Key result
PA tablets, combining 40 mg omeprazole and 81 or 325 mg aspirin, were developed to provide cardioprotection with improved gastrointestinal safety compared to enteric-coated aspirin alone.
Why the study?
Do PA tablets (aspirin and omeprazole) improve gastrointestinal safety relative to enteric-coated aspirin alone in patients requiring secondary cardiovascular prevention?
Do PA tablets (aspirin and omeprazole) improve gastrointestinal safety relative to enteric-coated aspirin alone in patients requiring secondary cardiovascular prevention?
PA tablets combining aspirin and omeprazole are being developed to provide cardioprotection with improved gastrointestinal safety compared to aspirin alone.
PA tablets may enhance GI safety during aspirin therapy; leaves open whether they outperform enteric-coated aspirin in secondary prevention.
For most patients with prior cardiovascular events, preventing future secondary cardiovascular events requires life-long persistence with antiplatelet therapy. PA tablets (P: proton pump inhibitors; A: aspirin) are investigational compounds that were developed to provide the cardioprotective benefits of aspirin with the upper gastrointestinal protection of a proton pump inhibitor (e.g., omeprazole). The tablets are film-coated, coordinated-release tablets for oral administration that contain 40 mg immediate-release omeprazole and either 81 or 325 mg delayed-release aspirin. The goals of the clinical development program were to demonstrate the following: improved gastrointestinal safety of PA relative to enteric-coated aspirin alone; bioequivalence and comparative bioavailability between the PA compounds and currently marketed enteric-coated aspirin; and long-term safety. Two clinical pharmacology studies were also conducted to study the potential for interaction between PA32540 and clopidogrel.
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Bliden et al. (2013) conducted a review in Prior cardiovascular events. PA tablets (aspirin and omeprazole) vs. Enteric-coated aspirin alone was evaluated. PA tablets, combining 40 mg omeprazole and 81 or 325 mg aspirin, were developed to provide cardioprotection with improved gastrointestinal safety compared to enteric-coated aspirin alone.
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