Pooled analysis of thrombotic cardiovascular events in clinical trials of the COX-2 selective inhibitor etoricoxib

Background: A pooled analysis of randomized clinical trials data was performed to compare the rate of thrombotic cardiovascular events ( thrombotic events) in patients taking the COX-2 selective inhibitor ( coxib) etoricoxib, a traditional NSAID, or placebo. Methods: Data collected during all phase IIb/III etoricoxib clinical trials >= 4 weeks in duration were evaluated. The pooled data set includes clinical information from approximate to 6500 patient-years ( PYs) of drug exposure in patients diagnosed with rheumatoid arthritis ( RA), osteoarthritis ( OA), ankylosing spondylitis ( AS), or chronic low back pain ( CLBP). Patients were treated with either etoricoxib (>= 60 mg/day), the traditional NSAIDs naproxen ( 1000 mg/day), ibuprofen ( 2400 mg/ day), diclofenac ( 150 mg/ day), or placebo. The Relative risks ( RRs) based on time to first occurrence of a thrombotic event in the etoricoxib group versus the comparator traditional NSAIDs or versus placebo were determined using patient-level data. Results: In the pooled dataset, a total of 74 thrombotic events occurred in 69 patients. The RRs for thrombotic events were 1.11 ( 95% CI: 0.32, 3.81) for etoricoxib ( N = 2818) versus placebo ( N = 1767); 0.83 ( 95% CI: 0.26, 2.64) for etoricoxib ( N = 1266) versus the combined non-naproxen traditional NSAID group ( ibuprofen and diclofenac; N = 718); and 1.70 ( 95% CI: 0.91, 3.18) for etoricoxib ( N = 1960) versus naproxen ( N = 1497). Conclusions: There was no discernible difference in the incidence of thrombotic events in patients treated with etoricoxib versus non-naproxen traditional NSAIDs in this limited dataset. naproxen A trend toward more events with etoricoxib versus naproxen was observed. Despite the limited dataset available for this pooled analysis, these results are consistent with findings for other coxibs.