NSAID-associated dyspepsia and ulcers: a prospective cohort study in primary care

BACKGROUND AND AIM: Nonsteroidal anti-inflammatory drugs (NSAIDs) cause dyspeptic complaints and lesions in the upper gastrointestinal tract. The true incidence of these side effects in the everyday situation remains uncertain. We therefore investigated as to how often patients on NSAIDs in the primary care setting must be expected to develop troublesome dyspepsia and/or ulcers in the upper gastrointestinal tract. PATIENTS AND METHODS: Admitted to the study were consecutive patients requiring NSAID treatment for at least 2 weeks, who were free of treatment-requiring dyspeptic symptoms, and who were not receiving any prophylactic co-medication. After a minimum of 2 weeks of treatment with a NSAID, a standardized questionnaire and endoscopy of the upper gastrointestinal tract were obtained. RESULTS: 104 patients (median age 53 years, 91 women) were recruited to the study. Four patients had to be excluded for protocol violations. NSAID treatment was applied mainly with diclofenac (n = 67), followed by ibuprofen (n = 22) and rofecoxib (n = 9). The main indication was degenerative complaints affecting the vertebral column and joints. Under treatment, 35% of the patients developed troublesome dyspepsia that required treatment. The frequency of dyspepsia was independent of the duration of NSAID use. Ulcer prevalence was 16% (duodenal ulcer: n = 5; gastric ulcer: n = 11; cardiac ulcer: n = 1). Relevant epigastric pain was experienced more frequently by ulcer patients than those with no ulcer (35 vs. 18%, p = n.s.), but their overall symptom frequency was no higher than in the latter. Predictors for the development of ulcer were smoking (odds ratio 5.11 [1.59-16.48]), regular use of alcohol (odds ratio 4.49 [1.34-15.07]) and duration of treatment less than 1 month (odds ratio 4.95 [1.06-23.09]). No ulcer complications occurred during the period under observation. Overall, 44% of the patients developed troublesome dyspepsia and/or ulcer. CONCLUSION: Primary care patients with an average risk profile frequently develop dyspeptic symptoms requiring treatment, and ulcers while on NSAIDs. Patients who developed an ulcer were not identifiable on the basis of symptoms or risk factors.