Cyclooxygenase-2 specific inhibitors and upper gastrointestinal tolerability in patients with osteoarthritis receiving concomitant low dose aspirin: pooled analysis of 2 trials.

OBJECTIVE

To evaluate the relative gastrointestinal (GI) tolerability of celecoxib and rofecoxib in elderly hypertensive patients with osteoarthritis (OA) with or without coadministration of low dose aspirin (ASA) (< or = 325 mg daily).

METHODS

Two independently conducted, multicenter, double blind, randomized controlled trials designed to evaluate GI tolerability, in addition to cardiorenal study endpoints, in patients randomized to celecoxib 200 mg once daily (qd; n = 960) or rofecoxib 25 mg qd (n = 942) were analyzed. GI tolerability was assessed using investigator-reported GI symptoms, prespecified as abdominal pain, dyspepsia, and nausea. The pooled incidences of the 3 reported GI symptoms, regardless of severity (mild and moderate to severe), and the incidences of mild or moderate to severe GI symptoms individually were evaluated.

RESULTS

In the pooled population, the incidence of the 3 GI symptoms, regardless of severity, was not significantly different for patients receiving celecoxib or rofecoxib. In contrast, the aggregate incidence of moderate to severe GI symptoms for patients receiving rofecoxib (5.2%) was significantly greater than for those receiving celecoxib (3.2%; p < 0.05). Notably, the significant difference between the 2 arms was more pronounced in the population of patients receiving concomitant low dose ASA (rofecoxib 9.7% vs celecoxib 1.5%; p < 0.001). The incidence of moderate to severe GI symptoms was similar with rofecoxib (3.3%) and celecoxib (3.9%; p = 0.564) treatment in patients who did not receive low dose ASA.

CONCLUSIONS

While the GI tolerability was similar in the 2 arms of the entire pooled population, celecoxib 200 mg qd was associated with a significantly lower incidence of moderate to severe GI symptoms than rofecoxib 25 mg qd in patients receiving concomitant low dose ASA.