GASTROINTESTINAL-TRACT COMPLICATIONS OF NONSTEROIDAL ANTIINFLAMMATORYDRUG-TREATMENT IN RHEUMATOID-ARTHRITIS - A PROSPECTIVE OBSERVATIONAL COHORT STUDY

Background: Gastrointestinal tract (GI) complications associated with nonsteroidal anti-inflammatory drug (NSAID) use are the most common se rious adverse drug reactions in the United States. Nonsteroidal antiin flammatory drugs cause both minor GI side effects such as abdominal pa in and vomiting and serious GI events such as ulcers and bleeding. Thi s study evaluates the event rates for all NSAID-induced GI complicatio ns in patients with rheumatoid arthritis, describes the time course of these events, and evaluates the role of prophylactic therapy with ant acids and H-2 receptor antagonists. Methods: We studied 1921 patients with rheumatoid arthritis from 8 ARAMIS (Arthritis, Rheumatism, and Ag ing Medical Information System) centers. Patients were selected for th e study if they were treated with NSAIDs and had at least 2.5 years of observation available. Information on GI complications attributed to NSAIDs was obtained from validated patient self-reports collected ever y 6 months and supplemented by review of hospital records for all hosp italizations. Results: Approximately 15% of the 1921 patients reported an NSAID-induced CI side effect during the 2.5-year observation perio d. Forty-two patients had a serious GI complication requiring hospital ization; 34 of these 42 patients did not have a preceding CTI side eff ect. Patients who were taking antacids and H-2 receptor antagonists di d not have a significantly lower risk for serious GI complications tha n did those not taking such medications. Asymptomatic patients taking these medications had a significantly higher risk for GI complications compared with those who did not take these medications (standardized odds ratio, 2.14; 95% confidence interval, 1.06-4.32). Conclusions: A large majority of patients with serious CI complications do not have p receding mild side effects. Prophylactic treatment with antacids and H -2 receptor antagonists is of questionable value and may increase the risk for subsequent serious GI complications.