Erratum to: An adaptive-design dose-ranging study of PD 0348292, an oral factor Xa inhibitor, for thromboprophylaxis after total knee replacement surgery (Journal of Thrombosis and Haemostasis, (2013), 11, 8, (1503-1510), 10.1111/jth.12328);An adaptive-design dose-ranging study of PD 0348292, an oral factor Xa inhibitor, for thromboprophylaxis after total knee replacement surgery

Journal of Thrombosis and Haemostasis

Volumn 11, Issue 8, 2013, Pages 1503-1510

  Cohen, A T ^a   Boyd, R A ^b   Mandema, J W ^c   Dicarlo, L ^d   Pak, R ^b  

^a KING S COLLEGE HOSPITAL   (United Kingdom)

^b PFIZER INC   (United States)

^c Quantitative Solutions Inc   (United States)

^d Proteus Industries Inc   (United States)

Author keywords

Anticoagulants; Dose Response Relationship; Drug; Research design; Total knee replacement; Venous thromboembolism

Indexed keywords

ENOXAPARIN; ERIBAXABAN;

ARTICLE; BLEEDING; CONTROLLED STUDY; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; LUNG VENTILATION PERFUSION RATIO; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PHLEBOGRAPHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STUDY DESIGN; TOTAL KNEE REPLACEMENT; VENOUS THROMBOEMBOLISM;

ANTICOAGULANTS; DOSE RESPONSE RELATIONSHIP; DRUG; RESEARCH DESIGN; TOTAL KNEE REPLACEMENT; VENOUS THROMBOEMBOLISM;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; ARTHROPLASTY, REPLACEMENT, KNEE; COMPUTER SIMULATION; DOSE-RESPONSE RELATIONSHIP, DRUG; ENOXAPARIN; FACTOR XA; FEMALE; HUMANS; MALE; MIDDLE AGED; PROBABILITY; PYRIDONES; PYRROLIDINES; THROMBOEMBOLISM; TREATMENT OUTCOME;

EID: 84881564761     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/jth.14333     Document Type: Erratum

References (18)

1. Goldhaber SZ. Medical Progress: pulmonary embolism. N Engl J Med 1998; 339: 93-104.
2. Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW; Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133: 381S-453S.
3. Gould WR, Leadley RJ. Recent advances in the discovery and development of direct coagulation factor Xa inhibitors. Curr Pharm Des 2003; 9: 2337-47.
4. Turpie AG. Oral, direct factor Xa inhibitors in development for the prevention and treatment of thromboembolic diseases. Arterioscler Thromb Vasc Biol 2007; 27: 1238-47.
5. Kohrt JT, Bigge CF, Bryant JW, Casimiro-Garcia A, Chi L, Cody WL, Dahring T, Dudley DA, Filipski KJ, Haarer S, Heemstra R, Janiczek N, Narasimhan L, McClanahan T, Peterson JT, Sahasrabudhe V, Schaum R, van Huis CA, Welch KM, Zhang E, et al. The discovery of (2R, 4R)-N(4-chlorophenyl)-4-methoxypyrrolidine-1, 2-dicarboxamide (PD 0348292), an orally efficacious factor Xa inhibitor. Chem Biol Drug Des 2007; 70: 100-12.
6. Eriksson BI, Quinlan DJ, Weitz JI. Comparative pharmacodynamics and pharmacokinetics of oral direct thrombin and factor Xa inhibitors in development. Clin Pharmacokinet 2009; 48: 1-22.
7. Xuan D, Boyd R, DiCarlo L. Population pharmacokinetics and pharmacodynamics of PD 0348292, an oral, direct factor Xa inhibitor, in healthy subjects. Clin Pharmacol Ther 2010; 87: S54.
8. Schulman S, Kearon C; on behalf of the subcommittee on control of anticoagulation of the scientific and standardization committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 3: 692-4.
9. Boyd R, Mandema J, McBride S, Spino C, Abel R, Gillespie W, Hassan A, DeCarlo L. Modeling and simulation facilitated design of an adaptive phase 2 dose-finding study for PD 0348292, a novel FXa inhibitor. Clin Pharmacol Ther 2008; 83: S61.
10. Eriksson BI, Borris L, Dahl OE, Haas S, Huisman MV, Kakkar AK, Misselwitz F, Kalebo P; for the ODIXa-HIP Study Investigators. Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement. J Thromb Haemost 2006; 4: 121-8.
11. Lassen MR, Davidson BL, Gallus A, Pineo G, Ansell J, Deitchman D. A phase II randomized, double blind, five-arm, parallel group, dose-response study of a new oral directly-acting factor Xa inhibitor, razaxaban, for the prevention of deep vein thrombosis in knee replacement surgery. Blood 2003; 102: 41.
12. Swaminathan A, Frost C, Knabb R, Bai SA, Kornhauser D, Mosqueda-Garcia R. Pharmacokinetic and pharmacodynamic characteristics in healthy volunteers of razaxaban, an orally-active, potent, selective inhibitor of Factor Xa. Clin Pharmacol Ther 2004; 75: P6.
13. Kubitza D, Becka M, Wensing G, Voith B, Zuehlsdorf M. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939 - an oral, direct Factor Xa inhibitor - after multiple dosing in healthy male subjects. Eur J Clin Pharmacol 2005; 61: 873-80.
14. Bauer KA, Eriksson BI, Lassen MR, Turpie AGG. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after elective major knee surgery. N Engl J Med 2001; 345: 1305-10.
15. Heit JA, Colwell CW, Francis CW, Ginsberg JS, Berkowitz SD, Whipple J, Peters G; for the AstraZeneca Arthroplasty Study Group. Comparison of the oral direct thrombin inhibitor ximelagatran with enoxaparin as prophylaxis against venous thromboembolism after total knee replacement: a phase 2 dose-finding study. Arch Intern Med 2001; 161: 2215-21.
16. Turpie AGG, Fisher WD, Bauer KA, Kwong LM, Irwin MW, Kalebo P, Misselwitz F, Gent M; for the ODIXa-KNEE Study Group. BAY 59-7939: an oral, direct Factor Xa inhibitor for the prevention of venous thromboembolism in patients after total knee replacement. A phase II dose-ranging study. J Thromb Haemost 2005; 3: 2479-86.
17. Lassen MR, Davidson BL, Gallus A, Pineo G, Ansell J, Deitchman D. The efficacy and safety of apixaban, an oral, direct factor Xa inhibitor, as thromboprophylaxis in patients following total knee replacement. J Thromb Haemost 2007; 5: 2368-75.
18. Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Portman RJ. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med 2009; 361: 594-604.