PA tablets: investigational compounds combining aspirin and omeprazole for cardioprotection

Future Cardiol. 2013 Nov;9(6):785-97. doi: 10.2217/fca.13.67.

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.

Publication types

  • Review

MeSH terms

  • Administration, Oral
  • Aspirin / administration & dosage*
  • Aspirin / pharmacokinetics
  • Biological Availability
  • Cardiovascular Diseases / metabolism
  • Cardiovascular Diseases / prevention & control*
  • Delayed-Action Preparations
  • Dose-Response Relationship, Drug
  • Drug Interactions
  • Drug Therapy, Combination
  • Humans
  • Omeprazole / administration & dosage*
  • Omeprazole / pharmacokinetics
  • Platelet Aggregation Inhibitors / administration & dosage*
  • Platelet Aggregation Inhibitors / pharmacokinetics
  • Proton Pump Inhibitors / administration & dosage
  • Proton Pump Inhibitors / pharmacokinetics
  • Tablets

Substances

  • Delayed-Action Preparations
  • Platelet Aggregation Inhibitors
  • Proton Pump Inhibitors
  • Tablets
  • Omeprazole
  • Aspirin