Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are often prescribed in patients with rheumatoid arthritis (RA). Because of its frequency and severity, NSAID gastropathy is the most important side effect. The clinical spectrum of NSAID gastropathy includes gastrointestinal complaints, ulcers and their complications. To reduce NSAID gastropathy, rheumatologists in greater Amsterdam decided in January 1997 that prophylactic agents should be prescribed for patients with RA at high risk for NSAID gastropathy, defined as age 60 or older or a history of gastrointestinal (GI) ulcers, or both.
Objective: To determine the incidence of clinically manifest ulcers and their complications in patients with RA at high risk for NSAID gastropathy during a period in which prophylaxis was recommended. Published reports show that the incidence of clinically manifest ulcers and their complications varies from 1.3% to 5%.
Patients and methods: Within one year, three questionnaires were sent to all outpatients with RA of our clinic (n=2680). The patients were asked if they had had a gastroscopy and/or complication of an ulcer in the preceding months. When a GI event (ulcer or complication) had occurred an analysis was carried out to determine whether the event was possibly related to a compliance failure or a policy failure-for example, no prophylaxis prescribed when it was recommended.
Results: The response rate for the three questionnaires was 88%, 76%, and 77%, respectively. All three questionnaires were returned by 1856 patients; NSAIDs were used in 1246 (67%) of them. Of the NSAID users 731 (59%) were in the high risk group. Clinically manifest ulcers occurred in seven high risk NSAID users (four gastric ulcers, two duodenal ulcers, and in one patient both types of ulcer). Complications of ulcers were diagnosed in eight (other) patients: seven (upper) GI bleedings and one perforation. Thus the incidence during one year of clinically manifest ulcers in the high risk group was 1.0% and of complications of ulcers 1.1%, together 2.1%. In the group of 15 patients with GI events, only one patient had not taken the adequately prescribed gastroprotective drugs (compliance failure). Misguidedly, gastroprotective drugs were not prescribed in seven patients (policy failure), but in the remaining seven patients gastroprotective drugs were adequately prescribed and used.
Conclusion: The incidence of clinically manifest ulcers and of complications of ulcers in patients with RA at high risk for NSAID gastropathy is relatively low, and might be related to our strategy to prescribe prophylactic agents in these patients.