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Tuesday, 05/21/2013 8:38:02 AM

Tuesday, May 21, 2013 8:38:02 AM

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POZEN: Presence of gastric erosions in patients taking low-dose aspirin for secondary cardiovascular prevention may result in a 2-fold increase in future gastric ulcers (POZN) 4.96 : Co presents data from a post-hoc analysis of Phase 3 data from the investigational compound PA32540. The analysis of patients screened for the Phase 3 studies demonstrated that at any time point, over 4% of subjects on low dose aspirin for cardiovascular and cerebrovascular disease have endoscopic gastric ulcers that go undetected. In addition, the analysis demonstrated that even the presence of small lesions known as endoscopic gastric erosions in aspirin-users was associated with a 2-fold increased risk of future development of endoscopic gastric ulcers.

Key Findings of Post-Hoc Analysis

The baseline rate of gastric ulcers in the screening of the general population of adults using ASA (325 mg) for =3 months for secondary cardiovascular prevention was 4.4%, and was 5.7% for both gastric or duodenal ulcers.
In the post-hoc analysis of subjects with and without gastric erosion at baseline endoscopy, the presence of gastric erosion at baseline was:
Predictive of a higher rate of subsequent gastric erosions for both EC-ASA (325 mg) and PA32540.
Associated with a significant propensity toward future gastric ulcer development in subjects treated with EC-ASA (325 mg), but not in those treated with PA32540.
In patients with baseline gastric erosions, a significantly higher percentage of patients taking EC-ASA (325 mg) developed a gastric ulcer over the six month study period than patients taking PA32540 (13% vs. 4.2%).

Co states these data highlight the need for physicians to identify aspirin patients at risk, and, where appropriate, prescribe gastroprotective agents. Based on American Heart Association and American College of Gastroenterology recommendations, the preferred gastroprotective agents are proton pump inhibitors.