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<p>However, promising report not without its critics.</p>

Notable COX-2 Inhibitor Carries Same CV Risks as Traditional NSAIDs

December 8, 2016

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Celecoxib (Celebrex) has similar cardiovascular risks as traditional NSAIDs, according to a new industry-sponsored study. Celebrex is a COX-2 inhibitor, similar to rofecoxib (Vioxx) and valdecoxib (Bextra), which were both removed from the market in 2004 and 2005 due to excess cardiovascular events. Celecoxib also has been implicated in an increased rate of cardiovascular events compared to placebo, but to a lesser extent than the other COX-2 drugs. A new study compared celecoxib to the non-selective NSAIDs ibuprofen and naproxen in patients at risk for cardiovascular disease to assess cardiovascular safety. More than 24,000 patients presenting with rheumatoid arthritis or osteoarthritis were randomly assigned to celecoxib 100 mg twice a day, naproxen or ibuprofen for a mean treatment duration of 20 months and a mean follow-up period of 34 months with a primary outcome of fatal cardiovascular events or nonfatal stroke or myocardial infarction. Nearly 70% stopped taking the trial drug during the study, and 27% discontinued follow-up. In the intention-to-treat analyses, a primary outcome event occurred in 2.3% of patients in the celecoxib group, 2.5% in the naproxen group, and 2.7% in the ibuprofen group (hazard ratio [HR] for celecoxib vs. naproxen, 0.93; 95% confidence interval [CI], 0.76-1.13; HR for celecoxib vs. ibuprofen, 0.85; 95% CI, 0.70-1.04; P < 0.001 for noninferiority in both comparisons). The results were similar in the on-treatment analysis (P < 0.001 for noninferiority for both comparisons). The risk of gastrointestinal events was significantly lower with celecoxib than with naproxen (P = 0.01) or ibuprofen (P = 0.002); the risk of renal events was significantly lower with celecoxib than with ibuprofen (P = 0.004), but was not significantly lower with celecoxib than with naproxen (P = 0.19). (doi: 10.1056/NEJMoa1611593). In a fairly strident critique, Dr. Garret Fitzgerald suggested the study was poorly designed and that “there are so many problems with the interpretation of PRECISION that it fails to inform clinical practice.” (Circulation. Published online Nov. 13, 2016. http://dx.doi.org/10.1161/CIRCULATIONAHA.116.026324.)