Abstract 12057: Treatment Continuation and Cardiovascular Safety of Antiplatelet Therapy with PA32540, a Tablet With Enteric-coated Aspirin and Immediate-release Omeprazole: Results of Two 6-month, Phase 3 Studies
Introduction: Proton pump inhibitors (PPIs) can significantly reduce aspirin-associated gastrointestinal (GI) symptoms that impact adherence to long-term antiplatelet therapy. PA32540 is a coordinated-delivery tablet of immediate-release (IR) omeprazole (40 mg) and enteric-coated (EC) aspirin (325 mg). We hypothesized that PA32540 would have better upper GI tolerability and treatment continuation compared with EC aspirin 325 mg while maintaining the cardiovascular benefits of aspirin.
Methods: Two phase 3 double-blind multicenter studies enrolled 1,049 subjects prescribed daily aspirin at 325 mg for ≥3 months for secondary prevention of cardiovascular events. Subjects were randomly assigned to once-daily treatment with PA32540 or 325 mg of EC aspirin. Endoscopic assessments were performed at screening and at 1, 3, and 6 months. Major adverse cardiac events (MACE) were adjudicated by an independent blinded endpoint committee.
Results: Baseline characteristics and rates of discontinuation are shown in Table 1. Endoscopic gastric ulcers, which per protocol required termination from the study, are shown. Independent of gastric ulcers, discontinuations due to upper GI events and discontinuations due to adverse events were significantly lower following administration of PA32540 vs EC aspirin alone over 6 months. As presented in Table 2, no significant difference in MACE was identified.
Conclusion: PA32540 was associated with a significantly higher rate of treatment continuation compared with aspirin alone and no increase in serious cardiovascular events. These results further support the achieved primary endpoint of the reduced rate of gastric ulcers in the 2 trials. The findings have important implications for the use of PA32540 in the long-term management of patients requiring aspirin for secondary prevention.
- Antiplatelet drugs
- Symptom management
- Patient safety
- Cardioprotective drugs
- Cardiovascular disease prevention
- © 2012 by American Heart Association, Inc.