POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, presented a post-hoc analysis of diabetic subpopulation results from two Phase 3 PA32540 (325 mg enteric-coated (EC) aspirin / 40 mg immediate-release omeprazole) studies at the American Diabetes Association’s 73 rd Scientific Session. Nearly 40% of patients in the Phase 3 studies had diabetes and were on aspirin (325 mg) for secondary prevention of cardiovascular (CV) events. In this subpopulation of four hundred patients, PA32540 was associated with a significantly lower rate of endoscopic gastroduodenal ulcers, as compared to taking aspirin alone (2.3% vs. 11.2%, p<0.001). A lower rate of treatment discontinuation was also shown for this PA32540 subpopulation (1.4% vs. 5.9%, p=0.018). These data were presented for the first time on Monday, June 24 th at noon (CT) at the McCormick Place Convention Center in Chicago, Illinois, as poster board number 425-P.
“Patients with diabetes and prior cardiovascular events may require daily life-long treatment with aspirin,” said John G. Fort, M.D., Chief Medical Officer of POZEN and co-author of the poster. “We are pleased that these findings support the use of an integrated tablet of omeprazole and aspirin as antiplatelet therapy for secondary cardiovascular prevention in diabetic patients at risk for gastric ulcers.”
Diabetes is associated with an approximate 2-fold increased risk for cardiovascular disease, including non-fatal myocardial infarction and ischemic stroke. The American Diabetes Association Standards of Medical Care specifically recommend low-dose aspirin therapy for secondary cardiovascular disease prevention in patients with diabetes and a history of cardiovascular disease. Studies have shown that patients (including those with a history of diabetes) who experience upper gastrointestinal complications from aspirin therapy may stop treatment. Discontinuations or interruptions in aspirin therapy in cardiovascular disease patients have been reported to increase the risk of future cardiovascular events.