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A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: The Randomized, phase II study to Evaluate the sAfety and.

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Presentation on theme: "A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: The Randomized, phase II study to Evaluate the sAfety and."— Presentation transcript:

1 A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: The Randomized, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dabIGatran etexilate in patients after heart valve replacemeNt (RE-ALIGN)  Frans Van de Werf, MD, Martina Brueckmann, MD, Stuart J. Connolly, MD, Jeffrey Friedman, MD, Christopher B. Granger, MD, Sebastian Härtter, PhD, Ruth Harper, MD, Arie Pieter Kappetein, MD, Thorsten Lehr, PhD, Michael J. Mack, MD, Herbert Noack, PhD, John W. Eikelboom, MD  American Heart Journal  Volume 163, Issue 6, Pages e1 (June 2012) DOI: /j.ahj Copyright © 2012 Mosby, Inc. Terms and Conditions

2 Figure 1 Model-predicted probability of ischemic stroke and systemic embolic event versus trough plasma concentration of total dabigatran by age in atrial fibrillation subjects receiving either dabigatran etexilate 110 mg twice a day or dabigatran etexilate 150 mg twice a day in the RELY study.20 American Heart Journal  , e1DOI: ( /j.ahj ) Copyright © 2012 Mosby, Inc. Terms and Conditions

3 Figure 2 A, Median concentration-time profiles at steady state of each of the virtual patients with their respective target dose. A is depicting the median concentration-time profiles at steady state of each of the virtual patients with their respective target dose. In addition, the 80% prediction interval (10th to 90th percentiles) of the typical RE-LY patient receiving dabigatran 150 mg twice a day (reference exposure profile) is provided as shaded area. The simulation revealed that the median profiles are similar and overlap widely. All median profiles are within the 80% prediction interval, indicating a similar exposure. B, 80% prediction intervals (10th to 90th percentiles) of dabigatran trough concentrations at steady state in RE-ALIGN in comparison with observed concentrations in RE-LY. American Heart Journal  , e1DOI: ( /j.ahj ) Copyright © 2012 Mosby, Inc. Terms and Conditions

4 Figure 3 Study plan for patients who got an aortic or mitral bileaflet valve during index hospitalization (A, recent surgery group) and patients who got a mechanical bileaflet valve >3 months before randomization (B, remote surgery group). A, RE-ALIGN trial design—recent surgery group. B, RE-ALIGN trial design—remote surgery group. American Heart Journal  , e1DOI: ( /j.ahj ) Copyright © 2012 Mosby, Inc. Terms and Conditions

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