Population pharmacokinetics of enoxaparin in infants, children and adolescents during secondary thromboembolic prophylaxis: A cohort study

Journal of Thrombosis and Haemostasis

Volumn 8, Issue 9, 2010, Pages 1950-1958

  Trame, M N ^a,b   Mitchell, L ^c   Krumpel A ^b   Male, C ^d   Hempel, G ^a,b   Nowak Gottl U ^b  

^a UNIVERSITY OF MÜNSTER   (Germany)

^b UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^c STOLLERY CHILDREN S HOSPITAL   (Canada)

^d MEDICAL UNIVERSITY OF VIENNA   (Austria)

Author keywords

Anti factor Xa activity; Children; Enoxaparin; Population pharmacokinetics; Therapeutic drug monitoring; Venous thromboembolism

Indexed keywords

D DIMER; ENOXAPARIN;

ADOLESCENT; ADOLESCENT DISEASE; ADULT; ARTICLE; BLEEDING; BLOOD SAMPLING; CHILD; CHILDHOOD DISEASE; CLINICAL TRIAL; COHORT ANALYSIS; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; FEMALE; HUMAN; INFANT; INFANT DISEASE; MAJOR CLINICAL STUDY; MALE; OPEN STUDY; PARTIAL THROMBOPLASTIN TIME; PATIENT COMPLIANCE; PHARMACOKINETICS; POSTTHROMBOSIS SYNDROME; PRESCHOOL CHILD; PRIORITY JOURNAL; RECURRENT DISEASE; SCHOOL CHILD; SECONDARY PREVENTION; THROMBOEMBOLISM; VENOUS THROMBOEMBOLISM;

ADOLESCENT; ANTICOAGULANTS; BODY WEIGHT; CHILD; CHILD, PRESCHOOL; COHORT STUDIES; ENOXAPARIN; FACTOR XA; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFANT; KINETICS; MALE; THROMBOEMBOLISM; TIME FACTORS; TREATMENT OUTCOME;

EID: 77956470683     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/j.1538-7836.2010.03964.x     Document Type: Article

References (35)

1. Andrew M. Developmental hemostasis: relevance to thromboembolic complications in pediatric patients. Thromb Haemost 1995, 74:415-25.
2. Monagle P, Adams M, Mahoney M, Ali K, Barnard D, Bernstein M, Brisson L, David M, Desai S, Scully MF, Halton J, Israels S, Jardine L, Leaker M, McCusker P, Silva M, Wu J, Anderson R, Andrew M, Massicotte MP. Outcome of pediatric thromboembolic disease: a report from the Canadian Childhood Thrombophilia Registry. Pediatr Res 2000, 47:763-6.
3. Monagle P, Michelson AD, Bovill E, Andrew M. Antithrombotic therapy in children. Chest 2001, 119:344S-70S.
4. Punzalan RC, Hillery CA, Montgomery RR, Scott CA, Gill JC. Low-molecular-weight heparin in thrombotic disease in children and adolescents. J Pediatr Hematol Oncol 2000, 22:137-42.
5. Dix D, Andrew M, Marzinotto V, Charpentier K, Bridge S, Monagle P, deVeber G, Leaker M, Chan AK, Massicotte MP. The use of low molecular weight heparin in pediatric patients: a prospective cohort study. J Pediatr 2000, 136:439-45.
6. Hofmann S, Knoefler R, Lorenz N, Siegert G, Wendisch J, Mueller D, Taut-Sack H, Dinger J, Kabus M. Clinical experiences with low-molecular weight heparins in pediatric patients. Thromb Res 2001, 103:345-53.
7. Streif W, Goebel G, Chan AK, Massicotte MP. Use of low molecular mass heparin (enoxaparin) in newborn infants: a prospective cohort study of 62 patients. Arch Dis Child Fetal Neonatal Ed 2003, 88:F365-70.
8. Massicotte P, Julian JA, Gent M, Shields K, Marzinotto V, Szechtman B, Andrew M. An open-label randomized controlled trial of low molecular weight heparin compared to heparin and coumadin for the treatment of venous thromboembolic events in children: the REVIVE trial. Thromb Res 2003, 109:85-92.
9. Merkel N, Gunther G, Schobess R. Long-term treatment of thrombosis with enoxaparin in pediatric and adolescent patients. Acta Haematol 2006, 115:230-6.
10. Schobess R, During C, Bidlingmaier C, Heinecke A, Merkel N, Nowak-Gottl U. Long-term safety and efficacy data on childhood venous thrombosis treated with a low molecular weight heparin: an open-label pilot study of once-daily versus twice-daily enoxaparin administration. Haematologica 2006, 91:1701-4.
11. O'Brien SH, Lee H, Ritchey AK. Once-daily enoxaparin in pediatric thromboembolism: a dose finding and pharmacodynamics/pharmacokinetics study. J Thromb Haemost 2007, 5:1985-7.
12. Crary SE, Van Orden H, Journeycake JM. Experience with intravenous enoxaparin in critically ill infants and children. Pediatr Crit Care Med 2008, 9:647-9.
13. Stine KC, Saylors RL, Saccente CS, Becton DL. Treatment of deep vein thrombosis with enoxaparin in pediatric cancer patients receiving chemotherapy. Clin Appl Thromb Hemost 2007, 13:161-5.
14. Bauman ME, Belletrutti MJ, Bajzar L, Black KL, Kuhle S, Bauman ML, Patricia MM. Evaluation of enoxaparin dosing requirements in infants and children. Better dosing to achieve therapeutic levels. Thromb Haemost 2009, 101:86-92.
15. van Dongen CJ, MacGillavry MR, Prins MH. Once versus twice daily LMWH for the initial treatment of venous thromboembolism. Cochrane Database Syst Rev 2005, CD003074.
16. Hirsh J, Levine MN. Low molecular weight heparin. Blood 1992, 79:1-17.
17. Perry DJ. Treating venous thromboembolism: enoxaparin. Hosp Med 2001, 62:757-64.
18. Newall F, Barnes C, Ignjatovic V, Monagle P. Heparin-induced thrombocytopenia in children. J Paediatr Child Health 2003, 39:289-92.
19. Merli G, Spiro TE, Olsson CG, Abildgaard U, Davidson BL, Eldor A, Elias D, Grigg A, Musset D, Rodgers GM, Trowbridge AA, Yusen RD, Zawilska K. Subcutaneous enoxaparin once or twice daily compared with intravenous unfractionated heparin for treatment of venous thromboembolic disease. Ann Intern Med 2001, 134:191-202.
20. Couturaud F, Julian JA, Kearon C. Low molecular weight heparin administered once versus twice daily in patients with venous thromboembolism: a meta-analysis. Thromb Haemost 2001, 86:980-4.
21. Nowak-Gottl U, Kosch A, Schlegel N. Thromboembolism in newborns, infants and children. Thromb Haemost 2001, 86:464-74.
22. Sanderink GJ, Le Liboux A, Jariwala N, Harding N, Ozoux ML, Shukla U, Montay G, Boutouyrie B, Miro A. The pharmacokinetics and pharmacodynamics of enoxaparin in obese volunteers. Clin Pharmacol Ther 2002, 72:308-18.
23. Hirsh J, Raschke R. Heparin and low-molecular-weight heparin: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004, 126:188S-203S.
24. Ignjatovic V, Summerhayes R, Gan A, Than J, Chan A, Cochrane A, Bennett M, Horton S, Shann F, Lane G, Ross-Smith M, Monagle P. Monitoring Unfractionated Heparin (UFH) therapy: which Anti-Factor Xa assay is appropriate? Thromb Res 2007, 120:347-51.
25. Greaves M. Limitations of the laboratory monitoring of heparin therapy. Scientific and Standardization Committee Communications: on behalf of the Control of Anticoagulation Subcommittee of the Scientific and Standardization Committee of the International Society of Thrombosis and Haemostasis. Thromb Haemost 2002, 87:163-4.
26. Beal SL, Sheiner BL, Boeckmann A. NONMEM user's guide 1999, San Francisco, Calif, University of California
27. Ette EI, Ludden TM. Population pharmacokinetic modeling: the importance of informative graphics. Pharm Res 1995, 12:1845-55.
28. Mandema JW, Verotta D, Sheiner LB. Building population pharmacokinetic--pharmacodynamic models I. Models for covariate effects. J Pharmacokinet Biopharm 1992, 20:511-28.
29. Anderson BJ, McKee AD, Holford NH. Size, myths and the clinical pharmacokinetics of analgesia in paediatric patients. Clin Pharmacokinet 1997, 33:313-27.
30. Post TM, Freijer JI, Ploeger BA, Danhof M. Extensions to the visual predictive check to facilitate model performance evaluation. J Pharmacokinet Pharmacodyn 2008, 35:185-202.
31. Fareed J, Hoppensteadt D, Walenga J, Iqbal O, Ma Q, Jeske W, Sheikh T. Pharmacodynamic and pharmacokinetic properties of enoxaparin: implications for clinical practice. Clin Pharmacokinet 2003, 42:1043-57.
32. Barrett JS, Gibiansky E, Hull RD, Planes A, Pentikis H, Hainer JW, Hua TA, Gastonguay M. Population pharmacodynamics in patients receiving tinzaparin for the prevention and treatment of deep vein thrombosis. Int J Clin Pharmacol Ther 2001, 39:431-46.
33. Fareed J, Walenga JM, Hoppensteadt DA, Emanuele RM. Laboratory studies on the intravenous and subcutaneous administration of PK 10169 in man. Haemostasis 1986, 16:123-38.
34. Frydman AM, Bara L, Le Roux Y, Woler M, Chauliac F, Samama MM. The antithrombotic activity and pharmacokinetics of enoxaparine, a low molecular weight heparin, in humans given single subcutaneous doses of 20 to 80 mg. J Clin Pharmacol 1988, 28:609-18.
35. Harenberg J, Huhle G, Piazolo L, Giese C, Heene DL. Long-term anticoagulation of outpatients with adverse events to oral anticoagulants using low-molecular-weight heparin. Semin Thromb Hemost 1997, 23:167-72.