PRECISION: Is Celecoxib Non-Inferior to Ibuprofen or Naproxen?
Celecoxib may be non-inferior to ibuprofen or naproxen in small doses, according to the results of the PRECISION Trial presented Nov. 13 during AHA 2016 and simultaneously published in the New England Journal of Medicine.
In a randomized, double-blind, multicenter trial, Stephen E. Nissen, MD, MACC, a past-president of the ACC, et al., evaluated the composite outcomes of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke in 24,081 patients receiving celecoxib, ibuprofen or naproxen. Participants required nonsteroidal anti-inflammatory drugs for osteoarthritis or rheumatoid arthritis and were at increased cardiovascular risk.
The results of the trial show that at the mean follow-up of 34 months of the intention-to-treat analyses, a primary outcome event occurred in 2.3 percent of patients taking celecoxib, 2.5 percent of those taking naproxen and 2.7 percent of those taking ibuprofen. Further, the risk of gastrointestinal events was significantly lower in the celecoxib group than in the naproxen or ibuprofen groups.
In an editorial comment simultaneously published in Circulation, Garret A. FitzGerald, MD, notes that "there are so many problems with the interpretation of [the PRECISION trial] that it fails to inform clinical practice. Thus, despite the enrollment of > 24,000 patients and more than a decade of study, we are no closer to being able to advise the millions of patients with chronic arthritic pain regarding relative efficacy and safety of the treatments available to them."
Keywords: AHA16, American Heart Association, AHA Annual Scientific Sessions, Acute Coronary Syndrome, Angina, Stable, Anti-Inflammatory Agents, Non-Steroidal, Cardiovascular Diseases, Cyclooxygenase Inhibitors, Ibuprofen, Naproxen, Pyrazoles, Risk Factors
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