Aggrenox®/Asasantin®Retard contains a fixed dose combination of
modified/extended - release dipyridamole 200 mg and aspirin 25 mg. Aggrenox® / Asasantin®Retard
is approved twice
daily for the secondary prevention of thromboembolic stroke in patients who have had a previous stroke or transient
ischaemic attack (TIA). In a placebo-controlled, pivotally designed and conducted 2 x 2 factorial clinical trial
Aggrenox® modified extended release dipyridamole(Asasantin®Retard), aspirin and placebo were given singly. All three active treatments were superior to placebo. Thus, in the Second European Stroke
Prevention Study (ESPS 2) treatment with aspirin 25 mg twice daily showed a statistically significant 18% reduction
in relative stroke risk and modified-release dipyridamole 200 mg twice daily showed a significant 16% reduction
in risk. Treatment with the combination in Aggrenox® showed a substantial and highly statistically significant
reduction in relative stroke risk of 36.8 % compared with placebo and twice as effective compared with aspirin.
The combination treatment was not associated with bleeding complications beyond those already known for aspirin alone.
In addition Serebruany et al. have reported in a meta-analysis in 338.191 patients of bleeding following anti platelet
treatment that Aggrenox® was associated with the lowest risk of treatment-related bleeding.
