Analysis of the interaction between clopidogrel, aspirin, and proton pump inhibitors using the FDA adverse event reporting system database

Yukiya Suzuki, Honami Suzuki, Ryogo Umetsu, Hiroaki Uranishi, Junko Abe, Yuri Nishibata, Yasuaki Sekiya, Nobuteru Miyamura, Hideaki Hara, Teruo Tsuchiya, Yasutomi Kinosada, Mitsuhiro Nakamura

Research output: Contribution to journalArticlepeer-review

25 Citations (Scopus)

Abstract

Clopidogrel is an antiplatelet agent widely used in combination with aspirin to limit the occurrence of cardiovascular (embolic/thrombotic) events. Consensus guidelines recommend proton pump inhibitors (PPIs) as a gastrointestinal (GI) prophylactic measure for all patients receiving dual antiplatelet therapy with clopidogrel and aspirin. The objective of this study was to analyze the effect of the simultaneous use of clopidogrel, aspirin, and PPIs on hemorrhagic and embolic/thrombotic events using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. Reports of hemorrhagic and embolic/thrombotic events between 2004 and 2013 were analyzed with a reporting odds ratio (ROR) algorithm and logistic regression methods. The Medical Dictionary for Regulatory Activities Preferred Terms was used to identify such events. Regarding hemorrhagic events, the adjusted RORs of the concomitant use of aspirin and clopidogrel and those of PPIs prescribed with aspirin and clopidogrel were 4.40 (95% confidence interval [CI], 4.02-4.81) and 3.40 (95% CI, 2.84-4.06), respectively. For embolic/thrombotic events, the adjusted RORs of the concomitant use of aspirin and clopidogrel and those of PPIs prescribed with aspirin and clopidogrel were 2.37 (95% CI, 2.16-2.59) and 2.38 (95% CI, 2.00-2.84), respectively. Among patients included in the FAERS database, the concurrent use of aspirin and clopidogrel with PPIs reduced the adjusted ROR of GI hemorrhagic events. PPIs had little influence on the adjusted ROR of embolic/thrombotic events. These results support the use of PPIs as a preventive measure against GI hemorrhagic events for patients receiving clopidogrel and aspirin.

Original languageEnglish
Pages (from-to)680-686
Number of pages7
JournalBiological and Pharmaceutical Bulletin
Volume38
Issue number5
DOIs
Publication statusPublished - 2015 May 1

Keywords

  • Adverse event reporting system
  • Aspirin
  • Clopidogrel
  • Proton pump inhibitor

ASJC Scopus subject areas

  • Pharmacology
  • Pharmaceutical Science

Fingerprint Dive into the research topics of 'Analysis of the interaction between clopidogrel, aspirin, and proton pump inhibitors using the FDA adverse event reporting system database'. Together they form a unique fingerprint.

Cite this