Digestive Diseases and Sciences

, Volume 53, Issue 8, pp 2059–2065

Primary Prevention of Adverse Gastroduodenal Effects from Short-Term Use of Non-Steroidal Anti-Inflammatory Drugs by Omeprazole 20 mg in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Study

  • Jay C. Desai
  • Shefali M. Sanyal
  • Tyralee Goo
  • Ariel A. Benson
  • Carol A. Bodian
  • Kenneth M. Miller
  • Lawrence B. Cohen
  • James Aisenberg
Original Paper

DOI: 10.1007/s10620-007-0127-4

Cite this article as:
Desai, J.C., Sanyal, S.M., Goo, T. et al. Dig Dis Sci (2008) 53: 2059. doi:10.1007/s10620-007-0127-4

Abstract

The effectiveness of low-dose omeprazole as primary prevention of gastrointestinal adverse events due to episodic use of non-selective NSAIDs was evaluated. Healthy adults aged 50–75 who did not take chronic NSAIDs were randomized to a 6.5-day treatment of naproxen 500 mg twice daily plus omeprazole 20 mg daily or naproxen 500 mg twice daily plus placebo. Seventy subjects were enrolled (mean age 58.6 years, proportion >60 = 41.4%). Subjects receiving naproxen plus omeprazole developed fewer gastroduodenal ulcers compared to subjects receiving naproxen plus placebo (11.8% vs. 46.9%, P = 0.002). Likewise, naproxen plus omeprazole was associated with a decreased risk of ulceration and/or >5 erosions (38.2% vs. 81.3%, P ≤ 0.001), and a smaller change in dyspepsia score. Considering their relatively low cost, ready availability, and favorable safety profile, low-dose PPI co-prescription in healthy adults requiring short-term therapy with non-selective NSAIDs may be reasonable.

Keywords

Non-steroidal anti-inflammatory agentsPrimary preventionProton pump inhibitorsPeptic ulcerDyspepsiaAnti-ulcer agents

Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Jay C. Desai
    • 1
  • Shefali M. Sanyal
    • 1
  • Tyralee Goo
    • 1
  • Ariel A. Benson
    • 1
  • Carol A. Bodian
    • 2
  • Kenneth M. Miller
    • 1
  • Lawrence B. Cohen
    • 1
  • James Aisenberg
    • 1
  1. 1.Department of Medicine (Gastroenterology)The Mount Sinai School of MedicineNew YorkUSA
  2. 2.Department of Anesthesiology (Biostatistics)The Mount Sinai School of MedicineNew YorkUSA