Changes in enoxaparin pharmacokinetics during pregnancy and implications for antithrombotic therapeutic strategy

Clinical Pharmacology and Therapeutics

Volumn 84, Issue 3, 2008, Pages 370-377

  Lebaudy, C ^a   Hulot, J S ^a   Amoura, Z ^a   Costedoat Chalumeau, N ^a   Serreau, R ^b   Ankri, A ^a   Conard, J ^c   Cornet, A ^a   Dommergues, M ^a   Piette, J C ^a   Lechat, P ^a  

^a PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^b HÔPITAL NECKER ENFANTS MALADES   (France)

^c HÔTEL DIEU   (France)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD CLOTTING FACTOR 10A INHIBITOR; ENOXAPARIN;

ADULT; AREA UNDER THE CURVE; ARTICLE; COMPARTMENT MODEL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; FEMALE; FIRST TRIMESTER PREGNANCY; FRANCE; HIGH RISK POPULATION; HUMAN; MAJOR CLINICAL STUDY; PARAMETER; POPULATION RESEARCH; PREGNANCY; PRIORITY JOURNAL; PUERPERIUM; SECOND TRIMESTER PREGNANCY; SIMULATION; THIRD TRIMESTER PREGNANCY; THROMBOEMBOLISM; WEIGHT CHANGE; WEIGHT GAIN;

ADULT; ANTICOAGULANTS; ENOXAPARIN; FEMALE; GESTATIONAL AGE; HUMANS; METABOLIC CLEARANCE RATE; POSTPARTUM PERIOD; PREGNANCY; PREGNANCY COMPLICATIONS, HEMATOLOGIC; TISSUE DISTRIBUTION; VENOUS THROMBOSIS;

EID: 49949084605     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2008.73     Document Type: Article

References (40)

1. Macklon, N.S. & Greer, I.A. Venous thromboembolic disease in obstetrics and gynaecology: the Scottish experience. Scott. Med. J. 41, 83-86 (1996).
2. Pabinger, I. & Schneider, B. Thrombotic risk in hereditary antithrombin III, protein C, or protein S deficiency. A cooperative, retrospective study. Gesellschaft fur Thrombose-und Hamostaseforschung (GTH) Study Group on natural inhibitors. Arterioscler. Thromb. Vasc. Biol. 16, 742-748 (1996).
3. Friederich, P.W. et al. Frequency of pregnancy-related venous thromboembolism in anticoagulant factor-deficient women: implications for prophylaxis. Ann. Intern. Med. 125, 955-960 (1996).
4. Conard, J., Horellou, M.H., Van Dreden, P., Lecompte, T. & Samama, M. Thrombosis and pregnancy in congenital deficiencies in AT III, protein C or protein S: study of 78 women. Thromb. Haemost. 63, 319-320 (1990).
5. Dulitzki, M., Pauzner, R., Langevitz, P., Pras, M., Many, A. & Schiff, E. Low-molecular-weight heparin during pregnancy and delivery: preliminary experience with 41 pregnancies. Obstet. Gynecol. 87, 380-383 (1996).
6. Nelson-Piercy, C., Letsky, E.A. & de Swiet, M. Low-molecular-weight heparin for obstetric thromboprophylaxis: experience of sixty-nine pregnancies in sixtyone women at high risk. Am. J. Obstet. Gynecol. 176, 1062-1068 (1997).
7. Brenner, B., Hoffman, R., Blumenfeld, Z., Weiner, Z. & Younis, J.S. Gestational outcome in thrombophilic women with recurrent pregnancy loss treated by enoxaparin. Thromb. Haemost. 83, 693-697 (2000).
8. Gris, J.C. et al. Low-molecular-weight heparin versus low-dose aspirin in women with one fetal loss and a constitutional thrombophilic disorder. Blood 103, 3695-3699 (2004).
9. Lepercq, J. et al. Venous thromboembolism during pregnancy: a retrospective study of enoxaparin safety in 624 pregnancies. BJOG 108, 1134-1140 (2001).
10. Greer, I.A. Thrombosis in pregnancy: maternal and fetal issues. Lancet 353, 1258-1265 (1999).
11. Chan, W.S., Anand, S. & Ginsberg, J.S. Anticoagulation of pregnant women with mechanical heart valves: a systematic review of the literature. Arch. Intern. Med. 160, 191-196 (2000).
12. Lee, L.H., Liauw, P.C. & Ng, A.S. Low molecular weight heparin for thromboprophylaxis during pregnancy in 2 patients with mechanical mitral valve replacement. Thromb. Haemost. 76, 628-630 (1996).
13. Mahesh, B., Evans, S. & Bryan, A.J. Failure of low molecular-weight heparin in the prevention of prosthetic mitral valve thrombosis during pregnancy: case report and a review of options for anticoagulation. J. Heart Valve Dis. 11, 745-750 (2002).
14. Fe, H. Physiological changes in the mother related to drug handling. In Drugs and Pregnancy (ed. Krauer, B.) P7-P15 (Academic Press, London, 1984).
15. Jeffries, W.S. & Bochner, F. The effect of pregnancy on drug pharmacokinetics. Med. J. Aust. 149, 675-677 (1988).
16. Hulot, J.S. et al. Effect of renal function on the pharmacokinetics of enoxaparin and consequences on dose adjustment. Ther. Drug Monit. 26, 305-310 (2004).
17. Hulot, J.S., Montalescot, G., Lechat, P., Collet, J.P., Ankri, A. & Urien, S. Dosing strategy in patients with renal failure receiving enoxaparin for the treatment of non-ST-segment elevation acute coronary syndrome. Clin. Pharmacol. Ther. 77, 542-552 (2005).
18. Bruno, R. et al. Population pharmacokinetics and pharmacodynamics of enoxaparin in unstable angina and non-ST-segment elevation myocardial infarction. Br. J. Clin. Pharmacol. 56, 407-414 (2003).
19. Brennand, J.E., Walker, I.D. & Greer, I.A. Anti-activated factor X profiles in pregnant women receiving antenatal thromboprophylaxis with enoxaparin. Acta. Haematol. 101, 53-55 (1999).
20. Casele, H.L., Laifer, S.A., Woelkers, D.A. & Venkataramanan, R. Changes in the pharmacokinetics of the low-molecular-weight heparin enoxaparin sodium during pregnancy. Am. J. Obstet. Gynecol. 181, 1113-1117 (1999).
21. Sanchez-Pena, P. et al. Anti-factor Xa kinetics after intravenous enoxaparin in patients undergoing percutaneous coronary intervention: a population model analysis. Br. J. Clin. Pharmacol. 60, 364-373 (2005).
22. Iorio, A. & Agnelli, G. Pharmacokinetic optimisation of the treatment of deep vein thrombosis. Clin. Pharmacokinet. 32, 145-172 (1997).
23. Collignon, F. et al. Comparison of the pharmacokinetic profiles of three low molecular mass heparins - dalteparin, enoxaparin and nadroparin - administered subcutaneously in healthy volunteers (doses for prevention of thromboembolism). Thromb. Haemost. 73, 630-640 (1995).
24. Dimitrakakis, C., Papageorgiou, P., Papageorgiou, I., Antzaklis, A., Sakarelou, N. & Michalas, S. Absence of transplacental passage of the low molecular weight heparin enoxaparin. Haemostasis 30, 243-248 (2000).
25. Omri, A., Delaloye, J.F., Andersen, H. & Bachmann, F. Low molecular weight heparin Novo (LHN-1) does not cross the placenta during the second trimester of pregnancy. Thromb. Haemost. 61, 55-56 (1989).
26. Udagawa, K. et al. Specific expression of PP5/TFPI2 mRNA by syncytiotrophoblasts in human placenta as revealed by in situ hybridization. Placenta 19, 217-223 (1998).
27. Sedlacek, H., Rehkopf, R. & Bohn, H. Immunofluorescence histological localization of human pregnancy and placental proteins in the placenta of man and monkey. Behring Inst. Mitt. 91-95 (1976).
28. Obiekwe, B., Pendlebury, D.J., Gordeon, Y.B., Grudzinskas, J.G., Chard, T. & Bohn, H. The radioimmunoassay of placental protein 5 and circulating levels in maternal blood in the third trimester of normal pregnancy. Clin. Chim. Acta 95, 509-516 (1979).
29. Takayama, M. et al. Circulating levels of placental protein 5 in normal and abnormal pregnancies. Gynecol. Obstet. Invest. 16, 13-26 (1983).
30. Jones, G.R., Davey, M.W., Sinosich, M. & Grudzinskas, J.G. Specific interaction between placental protein 5 and heparin. Clin. Chim. Acta 110, 65-70 (1981).
31. Hunter, S. & Robson, S. Adaptation of the maternal heart in pregnancy. Br. Heart J. 68, 540-543 (1992).
32. Aharon, A., Lanir, N., Drugan, A. & Brenner, B. Placental TFPI is decreased in gestational vascular complications and can be restored by maternal enoxaparin treatment. J. Thromb. Haemost. 3, 2355-2357 (2005).
33. Lanir, N., Aharon, A. & Brenner, B. Haemostatic mechanisms in human placenta. Best Pract. Res. Clin. Haematol. 16, 183-195 (2003).
34. Rowan, J.A., McLintock, C., Taylor, R.S. & North, R.A. Prophylactic and therapeutic enoxaparin during pregnancy: indications, outcomes and monitoring. Aust. N. Z. J. Obstet. Gynaecol. 43, 123-128 (2003).
35. Toglia, M.R. & Weg, J.G. Venous thromboembolism during pregnancy. N. Engl. J. Med. 335, 108-114 (1996).
36. Bates, S.M., Greer, I.A., Hirsh, J. & Ginsberg, J.S. Use of antithrombotic agents during pregnancy: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 126(suppl. 3), 627S-644S (2004).
37. Dawes, J., Bara, L., Billaud, E. & Samama, M. Relationship between biological activity and concentration of a low-molecular-weight heparin (PK 10169) and unfractionated heparin after intravenous and subcutaneous administration. Haemostasis 16, 116-122 (1986).
38. Whiting, B., Kelman, A.W. & Grevel, J. Population pharmacokinetics. Theory and clinical application. Clin. Pharmacokinet. 11, 387-401 (1986).
39. Beal, S.L., NONMEM Project Group. NONMEM User's Guide. University of California at San Francisco, 1998.
40. Parke, J., Holford, N.H. & Charles, B.G. A procedure for generating bootstrap samples for the validation of nonlinear mixed-effects population models. Comput. Methods Programs Biomed. 59, 19-29 (1999).