6 In addition, the PRECISION trial found lower risk of serious gastrointestinal (GI) events for celecoxib versus naproxen and ibuprofen and lower risk of renal events for celecoxib versus ibuprofen in the intention-to-treat population of the trial. The trial demonstrated that celecoxib was similar in terms of cardiovascular safety when compared with ibuprofen and naproxen in the pooled PRECISION population of 24,081 patients with osteoarthritis (~90%) or rheumatoid arthritis (~10%). 6 The mean durations of treatment and follow-up, respectively, were 20.8☑6.0 and 34.2☑3.4 months in the celecoxib group, 20.5☑5.9 and 34.2☑3.3 months in the naproxen group, and 19.6☑6.0 and 33.8☑3.6 months in the ibuprofen group. Patients were randomly assigned, in a 1:1:1 ratio, to receive celecoxib (100 mg twice a day), ibuprofen (600–800 mg three times a day), or naproxen (375–500 mg twice a day). To highlight the importance of having head-to-head comparison with regard to safety outcomes of the COX-2 inhibitor celecoxib, the Food and Drug Administration (FDA) mandated the conduct of the cardiovascular safety trial Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen or Naproxen (PRECISION) as Phase IV post-marketing surveillance.
2 While COX-2 inhibitors have been correlated with evidence of adverse cardiovascular outcomes at higher doses in placebo-controlled trials, 3, 4 data from meta-analyses of observational studies have suggested that the use of traditional NSAIDs is also not free of cardiovascular and renal risk and that this risk may not be entirely attributed to COX-2 selectivity. 1 Selective COX-2 inhibitors such as celecoxib reduce pain effectively while decreasing the incidence of gastrointestinal adverse effects compared with ns- NSAIDs such as ibuprofen and naproxen. Pain management via traditional non-selective non-steroidal anti-inflammatory drugs (ns-NSAIDs) and selective cyclooxygenase-2 (COX-2) inhibitors is an effective treatment for patients in the Middle East and North Africa (MENA) and Gulf regions.