The PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial was a landmark study aimed at evaluating the cardiovascular safety of celecoxib compared to two other commonly used nonsteroidal anti-inflammatory drugs (NSAIDs): ibuprofen and naproxen.
Here are the key findings of the PRECISION trial:
- Cardiovascular Safety: Celecoxib was found to be non-inferior to both naproxen and ibuprofen in terms of cardiovascular risk. This means that celecoxib did not demonstrate a higher risk of major adverse cardiovascular events (e.g., cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) compared to the other two NSAIDs.
- Gastrointestinal Safety: Celecoxib showed a statistically significant lower risk of gastrointestinal bleeding compared to both ibuprofen and naproxen.
- Renal Adverse Events: The use of celecoxib was associated with a lower risk of renal adverse events compared to ibuprofen, but its risk was not significantly different from that of naproxen.
- All-cause Death, Myocardial Infarction, or Stroke: No significant difference was observed among the three NSAIDs in terms of a combined endpoint of all-cause death, myocardial infarction, or stroke.
- Blood Pressure: Celecoxib had a less adverse effect on blood pressure compared to ibuprofen.
It’s important to note the following regarding the PRECISION trial:
- All participants in the trial had either established cardiovascular disease or were at increased risk for it.
- The doses of NSAIDs used were at the higher end of their respective recommended ranges: celecoxib (100–200 mg twice daily), ibuprofen (600–800 mg three times daily), and naproxen (375–500 mg twice daily).
- The results were somewhat unexpected, as there had been concerns about the cardiovascular safety of celecoxib due to its mechanism of action as a selective COX-2 inhibitor. The trial was initially designed to assess whether celecoxib would have increased cardiovascular risks compared to naproxen and ibuprofen.
In conclusion, the PRECISION trial provided valuable data suggesting that celecoxib, when used in appropriate patients and at the studied doses, had cardiovascular safety comparable to ibuprofen and naproxen and might offer some advantages in terms of gastrointestinal and renal safety. As always, individual patient factors and risks should be considered when selecting an NSAID for therapy.