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Endoscopic Ulcer Rates in Healthy Subjects Associated with Use of Aspirin (81 mg q.d.) Alone or Coadministered with Celecoxib or Naproxen: A randomized, 1-Week Trial

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Abstract

Aim: To determine the rate of endoscopic gastric/duodenal ulcers (GDUs) associated with use of aspirin (81 mg q.d.) alone or coadministered with celecoxib or naproxen. Methods: In this multicenter, double-blind study, healthy subjects were randomized to receive daily aspirin (81 mg q.d.) plus celecoxib 200 mg q.d., naproxen 500 mg b.i.d., or placebo. Upper endoscopy was performed at baseline and day 7. The primary end point was incidence of GDUs ≥3 mm diameter. Results: Incidence of GDUs was significantly lower in subjects receiving celecoxib plus aspirin (7%) compared with naproxen plus aspirin (25.3%; relative risk [RR], 0.28 [95% confidence interval (CI), 0.17–0.45]; P < 0.001), but significantly higher than placebo plus aspirin (1.6%; RR, 4.78 [95% CI, 1.12–20.32]; P = 0.016). Conclusion: In a healthy population taking aspirin (81 mg q.d.), coadministration of celecoxib resulted in fewer GDUs than naproxen, but significantly more mucosal damage than aspirin alone.

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Acknowledgements

Dr Goldstein participated in the trial design, data interpretation and writing of this manuscript. Dr Aisenberg participated in data interpretation and writing of the manuscript. Dr Zakko contributed to data acquisition and interpretation, and manuscript review and revision. Dr Berger was involved with study design, data analysis, and interpretation. Dr Dodge contributed to statistical methodology, analysis and interpretation of results. Author’s declaration of personal interests: Dr Goldstein is a consultant to and has received travel expenses, educational grants, research grants and contracts, and speaker honoraria from Pfizer Inc., AstraZeneca, TAP, Takeda, POZEN, and Sucampo. Dr Aisenberg is a consultant to and has received speaker honoraria from Pfizer Inc. Dr Berger and Dr Dodge are full-time employees of Pfizer Inc. Declaration of funding interests: Funding for this research project was provided by Pfizer Inc., NY, USA. Editorial support was provided by S. Robinson, PhD, at PAREXEL and was funded by Pfizer Inc.

Author information

Authors and Affiliations

  1. College of Medicine, University of Illinois at Chicago, Room 1020 CSB—10th Floor (M/C 787), 840 S Wood Street, Chicago, IL, 60612, USA

    Jay L. Goldstein

  2. The Mount Sinai Medical Center, New York, NY, USA

    James Aisenberg

  3. The Connecticut Gastroenterology Institute at Bristol Hospital, Bristol, CT, USA

    Salam F. Zakko

  4. Pfizer Inc, New York, NY, USA

    Manuela F. Berger & William E. Dodge

Authors
  1. Jay L. Goldstein
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  2. James Aisenberg
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  3. Salam F. Zakko
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  4. Manuela F. Berger
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  5. William E. Dodge
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Corresponding author

Correspondence to Jay L. Goldstein.

Appendix

Appendix

The following were investigators for the current study:

James Aisenberg, MD; Francisco J. Baigorri, MD; Charles F. Barish, MD; Michael T. Bennett, MD; Donald M. Brandon, MD; Antonio Caos, MD; Kenneth G. Davis, MD; Garth C. Denyer, MD; Madeleine Ann DuPree, MD; Gary P. Erdy, MD; David Eskreis, MD; Harry I. Geisberg, MD; Larry I. Gilderman, DO; Jay L. Goldstein, MD; Mark Graves, MD, Charles E. Hall, MD; Robert Hardi, MD; John F. Johanson, MD; Shelly P. Kafka, MD; Seymour Katz, MD; Richard A. Krause, MD; Frank L. Lanza, MD; Arnold I. Levin, MD; Mark L. Lloyd, MD; David M. Maccini, MD; Pramod Malik, MD; Frederick T. Murphy, DO; Frederick H. Opper, MD; Daniel J. Pambianco, MD; Kevin D. Plancher, MD; Bruce G. Rankin, DO; Gregory G. Rick, Jr., MD; Dennis S. Riff, MD; Alan V. Safdi, MD; Douglas R. Schumacher, MD; Howard I. Schwartz, MD; Michael E. Schwartz, DO; Gladstone Sellers, MD; Bavikatte N. Shivakumar, MD; David R. Silvers, MD; Joseph Soufer, MD; Michael Tachman, MD; Barry D. Winston, MD, Salam F. Zakko, MD.

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Goldstein, J.L., Aisenberg, J., Zakko, S.F. et al. Endoscopic Ulcer Rates in Healthy Subjects Associated with Use of Aspirin (81 mg q.d.) Alone or Coadministered with Celecoxib or Naproxen: A randomized, 1-Week Trial. Dig Dis Sci 53, 647–656 (2008). https://doi.org/10.1007/s10620-007-9903-4

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