title: PA tablets: investigational compounds combining aspirin and omeprazole for cardioprotection.
abstract: 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.
authors.affiliation: Sinai Center for Thrombosis Research, 2401 West Belvedere Avenue, Baltimore, MD 21215, USA.
authors.forename: Kevin P
authors.initials: KP
authors.lastname: Bliden
authors.forename: Michael
authors.initials: M
authors.lastname: Brener
authors.forename: Martin G
authors.initials: MG
authors.lastname: Gesheff
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Franzese
authors.forename: Ali
authors.initials: A
authors.lastname: Tabrizchi
authors.forename: Udaya
authors.initials: U
authors.lastname: Tantry
authors.forename: Paul A
authors.initials: PA
authors.lastname: Gurbel
mesh_terms: D000284:Administration, Oral; D001241:Aspirin / Q000008:administration & dosage* / Q000493:pharmacokinetics; D001682:Biological Availability; D002318:Cardiovascular Diseases / Q000378:metabolism / Q000517:prevention & control*; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004347:Drug Interactions; D004359:Drug Therapy, Combination; D006801:Humans; D009853:Omeprazole / Q000008:administration & dosage* / Q000493:pharmacokinetics; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000493:pharmacokinetics; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics; D013607:Tablets
chemical_list: D003692:Delayed-Action Preparations; D010975:Platelet Aggregation Inhibitors; D054328:Proton Pump Inhibitors; D013607:Tablets; D009853:Omeprazole; D001241:Aspirin