Clinical Studies

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Important Information About AGGRENOX

AGGRENOX is indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.

The most common adverse event with AGGRENOX was headache (39.2% vs 32.9% with placebo), which was more frequent at the onset of therapy but diminished over time. In ESPS 2, GI bleeding with AGGRENOX was comparable to aspirin (4.1% vs 3.2%) and the incidence of intracranial hemorrhage was nine (9) patients (0.6%) in the AGGRENOX group, six (6) patients (0.5%) in the extended-release dipyridamole group, six (6) patients (0.4%) in the aspirin group and seven (7) patients (0.4%) in the placebo group.

AGGRENOX contains aspirin. Patients who consume three or more alcoholic drinks every day should be counseled about the bleeding risks involved with chronic, heavy alcohol use while taking aspirin. Even low doses of aspirin can increase bleeding time, which can adversely affect patients with bleeding disorders. Patients with a history of active peptic ulcer disease should avoid using aspirin, which can cause gastric mucosal irritation and bleeding. AGGRENOX should be avoided in the third trimester of pregnancy.

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