Nonsteroidal anti-inflammatory drug-associated gastropathy: incidence and risk factor models

Am J Med. 1991 Sep;91(3):213-22. doi: 10.1016/0002-9343(91)90118-h.


Purpose: The most prevalent serious drug toxicity in the United States is increasingly recognized as gastrointestinal (GI) pathology associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs). The incidence of serious GI events (hospitalization or death) associated with NSAID use was therefore prospectively analyzed in patients with rheumatoid arthritis (RA) and patients with osteoarthritis.

Patients, methods, and results: The study consisted of 2,747 patients with RA and 1,091 patients with osteoarthritis. The yearly hospitalization incidence during NSAID treatment was 1.58% in RA patients and was similar in all five populations studied. The hazard ratio of patients taking NSAIDs to those not taking NSAIDs was 5.2. The incidence in osteoarthritis may be less. The risk of GI-related death in RA patients was 0.19% per year with NSAIDs. Multivariate analyses assessing risk factors for serious GI events were performed in the 1,694 (98 with an event) RA patients taking NSAIDs at the predictive visit. The main risk factors were higher age, use of prednisone, previous NSAID GI side effects, prior GI hospitalization, level of disability, and NSAID dose. A rule is presented that allows estimation of the risk for the individual patient with RA.

Conclusion: Knowledge of the risk factors for NSAID-associated gastropathy and their inter-relationships provides a tool for identification of the patient at high risk and for initiation of appropriate therapeutic action.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Analysis of Variance
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Arthritis, Rheumatoid / drug therapy
  • Drug Therapy, Combination
  • Gastrointestinal Diseases / chemically induced*
  • Gastrointestinal Diseases / mortality
  • Hospitalization
  • Humans
  • Incidence
  • Middle Aged
  • Odds Ratio
  • Osteoarthritis / drug therapy
  • Prednisone / adverse effects
  • Prospective Studies
  • Regression Analysis
  • Risk Factors


  • Anti-Inflammatory Agents, Non-Steroidal
  • Prednisone