The effect of recombinant factor VIIa (NovoSeven(TM)) in healthy volunteers receiving acenocoumarol to an International Normalized Ratio above 2.0

Blood Coagulation and Fibrinolysis

Volumn 9, Issue 8, 1998, Pages 741-748

  Erhardtsen, Elisabeth ^a   Nony, P ^b   Dechavanne, M ^b   Ffrench, P ^b   Boissel, J P ^b   Hedner, U ^c  

^a NOVO NORDISK A S   (Denmark)

^b Service de Pharmacologie Clinique   (France)

^c LUND UNIVERSITY HOSPITAL   (Sweden)

Author keywords

Coagulation factor VIIa; Oral anticoagulant therapy; Warfarin

Indexed keywords

ACENOCOUMAROL; ANTICOAGULANT AGENT; BLOOD CLOTTING FACTOR 7; PLACEBO; RECOMBINANT BLOOD CLOTTING FACTOR 7A;

ADULT; ANTICOAGULANT THERAPY; ARTICLE; BLEEDING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFECT; HEMATOLOGICAL PARAMETERS; HEMOSTASIS; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; PROTHROMBIN TIME; RANDOMIZED CONTROLLED TRIAL; THROMBOEMBOLISM;

EID: 0032465250     PISSN: 09575235     EISSN: None     Source Type: Journal    
DOI: 10.1097/00001721-199811000-00003     Document Type: Article

References (37)

1. Hull R, Delmore T, Genton E, Hirsh J, Gent M, Sackett D, et al. Warfarin sodium versus low-dose heparin in the long-term treatment of venous thrombosis. N Engl J Med 1979; 301: 855-858.
2. Hirsh J. Oral anticoagulant drugs. TV Engl J Med 1991; 324: 1865-1875.
3. Ansell JE. Oral anticoagulant therapy - 50 years later. Arch Intern Med 1993; 153: 586-596.
4. Talstad I. Which coagulation factors interfere with the one-stage prothrombin time? Haemostasis 1993; 23: 19-25.
5. Kyrle PA, Brockmeier J, Weltermann A, Eichinger S, Speiser W, Lechner K, et al. Inhibition rather than enhancement of hemostatic system activation during initiation of oral anticoagulant treatment. Thromb Haemost 1997; 77: 685-689.
6. Kearon C, Hirsh J. Management of anticoagulation before and after elective surgery. N Engl J Med 1997; 336: 1506-1511.
7. Gitter MJ, Jaeger TM, Petterson TM, Gersh BJ, Silverstein MD. Bleeding and thromboembolism during anticoagulant therapy: a population-based study in Rochester, Minnesota. Mayo Clin Proc 1995; 70: 725-733.
8. Mariani G, Mazzucconi MG. Factor VII congenital deficiency. Clinical picture and classification of the variants. Haemostasis 1983; 13: 169-177.
9. Takahashi H, Tatewaki W, Wada K, Yoshikawa A, Shibata A. Thrombin and plasmin generation in patients with liver disease. Am J Hematol 1989; 32: 30-35.
10. Vukovich T, Teufelsbauer H, Fritzer M, Kreuzer S, Knoflach P. Hemostasis activation in patients with liver-cirrhosis. Thromb Research 1995; 77: 271-278.
11. Glazer S, Hedner U, Falch JF. Pathologic inhibitors. Management with factor VIIa. In: Green D (editor): Anticoagulants - Physiologic, pathologic and pharmacologic. Boca Raton: CRC Press Inc.; 1994. pp. 131-141.
12. Lusher JM. Recombinant factor VIIa in the treatment of internal bleeding in patients with factor VIII and IX inhibitors. Haemostasis 1996; 26 (suppl 1): 124-130.
13. Rice KM, Savidge GF. NovoSeven in central nervous system bleeds. Haemostasis 1996; 26 (suppl 1): 131-134.
14. Ingerslev J, Friedman D, Gastineau D, Gilchrist G, Johnsson H, Lucas G, et al. Major surgery in hemophiliac patients with inhibitors using recombinant factor VIIa. Haemostasis 1996; 26 (suppl 1): 118-123.
15. Bech RM, Andersen PM, Glazer S, Hedner U. Recombinant factor VIIa for the treatment of congenital factor VII deficient patients. Thromb Haemost 1995; 73: 983A.
16. Bernstein DE, Glazer S, Jeffers LJ, Squiban P, Reddy KR, Roach K, et al. Recombinant VIIa (rFVIIa) in the treatment of prolonged prothrombin time (PT) in cirrhotics. Gastroenterology 1997; 113: 1930-1937.
17. Diness V, Lund-Hansen T, Hedner U. Effect of recombinant human FVIIa on warfarin-induced bleeding in rats. Thromb Res 1990; 59: 921-929.
18. Thim L, Bjoern S, Christensen M, Nicolaisen EM, Lund-Hansen T, Pedersen AH, et al. Amino acid sequence and posttranslational modifications of human factor VIIa from plasma and transfected baby hamster kidney cells. Biochemistry 1988; 27: 7785-7793.
19. Hansen LL, Nielsen FE, Hedner U. Validation of method for determination of recombinant FVIIa coagulant activity in plasma using a one-stage clotting assay. Thromb Haemost 1993; 69: 865.
20. Stenflo J. Vitamin K and the biosynthesis of prothrombin. IV. Isolation of peptides containing prosthetic groups from normal prothrombin and the corresponding peptides from dicoumarol-induced prothrombin. J Biol Chem 1974; 249: 5527-5535.
21. Nelsestuen GL, Zytkovicz TH, Howard JB. The mode of action of vitamin K. Identification of gamma-carboxyglutamic acid as a component of prothrombin. J Biol Chem 1974; 249: 6347-6350.
22. Hay SM, Allen MJ, Barnes MR. Acute compartment syndromes resulting from anticoagulant treatment. BMJ 1992; 305: 1474-1475.
23. Landefeld CS, Goldman L. Major bleeding in outpatients treated with warfarin: incidence and prediction by factors known at the start of outpatient therapy. Am J Med 1989; 87: 144-152.
24. Hylek EM, Singer DE. Risk-factors for intracranial hemorrhage in outpatients taking warfarin. Ann Intern Med 1994; 120: 897-902.
25. Ratnoff OD. Disseminated intravascular coagulation. In: Ratnoff OD, Forbes CD (editors): Disorders of haemostasis.Orlando, Florida: Grumed Stratton, Inc.; 1984. p. 289-319.
26. Mackie MJ, Douglas AS. Drug-induced disorders of coagulation. In: Ratnoff OD, Forbes CD (editors): Disorders of hemostasis. Orlando, Florida: Grumed Stratton, Inc.; 1984. p. 485-510.
27. Forbes CD. Clinical aspects of the hemophiliacs and their treatment. In: Ratnoff OD, Forbes CD (editors): Disorders of hemostasis. Orlando, Florida: Grune & Stratton, Inc.; 1984 p. 117-239.
28. Ingerslev J, Knudsen L, Hvid I, Tange MR, Fredberg U, Sneppen O. Use of recombinant factor VII in surgery in factor VII deficient patients. Haemophilia 1997; 3: 215-218.
29. Wilhelmsen L, Svardsudd K, Korsan-Bengtsen K, Larsson B, Welin L, Tibblin G. Fibrinogen as a risk factor for stroke and myocardial infarction. N Engl J Med 1984; 311: 501-505.
30. Meade TW, Stirling Y, Thompson SG, Vickers MV, Woolf L, Ajdukiewicz AB, et al. An international and interregional comparison of haemostatic variables in the study of ischaemic heart disease. Report of a working group. Int J Epidemiol 1986; 15: 331-336.
31. Kannel WB, Wolf PA, Castelli WP, D'Agostino RB. Fibrinogen and risk of cardiovascular disease. The Framingham Study. JAMA 1987; 258: 1183-1186.
32. Ishikawa S, Kario K, Nago N, Kayaba K, Hiraoka J, Matsuo H, et al. Factor VII and fibrinogen levels examined by age, sex, and other atherosclerotic risk factors in a Japanese population. Thromb Haemost 1997; 77: 890-893.
33. Green D, Chamberlain MA, Ruth KJ, Folsom AR, Liu K. Factor-VII, cholesterol, and triglycerides - the cardiac study. Arterioscler Thromb Vasc Biol 1997; 17: 51-55.
34. Silveira A, Karpe F, Johnsson H, Bauer KA, Hamsten A. In-vivo demonstration in humans that large postprandial triglyceride-rich lipoproteins activate coagulation-factor-VII through the intrinsic coagulation pathway. Arterioscler Thromb Vasc Biol 1996; 16: 1333-1339.
35. Kapur R, Hoffman CJ, Bhushan V, Hultin MB. Postprandial elevation of activated factor-VII in young adults. Arterioscler Thromb Vasc Biol 1996; 16: 1327-1332.
36. Miller GJ, Bauer KA, Barzegar S, Toley A, Mitchell JP, Cooper JA, et al. The effects of quality and timing of venipuncture on markers of blood coagulation in healthy middle-aged men. Thromb Haemost 1995; 73: 82-86.
37. Monroe DM, Hoffman M, Oliver JA, Roberts HR. Platelet activity of high-dose factor VIIa independent of tissue factors. Br J Haematol 1998; 99:542-547.