Pozen Inc. (POZN) said it presented data from the combined results of two Phase 3 studies of PA32540, an antiplatelet therapy of enteric-coated or EC and immediate-release omeprazole, in patients with previous cerebrovascular disease. These data were presented at the American Heart Association 2013 International Stroke Conference on Thursday, February 7.
According to the studies, in the post-hoc analysis of subjects with a history of transient ischemic attack or TIA or stroke, long-term (6 months) treatment with PA32540, compared to EC-ASA (325 mg), was associated with a significantly reduced rate of endoscopic gastroduodenal ulcers (2.0% vs. 12.4% respectively; p=0.005), and study discontinuation due to adverse pre-specified upper GI events (0% vs. 8.0% respectively; p=0.006).
The incidence of adjudicated major adverse cardiac events was similar for PA32540 (2.9%) and EC-ASA (325 mg) (4.4%).
"Discontinuation of aspirin therapy is often due to the adverse GI effects of aspirin," said Mark Alberts, UT Southwestern Medical Center, Dallas, Texas.
"In these pivotal studies, PA32540 was associated with a significantly lower rate of treatment discontinuation than aspirin alone. Patient adherence to aspirin therapy saves lives, as aspirin discontinuation increases the likelihood of potential adverse cardiovascular and cerebrovascular events," said Mark Alberts.
AHA guidelines state that the use of an antiplatelet agent, such as aspirin, is recommended to reduce risk of recurrent stroke and other cardiovascular events.
According to the studies, PA32540 is associated with a lower rate of endoscopic gastroduodenal mucosal injury with a similar cerebrovascular event profile as EC-ASA therapy. PA32540, a single tablet containing EC aspirin and IR omeprazole, has a lower rate of discontinuation and, hence, may improve long-term adherence to ASA therapy.
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