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On the basis of relevant clinical studies performed so far, selective COX-2 inhibitors exhibit a therapeutic advantage over conventional NSAIDs with regard to the incidence of gastrointestinal (GI) damage such as perforation, ulceration, and bleeding (PUBs). The results prove that a risk reduction could be demonstrated during long-term treatment (6-9 months); nevertheless, PUBs cannot be ruled out under treatment with selective COX-2 inhibitors. In contrast to this, dyspeptic symptoms occur very frequently and their incidence is comparable to that of conventional NSAIDs. The increased incidence of thromboembolic, cardiovascular events documented in the VIGOR study for rofecoxib versus naproxen was not confirmed by comparison to placebo and other NSAIDs in additional clinical studies. In clinical studies no clear signs of thrombotic effects have been described for the therapeutic administration of celecoxib. Based on preclinical investigations as well as on the thromboembolic, cardiovascular events reported in connection with the therapeutic use of COX-2 inhibitors, safety measures are necessary and further investigations are recommended.