Fondaparinux, the first selective factor Xa inhibitor

Current Opinion in Hematology

Volumn 10, Issue 5, 2003, Pages 327-332

  Turpie, Alexander G G ^a   Eriksson, Bengt I ^b   Lassen, Michael R ^c   Bauer, Kenneth A ^d  

^a HAMILTON HEALTH SCIENCES   (Canada)

^b SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^c Hoersholm Hospital   (Denmark)

^d BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

Author keywords

Arterial thrombosis; Factor Xa inhibition; Fondaparinux; Venous thromboembolism

Indexed keywords

ACETYLSALICYLIC ACID; ALTEPLASE; ANTICOAGULANT AGENT; BLOOD CLOTTING FACTOR 10A INHIBITOR; ENOXAPARIN; FONDAPARINUX; HEPARIN; LOW MOLECULAR WEIGHT HEPARIN;

ACUTE HEART INFARCTION; ADULT; ANTICOAGULANT THERAPY; BLEEDING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DEEP VEIN THROMBOSIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; HUMAN; INCIDENCE; LUNG EMBOLISM; MAJOR CLINICAL STUDY; META ANALYSIS; MORTALITY; NORMAL HUMAN; ORTHOPEDIC SURGERY; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; POSTOPERATIVE CARE; PREGNANCY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; SIDE EFFECT; SURGICAL PATIENT; THROMBOEMBOLISM; THROMBOSIS PREVENTION; TOTAL HIP PROSTHESIS; WOUND INFECTION;

ACUTE DISEASE; ANTITHROMBIN III; CLINICAL TRIALS, PHASE II; CLINICAL TRIALS, PHASE III; CORONARY DISEASE; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; MALE; META-ANALYSIS; ORTHOPEDIC PROCEDURES; POLYSACCHARIDES; PREGNANCY; PREGNANCY COMPLICATIONS, CARDIOVASCULAR; RANDOMIZED CONTROLLED TRIALS; THROMBOEMBOLISM; TREATMENT OUTCOME; VENOUS THROMBOSIS;

EID: 0042703246     PISSN: 10656251     EISSN: None     Source Type: Journal    
DOI: 10.1097/00062752-200309000-00001     Document Type: Review

References (26)

1. Geerts WH, Heit JA, Clagett GP, et al.: Prevention of venous thromboembolism. Chest 2001, 119:132S-175S.
2. Hirsh J, Warkentin TE, Shaughnessy SG, et al.: Heparin and low-molecular-weight heparin: mechanisms of action, pharmacokinetics, dosing, monitoring, efficacy, and safety. Chest 2001, 119:64S-94S.
3. Hirsh J, Dalen JE, Anderson DR, et al.: Sixth ACCP Consensus Conference on antithrombotic therapy. Oral Anticoagulants. Mechanism of action, clinical effectiveness, and optimal therapeutic range. Chest 2001, 119:8S-21S.
4. Herbert JM, Petitou M, Lormeau JC, et al.: SR 90107A/Org 31540, a novel anti-factor Xa antithrombotic agent. Cardiovasc Drug Rev 1997, 15:1-26.
5. Donat F, Duret JP, Santoni A, et al.: The pharmacokinetics of fondaparinux sodium in healthy volunteers. Clin Pharmacokinet 2002, 41:1-9.
6. Paolucci F, Clavies M, Donat F, et al.: Fondaparinux sodium mechanism of action: identification of specific binding to purified and human plasma-derived proteins. Clin Pharmacokinet 2002, 41:11-18.
7. Faaij RA, Burggraaf J, Schoemaker RC, et al.: The synthetic pentasaccharide fondaparinux sodium does not interact with oral warfarin. Clin Pharmacokinet 2002, 41:27-29.
8. Ollier C, Santoni A, Faaij RA, et al.: Absence of interaction of fondaparinux sodium with aspirin and piroxicam in healthy male volunteers. Clin Pharmacokinet 2002, 41:31-37.
9. Mant T, Fournié P, Ollier C, et al.: Absence of interaction of fondaparinux sodium with digoxin in healthy volunteers. Clin Pharmacokinet 2002, 41:39-45.
10. Turpie AGG, Gallus AG, Hoek JA: A synthetic pentasaccharide for the prevention of deep-vein thrombosis after total hip replacement. N Engl J Med 2001, 344:619-625.
11. Lassen MR, Bauer KA, Eriksson BI, et al.: Fondaparinux versus enoxaparin for the prevention of venous thromboembolism in elective hip replacement surgery. A randomised double-blind comparison. Lancet 2002, 359:1715-1720. References 11-15 are of outstanding interest because they represent the only completed phase III trials on factor Xa inhibition in the prevention of VTE following major orthopedic surgery. As well as establishing the efficacy of fondaparinux in the prophylaxis of VTE, these trials also characterized the tolerability profile of fondaparinux, paving the way for its use in other indications.
12. Turpie AGG, Bauer KA, Eriksson BI, et al.: A randomised double-blind comparison of fondaparinux with enoxaparin for the prevention of venous thromboembolism after elective hip replacement surgery. Lancet 2002, 359:1721-1726. See [11••].
13. Bauer KA, Eriksson BI, Lassen MR, et al.: Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after elective major knee surgery. N Engl J Med 2001, 345:1305-1310. See [11••].
14. Eriksson BI, Bauer KA, Lassen MR, et al.: Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after hip-fracture surgery. N Engl J Med 2001, 345:1298-1304. See [11••].
15. Turpie AGG, Bauer KA, Eriksson BI, et al.: Fondaparinux vs enoxaparin for the prevention of venous thromboembolism in major orthopedic surgery, A meta-analysis of 4 randomized double-blind studies. Arch Intern Med 2002, 162:1833-1840. See [11••].
16. th World Congress of the Societe Internationale de Chirurgie Orthopédique et de Traumatologie (SICOT). San Diego, California. August 23-30, 2002: Abstract book 430E:337.
17. Turpie AGG, Bauer KA, Eriksson BI, et al.: Effect on efficacy and safety of the timing of the first administration of fondaparinux (Arixtra) in the prophylaxis of venous thromboembolism following major orthopaedic surgery [abstract]. Hematol J 2002, 3:365.
18. Büller HR, Cariou R, Gallus A, et al.: Treatment of proximal deep vein thrombosis with a novel synthetic compound (SR90107A/ORG31540) with pure anti-factor Xa activity. Circulation 2000, 102:2726-2731.
19. MATISSE: Fondaparinux (Arixtra) in comparaison to (low-molecular-weight) heparin for the initial treatment of symptomatic deep venous thrombosis or pulmonary embolism - The Matisse clinical outcome studies. Blood 2002, 100:83a.
20. Vuillemenot A, Schiele F, Meneveau N, et al.: Efficacy of a synthetic pentasaccharide, a pure factor Xa inhibitor, as an antithrombotic agent - a pilot study in the setting of coronary angioplasty. Thromb Haemost 1999, 81:214-220.
21. th Annual Scientific Sessions of the American Heart Association, Anaheim, California. November 14, 2001.
22. Coussement PK, Bassand J-P, Convens C, et al.: A synthetic factor-Xa inhibitor (ORG31540/SR90107A) as an adjunct to fibrinolysis in acute myocardial infraction. The PENTALYSE study. Eur Heart J 2001, 22:1716-1724.
23. Lagrange F, Vergnes C, Paolucci F, et al.: Absence of placental transfer of pentasaccharide (fondaparinux, Arixtra) in the dually perfused human cotyledon in vitro. Thromb Haemost 2002, 87:831-835.
24. Bijsterveld NR, Moons AH, Boekholdt M, et al.: Ability of recombinant factor VIIa to reverse the anticoagulant effect of the pentasaccharide fondaparinux in healthy volunteers. Circulation 2002, 106:2550-2554.
25. Elalamy I, Lecrubier C, Potevin F, et al.: Absence of in vitro cross-reaction of pentasaccharide with the plasma heparin-dependent factor of twenty-five patients with heparin associated thrombocytopenia. Thromb Haemost 1995, 74:1384-1385.
26. Amiral J, Lormeau JC, Marfaing-Koka A, et al.: Absence of cross-reactivity of SR90107A/ORG31540 pentasaccharide with antibodies to heparin-PF4 complexes developed in heparin-induced thrombocytopenia. Blood Coag Fibrinolysis 1997, 8:114-117.