The medical literature describing the gastrointestinal risks associated with chronic nonsteroidal anti-inflammatory drug (NSAID) therapy is increasing rapidly. In spite of this, clinicians remain uncertain about how to translate this information into clinical practice. Clinical decisions regarding the management of adverse reactions to medications have two components. The first involves risk to the patient, and the second an evaluation of available alternatives for managing that risk. Three research designs have been used to examine this association: ecological studies, case control studies and retrospective cohort studies. Although these designs do not provide the strongest evidence for causation, their results point toward the existence of a risk of serious gastrointestinal reactions of between 1.5 and 10 times greater for NSAID users than for nonusers. The wide variation in results is due to multiple factors, including different research designs, study populations and outcome measures. Several subgroups have been suggested to be at particularly high risk. Risk factors include advanced age, female sex, debilitating rheumatoid disease, previous gastrointestinal disease, ethanol abuse and smoking. Only in the elderly has there been adequate data to support this association. Although the data regarding females is compelling, this may be confounded by the documented increased NSAID use among females. Decision analysis is a useful tool for the quantitative examination of the costs and benefits of management alternatives available for dealing with these risks. Research is needed to identify accurately subgroups of NSAID users at high risk.
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