Safety of fixed-dose aspirin-extended-release dipyridamole in patients with ischemic heart disease.

The safety of fixed-dose combination aspirin-extended-release (ER) dipyridamole for stroke prevention in patients with ischemic heart disease is reviewed. Randomized controlled trials have established the superiority of aspirinER dipyridamole over aspirin alone for secondary stroke prevention. One limitation of this product is the potential risk of worsening angina in patients with coronary artery disease. The English-language medical literature was searched for articles describing the cardiac safety of oral dipyridamole alone or in combination with aspirin. Meta-analyses, randomized controlled trials, observational studies, and case reports presenting information on the cardiac safety of oral dipyridamole were also reviewed. Four meta-analyses described vascular events with dipyridamole using various dosing strategies. Three trials included the endpoint of myocardial infarction in patients receiving ER dipyridamole. The meta-analyses and randomized controlled trials specifically evaluating aspirin-ER dipyridamole did not provide evidence of increased risk of vascular events. One post hoc analysis of a randomized controlled trial specifically assessed the cardiac safety of fixed-dose aspirin-ER dipyridamole and found that dipyridamole was not associated with a higher number of cardiac events compared with aspirin alone. One randomized controlled trial evaluated the efficacy of ER dipyridamole in patients with preexisting ischemic heart disease and found no evidence of increased risk of cardiac events in this population. No published reports were located describing angina with the combination product. A literature review revealed that fixed-dose aspirin-ER dipyridamole was not associated with an increased risk of cardiovascular events in patients with ischemic heart disease. However, individual patient factors merit consideration when choosing an antiplatelet agent for stroke prevention.