Cardiology Medical News about vitamin K antagonists, stroke prevention, atrial fibrillation, direct thrombin inhibitor, AZD0837

Become a Member Today!
Register

Most Viewed Abstracts

1. Report Shows Shift in Starting Salaries for Physicians

2. Pre-participation screening of young competitive athletes for prevention of sudden cardiac death

3. The Job Market for 2008-2009: Compensation

4. Renal Artery Stenosis

5. AHA Guidelines on Cardiac CT for Assessing Coronary Artery Disease

Your Article Summary

See Latest Articles

(Click the title below to leave the MDLinx Network and go to the Journal's Website)

Oral direct thrombin inhibitor AZD0837 for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: A randomized dose-guiding, safety, and tolerability study of four doses of AZD0837 vs. vitamin K antagonists
European Heart Journal, 08/24/09

Lip GYH et al. – AZD0837 was generally well tolerated at all doses tested. AZD0837 treatment at an exposure corresponding to the 300 mg once daily dose provides similar suppression of thrombogenesis at a potentially lower bleeding risk compared with dose-adjusted vitamin K antagonists (VKAs).

Methods

Report from phase II randomized, dose-guiding study to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of extended-release AZD0837 in pt with atrial fibrillation (AF)
Randomization of 955 AF pts with ≥1 additional risk factor for stroke to receive AZD0837 (150, 300, or 450 mg once daily or 200 mg twice daily) or VKA (international normalized ratio 2–3, target 2.5) for 3–9 mo
Treatment naïve: ~30% of pts naïve to VKA treatment

Results

Total bleeding events similar or lower in all AZD0837 groups (5.3%–14.7%, mean exposure 138–145 days) vs VKA (14.5%, mean exposure 161 days), with fewer clinically relevant bleeding events on AZD0837 150 and 300 mg once daily
Adverse events similar between treatment groups
Most common with AZD0837: gastrointestinal disorders (diarrhea, flatulence, nausea)
D-dimer, as biomarker of thrombogenesis, decreased in all groups in VKA-naïve pts with treatment
VKA pre-treated pts: D-dimer levels started low and remained low in all groups
In AZD0837 groups, mean S-creatinine increased by ~10% from baseline and returned to baseline after treatment cessation
Frequency of serum alanine aminotransferase ≥3x upper limit of normal similar for AZD0837 and VKA

<< Previous
Exercise capacity, quality of life, and daily activity in the...

Next >>
A meta-analysis of 3,773 patients treated with percutaneous...