NONSTEROIDAL ANTIINFLAMMATORY DRUGS AND UPPER GASTROINTESTINAL-BLEEDING, IDENTIFYING HIGH-RISK GROUPS BY EXCESS RISK ESTIMATES

Background: The relationship between use of nonsteroidal anti-inflamma tory drugs (NSAID) and severe upper gastrointestinal bleeding (UGB) ha s been established beyond reasonable doubt. The literature on risk fac tors has almost exclusively focused on comparisons of relative risks i n subgroups of patients: men versus women, old versus young and so for th. However, from a pragmatic, clinical viewpoint, only the excess ris k provides a meaningful, robust measure of the magnitude of risk facto rs. The purpose of the study was to determine the excess risks in subg roups of patients and to characterize the utilization pattern of NSAID s. Methods: A registry-based cohort study was conducted in a prescript ion and diagnosis registry in Odense, which covered a population of 20 7,000 persons for a period of 19 months. Results: In total, 183 (113 m en and 70 women) UGB patients were identified, of whom 37 were current users of NSAIDs. The standardized incidence rate of UGB was 46 per 10 0,000 person-years for nonexposed and 253 per 100,000 person-years for exposed person-time, yielding an excess risk of 207 per 100,000 perso n-years (confidence interval (CI), 132-319) and a standardized inciden ce ratio (SIR) of 5.5 (CI, 3.9-7.9). Men had a higher excess risk than women (277 versus 150 per 100,000 person-years). The SIR decreased wi th increasing duration of exposure. The excess risk was particularly h igh in persons aged 75 years or more (1258 per 100,000 person-years) a nd in patients with a history of peptic ulcer (879 per 100,000 person- years), being about 10- and 5-fold higher than in the complementary gr oups. NSAID utilization was remarkably sporadic. We found 31,503 users and a median purchase of 20 defined daily doses. Shortterm use was hi ghly prevalent in all age groups. Women, the elderly, and persons with a history of ulcer had a higher prevalence of NSAID use than others. Conclusions: A history of peptic ulcer is associated with adverse outc ome of NSAID therapy and should be regarded as a relative contraindica tion. A similarly strong effect of high age was shown. Male sex and sh ort-term use are minor risk factors. The incidence of NSAID-related UG B can probably be reduced without affecting the overall utilization of NSAIDs.