literature published in any language since 1980 on fondaparinux sodium’, identified using Medline and EMBASE, supplemented by AdisBase (a proprietary database of Adis International). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.

Search strategy: Medline search terms were fondaparinux sodium’ or ‘SR-90107’ or ‘ORG31540’and (‘deep vein thrombosis’ or ‘venous thrombosis’ or ‘pulmonary embolism’). EMBASE search terms were fondaparinux sodium’ and (‘deep vein thrombosis’ or ‘pulmonary embolism’). AdisBase search terms were fondaparinux sodium’ or ‘SR-90107’and (‘deep vein thrombosis’ or ‘pulmonary embolism’). Searches were last updated 1 August 2005.

Selection: Studies in patients with deep vein thrombosis or pulmonary embolism who received fondaparinux sodium. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Fondaparinux sodium, pulmonary embolism, deep vein thrombosis, pharmacodynamics, pharmacokinetics, therapeutic use.

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Robinson, D.M., Wellington, K. Fondaparinux Sodium. Am J Cardiovasc Drugs 5, 335–346 (2005). https://doi.org/10.2165/00129784-200505050-00007

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Keywords

  • Pulmonary Embolism
  • Deep Vein Thrombosis
  • Enoxaparin
  • Fondaparinux
  • Fondaparinux Sodium