Presentations at the recently concluded American Heart Association sessions further support approval and use of Exanta. Further data from the SPORTIF trials support the claim that Exanta’s benefits are similar to those of warfarin in the management of the thrombotic complications of atrial fibrillation. Additionally, a separate study shows that Exanta plus aspirin is superior to aspirin alone for the prevention of major cardiovascular events during 6 months of treatment in patients having had a recent myocardial infarction (MI, heart attack). A third study shows that Exanta plus aspirin outperformed a gpIIb/IIIa inhibitor plus aspirin in minimizing arterial thrombosis. These data support approval then significant use of Exanta and other direct thrombin inhibitors in the management of a wide array of both venous and arterial thromboembolic conditions.

Wallentin, et al published an 1883-patient, exploratory, randomized, double-blind, placebo-controlled, dose-guiding, phase II investigation assessing Exanta plus aspirin’s utility for minimizing severe recurrent ischemia after a recent, acute ST-elevation or non-ST-elevation MI. Randomization in a 2:1:1:1:1 ratio within 14 days of the index event occurred. Study subjects received aspirin 160 mg once daily with either placebo or Exanta 24 mg, 36 mg, 48 mg, or 60 mg twice daily for 6 months. The primary composite endpoint was death, nonfatal MI, or recurrent ischemia.

The combined Exanta groups’ significant advantage was a lowered risk for the composite primary endpoint – 16.3% (102/638) to 12.7% (154/1245), p=0.036. Dose-response was not observed, solidifying the notion of the utility of fixed dosing. Major bleeds were uncommon, but, as expected, were more incident with Exanta (1.8% [23/1245] and 0.9% [6/638]). Exanta’s liver function test profile remained predictable and manageable. 12 month follow-up appraisal will follow if significantly different.

In a separate study of 62 healthy men, Exanta plus aspirin showed multiple significant advantages, over clopidogrel plus aspirin, in terms of antithrombotic effect.

In the massive, highly-powered, combined SPORTIF III and SPORTIF V programs, the event rate (stroke plus systemic embolic events) for patients with atrial fibrillation was 1.6%/year whether one received Exanta- or warfarin-based management. As important was the finding that despite no coagulation monitoring or dose titration for the Exanta group, SPORTIF V major bleeding rates were 2.4% for the Exanta group and 3.1% for the warfarin group, a difference that was not statistically significant. Over both trials, an assessment of the combined rates of deaths, primary events, and major bleeding yielded a 5.2% event rate with Exanta and a 6.2% event rate with warfarin (p=0.038, significant Exanta advantage). Adverse bleeding and liver enzyme elevation profiles remained predictable and manageable.