Celecoxib is no more likely to cause cardiovascular events than ibuprofen or naproxen, the PRECISION trial has found
Before this trial, the cardiovascular safety of celecoxib as compared with nonselective nonsteroidal anti-inflammatory drugs had been uncertain.
But the 10-year randomised, multicentre, double-blind, noninferiority PRECISION trial, which involved over 24,000 patients who were at increased cardiovascular risk and had rheumatoid arthritis or osteoarthritis, showed that moderate doses of celecoxib are just as safe as naproxen or ibuprofen with regard to cardiovascular safety.
Celecoxib treatment also resulted in lower rates of gastrointestinal events than did either comparator drug and in lower rates of renal adverse events than did ibuprofen.
The PRECISION trial was mandated by the US FDA following the withdrawal of rofecoxib (Vioxx) from the market in 2004, to determine if celecoxib shared a similar increased risk of heart-related complications.
Heart attack, stroke or death occurred in 2.3% of patients taking celecoxib, 2.5% of patients taking naproxen, and 2.7% of patients taking ibuprofen.
PRECISION also assessed a broader measure of cardiovascular safety, the primary outcome – heart attack, stroke or death – plus hospitalisation for unstable angina or coronary revascularisation (stenting or bypass).
It showed a 15% higher risk for ibuprofen than celecoxib, but this difference was borderline in statistical significance.
However it did find a statistically significant 64% higher risk of worsening kidney function for ibuprofen compared with celecoxib.
Numerically more kidney complications occurred with naproxen, but the difference was not statistically significant. Death from any cause was approximately 25% higher with naproxen than celecoxib, but this difference was borderline in statistical significance.
“The trial’s primary message is that celecoxib is not riskier for the heart than other NSAIDs,” says Dr Nissen, who cautioned against over-interpretation of these findings.
“The PRECISION trial studied full prescription doses of these drugs, not the lower doses available in over-the-counter preparations. The safety findings may or may not apply to the typical intermittent use of lower doses of these drugs by many patients.”