Pharmacodynamic evaluation of clopidogrel plus PA32540: the Spaced PA32540 With Clopidogrel Interaction Gauging (SPACING) study

Clin Pharmacol Ther. 2011 Dec;90(6):860-6. doi: 10.1038/clpt.2011.201. Epub 2011 Nov 2.

Abstract

PA32540 combines 325 mg enteric-coated (EC) aspirin (ASA) with 40 mg immediate-release omeprazole; its influence on the antiplatelet effect of clopidogrel (C) is unknown. In this randomized, open-label study, subjects (n = 30) were treated with (i) 300 mg C + 325 mg ECASA followed by 75 mg C + 325 mg ECASA on days 2-7, (ii) 300 mg C + PA32540 followed by 75 mg C + PA32540 on days 2-7, or (iii) PA32540 in the morning + 300 mg C 10 h later on day 1 and PA32540 in the morning + 75 mg C 10 h later on days 2-7. We analyzed the noninferiority of PA32540 relative to ECASA, as defined by the upper bound of the 95% confidence interval ≤10% for the difference in least-square means of platelet inhibition between the treatments. As compared to ECASA+C, synchronous treatment of PA32540+C was not noninferior, whereas the spacing strategy of PA32540+C was noninferior. Spacing the administration of PA32540 and clopidogrel lessens the interaction observed with synchronous administration; PA32540 administration with clopidogrel may be associated with a different antiplatelet profile.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Ulcer Agents / administration & dosage
  • Anti-Ulcer Agents / pharmacology
  • Aspirin / administration & dosage
  • Aspirin / pharmacology*
  • Clopidogrel
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Combinations
  • Drug Interactions
  • Female
  • Humans
  • Least-Squares Analysis
  • Male
  • Omeprazole / administration & dosage
  • Omeprazole / pharmacology*
  • Platelet Aggregation Inhibitors / administration & dosage
  • Platelet Aggregation Inhibitors / pharmacology*
  • Tablets, Enteric-Coated
  • Ticlopidine / administration & dosage
  • Ticlopidine / analogs & derivatives*
  • Ticlopidine / pharmacology

Substances

  • Anti-Ulcer Agents
  • Drug Combinations
  • Platelet Aggregation Inhibitors
  • Tablets, Enteric-Coated
  • Clopidogrel
  • Omeprazole
  • Ticlopidine
  • Aspirin