Thursday, September 09, 2010
Dabigatran AF atrium fibrillation. anticoagulans
Summary and Comment
More Good News About Dabigatran
Dabigatran's advantages over warfarin are increased at centers with poor control of international normalized ratio in warfarin therapy.
The race is on to find an alternative to warfarin, which is currently the most effective agent for preventing stroke in patients with atrial fibrillation (AF) but has a narrow therapeutic range that is difficult and inconvenient to sustain. A new agent, dabigatran, has recently demonstrated noninferiority to warfarin in >18,000 patients with documented AF and at least one other risk factor for stroke who participated in RE-LY, a manufacturer-funded international trial (JW Cardiol Sep 1 2009). In a prespecified substudy, the RE-LY investigators divided the trial centers into quartiles by the average time participants on warfarin had international normalized ratios (INRs) within therapeutic range, and compared rates of the primary and secondary endpoints in the warfarin and dabigatran groups in each quartile.
Of 5791 participants assigned to warfarin, those treated at centers with higher rates of therapeutic INR time had lower risks for the composite endpoint of stroke and systemic embolism, major bleeding, and mortality than those treated at centers with lower rates of therapeutic INR time. At centers with lower rates of therapeutic INR time, dabigatran was associated with significant reductions in the composite endpoint of cardiovascular events and total mortality, as compared with warfarin.
Comment: In this study, poor control of INR in patients assigned to warfarin amplified the relative benefits of dabigatran. One would expect that patients who are enrolled in clinical trials would achieve better INR rates than patients who are not. Therefore, these findings suggest that in "real-life" clinical situations, the advantages of dabigatran over warfarin could be even greater than they were in the RE-LY trial.
— Mark S. Link, MD
Published in Journal Watch Cardiology August 30, 2010
More Good News About Dabigatran
Dabigatran's advantages over warfarin are increased at centers with poor control of international normalized ratio in warfarin therapy.
The race is on to find an alternative to warfarin, which is currently the most effective agent for preventing stroke in patients with atrial fibrillation (AF) but has a narrow therapeutic range that is difficult and inconvenient to sustain. A new agent, dabigatran, has recently demonstrated noninferiority to warfarin in >18,000 patients with documented AF and at least one other risk factor for stroke who participated in RE-LY, a manufacturer-funded international trial (JW Cardiol Sep 1 2009). In a prespecified substudy, the RE-LY investigators divided the trial centers into quartiles by the average time participants on warfarin had international normalized ratios (INRs) within therapeutic range, and compared rates of the primary and secondary endpoints in the warfarin and dabigatran groups in each quartile.
Of 5791 participants assigned to warfarin, those treated at centers with higher rates of therapeutic INR time had lower risks for the composite endpoint of stroke and systemic embolism, major bleeding, and mortality than those treated at centers with lower rates of therapeutic INR time. At centers with lower rates of therapeutic INR time, dabigatran was associated with significant reductions in the composite endpoint of cardiovascular events and total mortality, as compared with warfarin.
Comment: In this study, poor control of INR in patients assigned to warfarin amplified the relative benefits of dabigatran. One would expect that patients who are enrolled in clinical trials would achieve better INR rates than patients who are not. Therefore, these findings suggest that in "real-life" clinical situations, the advantages of dabigatran over warfarin could be even greater than they were in the RE-LY trial.
— Mark S. Link, MD
Published in Journal Watch Cardiology August 30, 2010
# posted by roodbont @ 12:59 PM 
