What Are the Net Benefits of Single vs. Double Doses of Dabigatran in AFib Patients?

Both single and double doses of dabigatran are superior to warfarin in AFib patients and have similar benefits when considering a weighted efficacy and safety estimate, according to a study published June 11 in the Journal of the American College of Cardiology.

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Using the 18,113 AFib patients in the previously reported RE-LY Trial, the study compared the benefit of dabigatran 110 mg bid and 150 mg bid to warfarin. Results showed that "compared with warfarin, there was a significant decrease in ischemic stroke equivalents (an integration of ischemic and bleeding events including ischemic stroke, non-CNS systemic embolism, hemorrhagic stroke, subdural bleeding, major extracranial bleeding [major bleeding excluding extracranial bleeding] and MI) with both dabigatran doses: -0.92 per 100 patient years (95 percent CI: -1.74 to -0.21, p=0.02) with dabigatran 110mg bid and -1.08 (95 percent CI: -1.86 to -0.34, p=0.01) with dabigatran 150mg bid." In addition, "there was no significant difference in ischemic stroke equivalents between the two doses: -0.16 (95 percent CI: -0.80 to 0.43) comparing dabigatran 150mg bid with 110 bid."

The authors note that, "when comparing the two doses of dabigatran, their net clinical benefit is similar irrespective of whether death is included in the calculation of net benefit. The results are also similar when net benefit is examined using unweighted composite outcomes that include various combinations of major efficacy and safety events."

"These data support a role for both the 110 mg and the 150 mg dose of dabigatran in clinical practice and the approach of tailoring the dose based on individual patient characteristics," they add.

Keywords: Stroke, beta-Alanine, Benzimidazoles, Warfarin, Atrial Fibrillation

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