Abstract
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. CONCLUSION: 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.
