NEJM publishes long-awaited results of celecoxib safety trial
The long-awaited results of a major trial set up to investigate the cardiovascular risks of celecoxib indicate the drug is safe compared with non-selective NSAIDs.
The randomised controlled trial involving 24,000 osteoarthritis patients set up in the wake of the withdrawal of rofecoxib in 2004 has found that celecoxib has a similar cardiovascular safety profile compared with ibuprofen and naproxen
The PRECISION trial, which started in 2006, found that moderate doses of celecoxib (200mg daily) are non-inferior in terms of major cardiovascular events compared with ibuprofen or naproxen.
As expected, the trial showed that gastrointestinal events were less common with the COX-2 inhibitor, but also that renal safety appeared to be good compared with naproxen.
"After the withdrawal of rofecoxib everybody thought they knew the answer; that COX-2 inhibitors have an unfavourable cardiovascular profile,