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The PRECISION study took 11 years and 24,081 patients (90% OA; 10% RA). It showed that celecoxib had fewer gastrointestinal events, fewer renal events and less ATPC cardiac events compared to ibuprofen - with an 18% reduction in major CV events and a 32% reduction in all-cause mortaility compared to ibuprofen.
Since 45% of patients received background low-dose daily aspirin, further study of the effects of ASA cotherapy was undertaken in a substudy published in the Journal of the American College of Cardiology.
When taken without aspirin, naproxen or ibuprofen had greater risk for the primary composite endpoint compared with celecoxib (hazard ratio [HR]: 1.52; 95% confidence interval [CI]: 1.22 to 1.90, p <0.001; and HR: 1.81; 95% CI: 1.46 to 2.26; p <0.001, respectively). Compared with celecoxib, ibuprofen had more major adverse cardiovascular events (p < 0.05), and both ibuprofen and naproxen had more gastrointestinal (p < 0.001) and renal (p < 0.05) events.
When low-dose aspirin was taken, ibuprofen still had greater risk of achieving for the primary composite endpoint compared with celecoxib, but the hazard ratio [HR] dropped from 1.52 (without ASA) to HR 1.27 (with ASA).
Among patients on aspirin, major adverse cardiovascular events were similar among NSAIDs, and compared with celecoxib, ibuprofen had more gastrointestinal and renal events (p < 0.05), while naproxen had more gastrointestinal events (p < 0.05), without a difference in renal events.
Celecoxib, taken without ASA, had a more favorable overall safety profile than naproxen or ibuprofen. Adding aspirin attenuates the safety advantage of celecoxib, although celecoxib is still associated with fewer gastrointestinal events than ibuprofen or naproxen and fewer renal events than ibuprofen.
The safety of NSAIDs and their combined use with ASA will be considered further with combined hearings of the FDA arthritis advisory and drug safety advisory committees on Tuesday (24 April) and Wednesdy (25 April).