A new subgroup analysis of the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) trial Treatment indicated that the 150mg twice daily dose of dabigatran (Pradaxa) is equally safe and effective in patients with permanent, persistent, and paroxysmal atrial fibrillation.
Similar to the overall results of the RE-LY study, dabigatran 150mg twice daily was more effective than warfarin for reducing the risk of stroke or systemic embolism and with a comparable risk of bleeding.
Investigators, however, did observe slightly different responses among patients treated with the 110 mg twice daily dose. They found the lower dose, 110mg twice daily, was more effective in patients with paroxysmal atrial fibrillation but less effective in patients with permanent atrial fibrillation.
There was a 40% risk reduction in stroke among paroxymal-AF patients treated with dabigatran 110mg twice daily, but this risk was not reduced in permanent AF patients treated with the 110mg dose.
Investigators are analyzing the data to see whether the lack of efficacy among the permanent AF patients treated with the lower dose of dabigatran was due to chance.
This sub-analysis indicated that dabigatran 150mg is safe and effective in all types of AF patients.
Readers are reminded that the 110 mg dose is not available in theUS. Instead, the Food and Drug Administration approved a 75-mg twice daily dose for patients with kidney disease (creatinine clearance between 15 and 30 mL/min).
Source: Presented at theAmericanCollegeof Cardiology (ACC) 2011.
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