Abstract 124: Bridging Clinical Trial and Community-Based Cardiovascular Outcomes With Antiplatelet Therapy: An Analysis of Cardiovascular Outcomes in a Phase 3 Long-Term Safety Study of PA32540 Compared to a Matched Community-Based Sample

Background: Improvements in antiplatelet strategies could have a significant impact on cardiovascular (CV) events. PA32540 is a novel single-dose tablet of 325 mg enteric-coated aspirin and 40 mg immediate-release omeprazole developed to significantly reduce upper gastrointestinal (UGI) toxicity and discontinuation due to aspirin-associated UGI symptoms. In order to bridge the potential clinical benefits of PA32540 to a broader community setting, we compared CV and gastrointestinal (GI) outcomes from a long-term, open-label PA32540 Phase 3 clinical trial to CV and GI outcomes in a community setting (CS). Objective: To assess 2 clinically and demographically matched patient populations receiving treatment for secondary CV prevention: one group treated with PA32540, and the other group treated with standard antiplatelet therapy. Methods: All patients were receiving secondary CV preventive therapy and were at risk for GI events. Patients (n=379) from a 12-month Phase 3 open-label clinical trial of PA32540 were matched to CS patients (n=379) prescribed antiplatelet therapy following an index CV event from a retrospective (2001-2010) claims analysis database. Patients were matched on clinical and demographic variables that included gender, age (±2 years), history of proton pump inhibitor use, and nonsteroidal anti-inflammatory drug use. The relationship between CV outcomes and multiple demographic variables (eg, age, race, comorbidities) were examined. Results: Within 12 months of initiating preventive secondary CV therapy, 18% (68/379) of CS patients and 13% (49/379) of PA32540 patients experienced a secondary CV event. This corresponds to a 28% reduction of reported CV events compared with similar CS patients (Figure). Similarly, the proportion of patients experiencing a serious GI event was 3.7% (14/379) in the CS group and 0.8% (3/379) in the PA32540 group; a 78.6% reduction. Conclusions: Fewer CV and GI events occurred among the open-label Phase 3 clinical trial patients treated with PA32540 than among the matched population of CS patients receiving antiplatelet therapy. These data suggest that a further reduction in secondary CV outcomes may be achieved by reducing aspirin-associated UGI symptoms that may lead to discontinuation of antiplatelet therapy. ![][1] [1]: /embed/graphic-1.gif