Development of a dosage strategy in patients receiving enoxaparin by continuous intravenous infusion using modelling and simulation

British Journal of Clinical Pharmacology

Volumn 62, Issue 2, 2006, Pages 165-176

  Feng, Yan ^a   Green, Bruce ^b,c   Duffull, Stephen B ^b   Kane Gill, Sandra L ^a   Bobek, Mary B ^d   Bies, Robert R ^a,e  

^a UNIVERSITY OF PITTSBURGH   (United States)

^b UNIVERSITY OF QUEENSLAND   (Australia)

^c GEORGETOWN UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d NEW HANOVER REGIONAL MEDICAL CENTER   (United States)

^e UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

Author keywords

Creatinine clearance; Enoxaparin; NONMEM; Pharmacokinetics

Indexed keywords

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTICOAGULANTS; BODY WEIGHT; CREATININE; DRUG ADMINISTRATION SCHEDULE; ENOXAPARIN; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; INTENSIVE CARE; KIDNEY; LINEAR MODELS; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; RETROSPECTIVE STUDIES; THROMBOEMBOLISM; VENOUS THROMBOSIS;

EID: 33748267733     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2006.02650.x     Document Type: Article

References (48)

1. Hull RD, Raskob GE, Brant RF, Pineo GF, Elliott G, Stein PD, Gottschalk A, Valentine KA, Mah AF. Low-molecular-weight heparin vs. heparin in the treatment of patients with pulmonary embolism. American-Canadian Thrombosis Study Group. Arch Intern Med 2000; 160: 229-36.
2. Mismetti P, Laporte-Simitsidis S, Tardy B, Cucherat M, Buchmuller A, Juillard-Delsart D, Decousus H. Prevention of venous thromboembolism in internal medicine with unfractionated or low-molecular-weight heparins: a meta-analysis of randomised clinical trials. Thromb Haemost 2000; 83: 14-9.
3. Hull RD, Raskob GE, Pineo GF, Green D, Trowbridge AA, Elliott CG, Lerner RG, Hall J, Sparling T, Brettell HR, Norton J, Carter CJ, George R, Merli G, Ward J, Mayo W, Rosenbloom D, Brant R. Subcutaneous low-molecular-weight heparin compared with continuous intravenous heparin in the treatment of proximal-vein thrombosis. N Engl J Med 1992; 326: 975-82.
4. Gould MK, Dembitzer AD, Sanders GD, Garber AM. Low-molecular-weight heparins compared with unfractionated heparin for treatment of acute deep venous thrombosis. A cost-effectiveness analysis. Ann Intern Med 1999; 130: 789-99.
5. Antman EM, McCabe CH, Gurfinkel EP, Turpie AG, Bernink PJ, Salein D, Bayes De Luna A, Fox K, Lablanche JM, Radley D, Premmereur J, Braunwald E. Enoxaparin prevents death and cardiac ischemic events in unstable angina/non-Q-wave myocardial infarction. Results of the thrombolysis in myocardial infarction (TIMI) 11B trial. Circulation 1999; 100: 1593-601.
6. Cohen M, Demers C, Gurfinkel EP, Turpie AG, Fromell GJ, Goodman S, Langer A, Califf RM, Fox KA, Premmereur J, Bigonzi F. A comparison of low-molecular-weight heparin with unfractionated heparin for unstable coronary artery disease. Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events Study Group. N Engl J Med 1997; 337: 447-52.
7. Kaul S, Shah PK. Low molecular weight heparin in acute coronary syndrome: evidence for superior or equivalent efficacy compared with unfractionated heparin? J Am Coll Cardiol 2000; 35: 1699-712.
8. Bendetowicz AV, Beguin S, Caplain H, Hemker HC. Pharmacokinetics and pharmacodynamics of a low molecular weight heparin (enoxaparin) after subcutaneous injection, comparison with unfractionated heparin-a three way cross over study in human volunteers. Thromb Haemost 1994; 71: 305-13.
9. Greer IA. Prevention of venous thromboembolism in pregnancy. Best Pract Res Clin Haematol 2003; 16: 261-78.
10. Wong G, Giugliano R, Antman E. Use of low-molecular-weight heparins in the management of acute coronary artery syndromes and percutaneous coronary intervention. JAMA 2003; 289: 331-42.
11. Bergmann JF, Mouly S. Thromboprophylaxis in medical patients: focus on France. Semin Thromb Hemost 2002; 28 (Suppl. 3): 51-5.
12. Bruno R, Baille P, Retout S, Vivier N, Veyrat-Follet C, Sanderink GJ, Becker R, Antman EM. Population pharmacokinetics and pharmacodynamics of enoxaparin in unstable angina and non-ST-segment elevation myocardial infarction. Br J Clin Pharmacol 2003; 56: 407-14.
13. Green B, Duffull SB. Development of a dosing strategy for enoxaparin in obese patients. Br J Clin Pharmacol 2003; 56: 96-103.
14. 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.
15. Frydman A. Low-molecular-weight heparins: an overview of their pharmacodynamics, pharmacokinetics and metabolism in humans. Haemostasis 1996; 26 (Suppl. 2): 24-38.
16. Gerlach AT, Pickworth KK, Seth SK, Tanna SB, Barnes JF. Enoxaparin and bleeding complications: a review in patients with and without renal insufficiency. Pharmacotherapy 2000; 20: 771-5.
17. Hulot JS, Vantelon C, Urien S, Bouzamondo A, Mahe II, Ankri A, Montalescot G, Lechat P. Effect of renal function on the pharmacokinetics of enoxaparin and consequences on dose adjustment. Ther Drug Monit 2004; 26: 305-10.
18. Ma JM, Jackevicius CA, Yeo E. Anti-Xa monitoring of enoxaparin for acute coronary syndromes in patients with renal disease. Ann Pharmacother 2004; 38: 1576-81.
19. Brophy D, Wazny L, Gehr T, Cornstock T, Venitz J. The pharmacokinetics of subcutaneous enoxaparin in end-stage renal disease. Pharmacotherapy 2001; 21: 169-74.
20. Green B, Greenwood M, Saltissi D, Westhuyzen J, Kluver L, Rowell J, Atherton J. Dosing strategy for enoxaparin in patients with renal impairment presenting with acute coronary syndromes. Br J Clin Pharmacol 2005; 59: 281-90.
21. Power B, Forbes A, Heerden P, Ilett K. Pharmacokinetics of drugs used in critically III adults. Clin Pharmacokinet 1998; 34: 25-56.
22. Cook D, Attia J, Weaver B, McDonald E, Meade M, Crowther M. Venous thromboembolic disease: an observational study in medical-surgical intensive care unit patients. J Crit Care 2000; 15: 127-32.
23. Priglinger U, Delle Karth G, Geppert A, Joukhadar C, Graf S, Berger R, Hulsmann M, Spitzauer S, Pabinger I, Heinz G. Prophylactic anticoagulation with enoxaparin: is the subcutaneous route appropriate in the critically ill? Crit Care Med 2003; 31: 1405-9.
24. Haas CE, Nelsen JL, Raghavendran K, Mihalko W, Beres J, Ma Q, Forrest A. Pharmacokinetics and pharmacodynamics of enoxaparin in multiple trauma patients. J Trauma 2005; 59: 1336-43;discussion 1343-34.
25. Kane-Gill SL, Feng Y, Bobek MB, Bies RR, Pruchnicki MC, Dasta JF. Administration of enoxaparin by continuous infusion in a naturalistic setting: analysis of renal function and safety. J Clin Pharm Ther 2005; 30: 207-13.
26. Laposata M, Green D, Van Cott EM, Barrowcliffe TW, Goodnight SH, Sosolik RC. College of American Pathologists Conference XXXI on laboratory monitoring of anticoagulant therapy: the clinical use and laboratory monitoring of low-molecular-weight heparin, danaparoid, hirudin and related compounds, and argatroban. Arch Pathol Lab Med 1998; 122: 799-807.
27. Brater DC, Chennavasin P. Dosing regimens: determination of creatinine clearance as an index of renal function. In: Drug Use in Renal Disease, ed Brater DC, Boston: Adis Health Science Press 1983.
28. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31-41.
29. Beal B, Sheiner L. NONMEM User's Guide, Part I. San Francisco: University of California at San Francisco 1992.
30. Green B, Duffull SB. What is the best size descriptor to use for pharmacokinetic studies in the obese? Br J Clin Pharmacol 2004; 58: 119-33.
31. Gobburu JV, Lawrence J. Application of resampling techniques to estimate exact significance levels for covariate selection during nonlinear mixed effects model building: some inferences. Pharm Res 2002; 19: 92-8.
32. WFN Randomization Test.http://wfnsourceforgenet/wfnrthtm2003 (last accessed: September 2005.
33. Ette EI, Ludden TM. Population pharmacokinetic modeling: the importance of informative graphics. Pharm Res 1995; 12: 1845-55.
34. Kimko HC, Reele SS, Holford NH, Peck CC. Prediction of the outcome of a phase 3 clinical trial of an antischizophrenic agent (quetiapine fumarate) by simulation with a population pharmacokinetic and pharmacodynamic model. Clin Pharmacol Ther 2000; 68: 568-77.
35. Kimko HC, Duffull SB. Simulation for Designing Clinical Trials: A Pharmacokinetic-pharmacodynamic Modeling Perspective, Drugs & the Pharmaceutical Sciences Series. New York: Marcel Dekker 2002.
36. Holford NH, Kimko HC, Monteleone JP, Peck CC. Simulation of clinical trials. Annu Rev Pharmacol Toxicol 2000; 40: 209-34.
37. Collet JP, Montalescot G, Choussat R, Lison L, Ankri A. Enoxaparin in unstable angina patients with renal failure. Int J Cardiol 2001; 80: 81-2.
38. Montalescot G, Polle V, Collet JP, Leprince P, Bellanger A, Gandjbakhch I, Thomas D. Low molecular weight heparin after mechanical heart valve replacement. Circulation 2000; 101: 1083-6.
39. Collet JP, Montalescot G, Lison L, Choussat R, Ankri A, Drobinski G, Sotirov I, Thomas D. Percutaneous coronary intervention after subcutaneous enoxaparin pretreatment in patients with unstable angina pectoris. Circulation 2001; 103: 658-63.
40. Boneu B. Low molecular weight heparin therapy: is monitoring needed? Thromb Haemost 1994; 72: 330-4.
41. Abbate R, Gori AM, Farsi A, Attanasio M, Pepe G. Monitoring of low-molecular-weight heparins in cardiovascular disease. Am J Cardiol 1998; 82: 33L-36L.
42. FDA, Center for Drug Evaluation and Research. Pharmacokinetics in Patients with Impaired Renal Function - Study Design, Data Analysis, and Impact on Dosing and Labeling. Rockville, MD: Food and Drug Administration 1998.
43. K/DOQI. Clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Kindney Disease Outcome Quality Initiative. Am J Kidney Dis 2002; 39 (2 Suppl. 1): S1-246.
44. Feng Y, Bies R, Bobek M, Kane S. Population pharmacokinetics analysis of patients receiving enoxaparin by continuous intravenous infusion. Clin Pharmacol Therapeutics 2004; 75: 30.
45. Gisleskog PO, Karlsson MO, Beal SL. Use of prior information to stabilize a population data analysis. J Pharmacokinet Pharmacodyn 2002; 29: 473-505.
46. Bodenham A, Shelly MP, Park GR. The altered pharmacokinetics and pharmacodynamics of drugs commonly used in critically ill patients. Clin Pharmacokinet 1988; 14: 347-73.
47. Huet Y, Gouault-Heilmann M. Low molecular weight heparin fraction PK 10169: a new therapeutic means for anticoagulant therapy? Haemostasis 1986; 16: 165-72.
48. Huet Y, Gouault-Heilmann M, Contant G, Brun-Buisson C. Treatment of acute pulmonary embolism by a low molecular weight heparin fraction. A preliminary study. Intens Care Med1987;13: 126-30.