Just last week, I wrote about Xarelto (rivaroxaban), a factor Xa inhibitor, which had just been approved to prevent strokes in patients with atrial fibrillation. In a
study simultaneously announced at the annual AHA meeting and published in NEJM yesterday, the authors noted that
low dose rivaroxaban decreased cardiovascular mortality when started in the setting of an acute coronary syndrome and used for an average of 13mo, up to 31mo. This added benefit was found in addition to therapeutic standard of care anti-platelet agents, eg aspirin plus a thienopyridine, either clopidogrel or ticlopidine (pasugrel apparently was not available or in use at the time of this study).
It should be noted that both 2.5mg twice daily and 5mg twice daily were studied against placebo in a randomized, triple-blind fashion, of course. As expected, more bleeding events were associated with the larger dose of rivaroxaban than the lower dose compared to placebo. The
editorialists commented that, in fact, this was the Achilles tendon of previous attempts at prophylactic anticoagulation, eg warfarin, dalteparin (low molecular weight heparin), and ximelagatran (direct thrombin inhibitor), with late bleeding events and other side effects exceeding early cardiac benefit.
One final note: in a
separate commentary, others not involved in the study noted that only a small fraction of the participants were from North America, with most being enrolled in Eastern Europe, Asia & Europe. This was pointed out since not all studies may be generalizable to your patient population. So keep this in mind as you consider additional therapy to address your patient's residual risk, that portion which remains after our current best efforts.
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