How do those [Eliquis] numbers compare vs Pradaxa?
All told, the Eliquis data from the ARISTOTLE study are even better than the Pradaxa data from the RE-LY study, IMO.
Although Pradaxa did better than Eliquis (35% vs 21%) on the primary endpoint of reducing the risk of stroke (compared to warfarin), Eliquis accomplished two things that Pradaxa did not: a statsig reduction in the risk of major bleeding (compared to warfarin) and a statsig reduction in the risk of all-cause mortality (compared to warfarin). These secondary-endpoint results—especially the clinically meaningful reduction in major bleeding—will give BMY/PFE a huge assist in marketing Eliquis against Pradaxa in the AF/stroke-prevention indication.
Moreover, the Pradaxa RE-LY study excluded the highest-risk patients: those who suffered a stroke during the six months prior to enrollment. Had these secondary-prevention patients been included in RE-LY, as they were in ARISTOTLE, Pradaxa might have shown efficacy on the primary endpoint that was no better than what Eliquis showed in ARISTOTLE.
Finally, Pradaxa requires dose reduction for patients with renal impairment, which includes a large swath of the patient pool in question. At the reduced dose (75mg BID rather than 150mg BID), Pradaxa is statsig less efficacious than at the regular dose.
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