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FDA Recommends Dabigatran Approval
Agree with no ASA, still skeptical on RE LY vs new management options

Henry I. Bussey, Pharm.D.
September, 2010

Earlier this week, the FDA panel unanimously recommended that the FDA approve dabigatran. When theheart.org posted this information, it drew a number of comments, which you can review at theheart.org/article/1123797.do#comments.

I agree that data do not support the need to add aspirin in non-stented patients as long as INR is fairly well controlled. In ASPECT 2 and WARIS II, warfarin alone was at least as safe and effective as warfarin + ASA, and superior to ASA alone. Even in "valve" studies, the studies that showed benefit with ASA usually had poor INR control (below target about 50% of the time).

Data presented by Wallentin (theheart.org/article/1046957.do) on the composite of major events suggest the 50% of warfarin-treated patients (individual time in range > 67% of the time) did better (5.3%/yr maj events) than either dagibatran arm (7%/yr maj events). But those with "poor" INR control (< 53% time in range) did much worse (11.9%/yr maj events)than those on dabigatran. Also the wide use of ASA in RE LY may have increased bleeding with warfarin while possibly blunting the questionable increase in MI with dabigatran (see clotcare.org/dabigatran_vs_warfarin.aspx). Combining patient self-testing with online management (with any of 2 or 3 available sysems) can greatly improve efficiency of management and achieve time in range of about 80% overall. If we change our management model, then the most cost-effective and justifiable approach may be to use warfarin + self-testing for those whose INRs are easily controlled and embrace dabigatran as a welcomed alternative for those who have difficulty maintaining optimal INR control. But we must not forget the need to educate patients and monitor for both bleeding and adherence to the medication regimen regardless of medication selected since major bleeding remains a significant risk with either agent.

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