Gastrointestinal Tract Complications of Nonsteroidal Anti-inflammatory Drug Treatment in Rheumatoid Arthritis: A Prospective Observational Cohort Study

doi:10.1001/archinte.1996.00440130066007

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Vol. 156 No. 14, 22 JULY 1996

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Gastrointestinal Tract Complications of Nonsteroidal Anti-inflammatory Drug Treatment in Rheumatoid Arthritis

A Prospective Observational Cohort Study

Gurkirpal Singh, MD; Dena Rosen Ramey; Dianne Morfeld; Hong Shi, MS; Hind T. Hatoum, PhD; James F. Fries, MD

Arch Intern Med. 1996;156(14):1530-1536.

Abstract

Background
Gastrointestinal tract (GI) complications associated with nonsteroidalanti-inflammatory drug (NSAID) use are the most common seriousadverse drug reactions in the United States. Nonsteroidal antiinflammatorydrugs cause both minor GI side effects such as abdominal painand vomiting and serious GI events such as ulcers and bleeding.This study evaluates the event rates for all NSAID-induced GIcomplications in patients with rheumatoid arthritis, describesthe time course of these events, and evaluates the role of prophylactictherapy with antacids and H₂ receptor antagonists.

Methods
We studied 1921 patients with rheumatoid arthritis from 8 ARAMIS(Arthritis, Rheumatism, and Aging Medical Information System)centers. Patients were selected for the study if they were treatedwith NSAIDs and had at least 2.5 years of observation available.Information on GI complications attributed to NSAIDs was obtainedfrom validated patient self-reports collected every 6 monthsand supplemented by review of hospital records for all hospitalizations.

Results
Approximately 15% of the 1921 patients reported an NSAID-inducedGI side effect during the 2.5-year observation period. Forty-twopatients had a serious GI complication requiring hospitalization;34 of these 42 patients did not have a preceding GI side effect.Patients who were taking antacids and H₂ receptor antagonistsdid not have a significantly lower risk for serious GI complicationsthan did those not taking such medications. Asymptomatic patientstaking these medications had a significantly higher risk forGI complications compared with those who did not take thesemedications (standardized odds ratio, 2.14; 95% confidence interval,1.06-4.32).

Conclusions
A large majority of patients with serious GI complications donot have preceding mild side effects. Prophylactic treatmentwith antacids and H₂ receptor antagonists is of questionablevalue and may increase the risk for subsequent serious GI complications.

Arch Intern Med. 1996;156:1530-1536

Author Affiliations

From the Department of Medicine, Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, Calif (Drs Singh and Fries and Mss Ramey, Morfeld, and Shi), and G. D. Searle & Co, Skokie, Ill (Dr Hatoum).

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