Just came up on the Google news alert. Was not familiar with this drug.
Ximelagatran Potential Alternative to Warfarin in Prevention of Stroke in Patients with Atrial Fibrillation
A DGReview of :"Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomised controlled trial"
Lancet
12/16/2003
By Deanna M Green, PhD
Ximelagatran prevents stroke as effectively as does warfarin and has a lower occurrence of bleeding events, according to an international phase III study.
Warfarin is highly effective for preventing stroke in patients with non-valvular atrial fibrillation although it is associated with a high risk of haemorrhage and must be carefully monitored due to potential drug interactions.
S. Bertil Olsson, MD, at the University Hospital, Lund, Sweden, and investigators participating in the SPORTIF (Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation) III Study evaluated whether the new oral direct thrombin inhibitor ximelagatran is as effective as warfarin in the prevention of stroke and systemic embolism in high-risk patients with atrial fibrillation.
The study included 3,410 patients who were randomised to open-label ximelagatran (36 mg twice daily) or warfarin (dose-adjusted to maintain the international normalised ratio [INR] between 2.0 and 3.0).
Notably, more patients in the ximelagatran group took aspirin (<100 mg/day) for at least half the study period (13% vs. 10% with warfarin, P = .010). Incidence of any stroke or systemic embolism event was assessed throughout a mean follow up of 17.4 months.
A primary event occurred in 56 patients taking warfarin and in 40 patients taking ximelagatran, indicating a yearly rate of 2.3% and 1.6%, respectively. This represented an absolute risk reduction of 0.7% per year (P = .10) or a relative risk reduction of 29%.
Similar rates of all-cause mortality, vascular death, fatal stroke or non-fatal disabling stroke were seen between groups.
However, significantly more bleeding events occurred in patients given warfarin (29.8% vs. 25.8% with ximelagatran, P = .0065). Moreover, patients concurrently taking aspirin had a significantly greater incidence of any bleeding event.
Ximelagatran treatment was associated with elevated serum alanine aminotransferase levels, above 3 times the upper limit of normal (6% vs. 1% with warfarin, P < .0001). Notably, the increased levels returned to baseline without clinical sequelae either spontaneously or with discontinuation of treatment.
The authors conclude that "ximelagatran, administered in a fixed dose without coagulation monitoring, protects high risk patients with atrial fibrillation against thromboembolism at least as effectively as well-controlled warfarin, and is associated with less bleeding."
Don R.
