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POZEN Inc Announces Results Of PA32540 Phase 3 Post-Hoc Analysis Presented At DDW 2013 Also Revealed That Over 4% of These Patients May Have Gastric Ulcers Without Knowing It

Tuesday, 21 May 2013 07:30am EDT 

POZEN Inc announced that it presented the Abstract, Prevalence of Gastric Ulcers in Aspirin Users/Does the Presence of Erosions Foreshadow Ulcer Development, 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 (ASA) for cardiovascular and cerebrovascular disease have endoscopic gastric ulcers (GUs) 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. These data highlight the need for physicians to identify aspirin patients at risk, and, where appropriate, prescribe gastroprotective agents. Based on American Heart Association (AHA) and American College of Gastroenterology (ACG) recommendations, the preferred gastroprotective agents are proton pump inhibitors (PPIs). In patients with gastric erosions at baseline, PA32540, a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), layered around a pH-sensitive coating of a 325 mg ASA core, resulted in significantly fewer gastric ulcers at six months vs. EC-ASA (325 mg) (4.2% vs. 13.0%; p=0.001) These data were presented for the first time at Digestive Disease Week (DDW) 2013 in Orlando, Florida at the Orange County Convention Center on May 20, 2013. 

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26 Nov 2014