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


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.


CONCLUSIONS
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.
Fries
J F
JF
Department of Medicine, Stanford University School of Medicine, California.
Williams
C A
CA
Bloch
D A
DA
Michel
B A
BA
D000328:Adult; D000367:Age Factors; D000368:Aged; D000704:Analysis of Variance; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy; D004359:Drug Therapy, Combination; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000401:mortality; D006760:Hospitalization; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D016017:Odds Ratio; D010003:Osteoarthritis / Q000188:drug therapy; D011241:Prednisone / Q000009:adverse effects; D011446:Prospective Studies; D012044:Regression Analysis; D012307:Risk Factors
D000894:Anti-Inflammatory Agents, Non-Steroidal; D011241:Prednisone