Pharmacodynamic evaluation of clopidogrel plus PA32540: The spaced PA32540 with clopidogrel interaction gauging (SPACING) study

P. A. Gurbel, K. P. Bliden, J. Fort, Y. Zhang, J. R. Plachetka, M. Antonino, M. Gesheff, U. S. Tantry

Research output: Contribution to journalArticlepeer-review

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 ECASAC, 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.

Original languageEnglish (US)
Pages (from-to)860-866
Number of pages7
JournalClinical pharmacology and therapeutics
Volume90
Issue number6
DOIs
StatePublished - Dec 1 2011

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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