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

Research output: Contribution to journalArticlepeer-review

12 Scopus citations

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.

Original languageEnglish
Pages (from-to)2059-2065
Number of pages7
JournalDigestive Diseases and Sciences
Volume53
Issue number8
DOIs
StatePublished - Aug 2008

Keywords

  • Anti-ulcer agents
  • Dyspepsia
  • Non-steroidal anti-inflammatory agents
  • Peptic ulcer
  • Primary prevention
  • Proton pump inhibitors

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