Each year in the U.S., cardiovascular disease claims more lives than the next seven leading causes of mortality combined. During 1999, it was estimated that more than 59 million Americans had one or more types of cardiovascular disease; in 1996 (the most recent year for which statistics are available), cardiovascular disease had been at least a contributing factor in the deaths of 1.4 million individuals. Myocardial infarction is the primary cause of cardiovascular event-related death, with a substantial proportion of these events occurring in middle-aged adults. The risk for women is similar to that for men.

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During the past two decades, numerous studies have quantified the relative risk for the development of gastrointestinal injury in patients receiving aspirin or nonselective COX-1/COX-2 NSAIDs.

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Gastrointestinal side effects associated with NSAID and aspirin use range in severity from minor, superficial mucosal injury to ul-ceration, perforation, gastric outlet obstruction, and hemorrhage. These effects represent a substantial source of drug-induced morbidity and mortality among Americans. Hospitalizations resulting from gastrointestinal disorders are at least six times more frequent in patients with arthritis who are taking NSAIDs compared with patients who are not. Up to 20% of patients taking long-term traditional NSAIDs have gastroduodenal ulcers, which can be observed by endoscopy; between 2% and 4% have symptomatic gastric ulcers; and between 1% and 2% have ulcer complications.

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The physiological reaction to injury, noxious agents, and autoimmune-triggered substances consists of an innate, non-immunologic response and an acquired, specific immune re-sponse. During this highly complex repertoire of responses, referred to as the inflammatory reaction (Figure 1), numerous mediators of inflammation (e.g., eicosanoids, histamine, platelet-activating factor [PAF], bradykinin, and cytokines) are synthesized or released. Of these, the eicosanoids (e.g., prostaglandins, prostacyclin [PGI₂], thromboxane A₂, and leukotrienes) are derived from arachidonate by either cy-clooxygenase (COX) or lipoxygenase and are considered among the most important mediators and modulators of the inflammatory reaction as well as key factors in the physiological regulation of vascular and renal homeostasis.

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