Idraparinux and idrabiotaparinux

Expert Review of Clinical Pharmacology

Volumn 3, Issue 1, 2010, Pages 9-16

  Harenberg, Job ^a  

^a UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

Atrial fibrillation; Idrabiotaparinux; Idraparinux; Thrombosis

Indexed keywords

ACENOCOUMAROL; ANTITHROMBIN; AVIDIN; DABIGATRAN ETEXILATE; ENOXAPARIN; FONDAPARINUX; HEPARIN; IDRABIOTAPARINUX; IDRAPARINUX; LOW MOLECULAR WEIGHT HEPARIN; PLACEBO; RECOMBINANT BLOOD CLOTTING FACTOR 7A; TINZAPARIN; WARFARIN;

ANTICOAGULATION; AREA UNDER THE CURVE; BLEEDING; BRAIN HEMORRHAGE; DEEP VEIN THROMBOSIS; DOSE RESPONSE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG COMPETITION; DRUG EFFICACY; DRUG ELIMINATION; DRUG FATALITY; DRUG HALF LIFE; DRUG METABOLISM; DRUG POTENCY; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG WITHDRAWAL; EMBOLISM; EPIGASTRIC DISCOMFORT; GASTROINTESTINAL HEMORRHAGE; HEART ATRIUM FIBRILLATION; HEPARIN INDUCED THROMBOCYTOPENIA; HUMAN; INJECTION SITE BLEEDING; INTERNATIONAL NORMALIZED RATIO; LUNG EMBOLISM; MAXIMUM PLASMA CONCENTRATION; NONHUMAN; REPEATED DRUG DOSE; REVIEW; SIDE EFFECT; SINGLE DRUG DOSE; SKIN DEFECT; STROKE; THROMBOCYTOPENIA; THROMBOSIS; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSTABLE ANGINA PECTORIS; VEIN THROMBOSIS; VENOUS THROMBOEMBOLISM;

EID: 77949676578     PISSN: 17512433     EISSN: None     Source Type: Journal    
DOI: 10.1586/ecp.09.55     Document Type: Review

References (38)

1. Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 133(6 Suppl.), 454S-545S (2008).
2. Warkentin TE, Greinacher A, Koster A, Lincoff AM. Treatment and prevention of heparin-induced thrombocytopenia: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 133(6 Suppl.), 340S-380S (2008).
3. Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 133, 160S-198S (2008).
4. Singer DE, Albers GW, Dalen JE et al. Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 133(6 Suppl.), 546S--592S (2008).
5. Hirsh J, Bauer KA, Donati MB, Gould M, Samama MM, Weitz JI. Parenteral anticoagulants: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 133(6 Suppl.), 141S-159S (2008).
6. Koopman MMW, Büller HR. Short- and long-acting synthetic pentasaccharides. J. Intern. Med. 254, 335-342 (2003).
7. Weitz JI, Hirsh J, Samama MM. New antithrombotic drugs: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 133(6 Suppl.), 234S-256S (2008).
8. Harenberg J, Wehling M. Current and future prospects for anticoagulant therapy: inhibitors of factor Xa and factor IIa. Semin. Thromb. Hemost. 34, 39-57 (2008).
9. Prandoni P, Tormene D, Perlati M, Brandolin B, Spiezia L. Idraparinux: review of its clinical efficacy and safety for prevention and treatment of thromboembolic disorders. Expert Opin. Investig. Drugs 17, 773-777 (2008).
10. Herbert JM, Hérault JP, Bernat A et al. Biochemical and pharmacological properties of SANORG 34006, a potent and long-acting synthetic pentasaccharide. Blood 91, 4197-4205 (1998).
11. Organon, Sanofi-Synthelabo. Idraparinux sodium. Drug Data Rep. 25, 332 (2003).
12. Van Amsterdam RGM, Burggraaf J, Borm GF et al. A Phase I multiple dose study to investigate the safety, tolerance and pharmacokinetics of 10 mg SC SanOrg34006 in male and female volunteers with a history of VTE, recently discharged from oral anticoagulant treatment. Clinical Trial Report on Protocol 64703. NV Organon. R&DRR NL0028967.
13. Faaij RA, Burggraaf J, Schoemaker RC et al. A Phase I single rising dose study to investigate the safety, tolerance and pharmacokinetics of subcutaneous SANORG 34006 in healthy male and female elderly volunteers. Thromb. Haemost. (Suppl.), (1999) (Abstract 1547).
14. Faaij RA, Burggraaf J, Schoemaker RC, et al. A Phase I single rising dose study to investigate the safety, tolerance and pharmacokinetics of SANORG 34006 in healthy young male volunteers. Thromb. Haemost. (Suppl.), (1999) (Abstract 2709).
15. Idraparinux sodium. Drug Data Rep. 25(4), 332 (2003).
16. PERSIST investigators. A novel longacting synthetic factor Xa inhibitor (SanOrg34006) to replace warfarin for secondary prevention in deep vein thrombosis. A Phase II evaluation. J. Thromb. Haemost. 2, 47-53 (2004).
17. Harenberg J, Jörg I, Vukojevic Y, Mikus G, Weiss C. Anticoagulant effects of idraparinux after termination of therapy for prevention of recurrent venous thromboembolism: observations from the van Gogh trials. Eur. J. Clin. Pharmacol. 64, 555-563 (2008).
18. Veyrat-Follet C, Vivier N, Trellu M, Dubruc C, Sanderink GJ. The pharmacokinetics of idraparinux, a long-acting indirect factor Xa inhibitor: population pharmacokinetic analysis from Phase III clinical trials. J. Thromb. Haemost. 7, 559-565 (2009).
19. Ma Q, Fareed J. Idraparinux sodium. Sanofi-Aventis. IDrugs 7(11), 1028-1034 (2004).
20. Bijsterveld NR, Vink R, Van Arken BE et al. Recombinant factor VIIa reverses the anticoagulant effect of the longacting pentasaccharide idraparinux in healthy volunteers. Br. J. Haematol. 124, 653-658 (2004).
21. The van Gogh Investigators. Idraparinux versus standard therapy for venous thromboembolic disease. N. Engl. J. Med. 357, 1094-1104 (2007).
22. The van Gogh Investigators. Extended prophylaxis of venous thromboembolism with idraparinux. N. Engl. J. Med. 357, 1105-1112 (2007).
23. Harenberg J, Weiss C, Mikus G, Joerg I, Vukojevic Y. Long elimination half life of idraparinux after termination of therapy explains bleeding in the van Gogh trials. J. Thromb. Haemost. 6, 890-892 (2008).
24. Hjelm R, Schedin-Weiss S. High affinity interaction between a synthetic, highly negatively charged pentasaccharide and a- or b-antithrombin is predominantly due to nonionic interactions. Biochemistry 46, 3378-3384 (2007).
25. The AMADEUS Investigators. Comparison of idraparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: a randomized, open-label, non-inferiority trial. Lancet 371, 315-321 (2008).
26. Benatar J, Stewart RA. Cutaneous blood-filled vesicles on idraparinux. Lancet 372, 1949 (2008).
27. Kang YS, Saito Y, Pardridge WM. Pharmacokinetics of [3H]biotin bound to different avidin analogues. J. Drug Target 3, 159-165 (1995).
28. Wilchek M, Bayer EA. The avidin-biotin complex in bioanalytical applications. Anal. Biochem. 171, 1-32 (1988).
29. Muus CJ, Azar HA. Application of immunochemistry to the diagnosis of human neoplasms in routine histologic sections. Diagn. Immunol. 4, 125-139 (1986).
30. Huntington JA, McCoy A, Belzar KJ, Pei XY, Gettins PG, Carrell RW. The conformational activation of antithrombin. A 2.85-A structure of a fluorescein derivative reveals an electrostatic link between the hinge and heparin binding regions. J. Biol. Chem. 275, 15377-15383 (2000).
31. Savi P, Herault JP, Duchaussoy P et al. Reversible biotinylated oligosaccharides: a new approach for a better management of anticoagulant therapy. J. Thromb. Haemost. 6, 1697-1706 (2008).
32. Burkhart KK, Britt AM. Reversal of toxicity using avidin-based hemoperfusion: a model system in rats using biotinylated melittin. Pharmacology 50, 307-312 (1995).
33. Stoldt HS, Aftab F, Chinol M et al. Pretargeting strategies for radioimmunoguided tumour localisation and therapy. Eur. J. Cancer 33, 186-192 (1997).
34. Trellu M, Perez Y, Ortiz J, Cheng S, Paty I. Bioequipotency of idraparinux and biotinylated idraparinux after single dose in healthy subjects. J. Thromb. Haemost. 5(Suppl. 2), PT678 (2007).
35. Buller HR, Destors JM, Gallus AS, Prins MH, Edward Raskob GE. Idrabiotaparinux, a biotinylated long-acting anticoagulant, in the treatment of deep venous thrombosis (EQUINOX study): safety, efficacy, and reversibility by avidin. Blood 112, 18 (2008).
36. Turpie AG. Fondaparinux: a factor Xa inhibitor for antithrombotic therapy. Expert Opin. Pharmacother. 5, 1373-1384 (2004).
37. De Kort M, Buijsman RC, Van Boeckel CA. Synthetic heparin derivatives as new anticoagulant drugs. Drug. Discov. Today 10, 769-779 (2005).
38. Connolly SJ, Ezekowitz MD, Salim Yusuf S et al. Dabigatran versus warfarin in patients with atrial fibrillation. N. Engl. J. Med. 361, 1-13 (2009).