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 > or = 4 weeks in duration were evaluated. The pooled data set includes clinical information from approximately 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 (> or = 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. 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.
Curtis
Sean P
SP
Merck Research Laboratories, Rahway, NJ 07065, USA.
Ko
Amy T
AT
Bolognese
James A
JA
Cavanaugh
Paul F
PF
Reicin
Alise S
AS
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects*; D004008:Diclofenac / Q000009:adverse effects; D000077613:Etoricoxib; D006801:Humans; D010003:Osteoarthritis / Q000188:drug therapy; D011725:Pyridines / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D013450:Sulfones / Q000009:adverse effects*; D013927:Thrombosis / Q000139:chemically induced* / Q000453:epidemiology
D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D011725:Pyridines; D013450:Sulfones; D004008:Diclofenac; D000077613:Etoricoxib