POZEN Inc. (NASDAQ: POZN)
a pharmaceutical company committed to transforming medicine that transforms lives, presented data today from the combined results of two Phase 3 studies of PA32540, an antiplatelet therapy of enteric-coated (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 at 4:15 p.m. (HST) in Honolulu, Hawaii at the Hawaii Convention Center as poster board number MP103.
According to the studies, in the post-hoc analysis of subjects with a history of transient ischemic attack (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 J. Alberts, MD, 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.”
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.
Key Findings of the Study
About the Study
- 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.
The two Phase 3, double-blind, randomized, multicenter studies enrolled 1,049 subjects who were prescribed daily aspirin (325 mg) for greater than or equal to three months for secondary prevention of cardiovascular events. The primary endpoint was the cumulative observed incidence of gastric ulcers over six months. Secondary endpoints included cumulative incidence of gastric and duodenal ulcers, discontinuation due to pre-specified UGI adverse events and heartburn resolution. Subjects were randomly assigned to once-daily treatment with PA32540 or 325 mg of enteric-coated aspirin. Endoscopic assessments were performed at screening and at one, three and six months. MACE were reviewed and adjudicated by an independent, blinded endpoint committee composed of Cardiologists.