AZD0837 "comparable" profile to VKAs in Ph II study

Data presented at the annual meeting of the American College of Cardiology in Florida, show that Anglo-Swedish drug major AstraZeneca's  once-daily oral direct thrombin blocker AZD0837 showed similar or lower  total bleeding rates at a comparable level of anticoagulation - as  measured by biomarkers - compared to vitamin K antagonists, the current  treatment standard, in atrial fibrillation patients.

In the Phase II dose-guiding study, which involved 955 AF patients with  one or more additional risk factor for stroke, AZD0837 was associated  with a similar suppression of blood clot formation, as well-controlled  VKA in the 300mg od, 450mg od and 200mg bid treatment groups. The study  demonstrated that AZD0837 is generally well tolerated. Total bleeding  events were similar or less in all AZD0837 groups (5.3% - 14.1%, mean  exposure: 138 - 145 days) compared with VKA (14.5% mean exposure: 160  days). Clinically-relevant bleeding events in the whole cohort and the  VKA-naive sub-group were numerically less common in certain of the  AZD0837 groups.

A similar frequency of serum alanine aminotransferase greater than three  times the upper limit of normal was seen with AZD0837 compared to VKA  (2.3% vs 1.6% respectively). High ALT levels saw the demise of AZD0837's  predecessor Exanta (melagatran/ximelagatran), which was withdrawn from  the market in February 2006 on concerns that it may cause liver  injury.