Results of the landmark PRECISION ( Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen Or Naproxen ) trial demonstrated similar rates of cardiovascular risk in patients treated with prescription doses of Celecoxib ( Celebrex ), Ibuprofen and Naproxen who had a clinical diagnosis of osteoarthritis or rheumatoid arthritis, were at high risk for cardiovascular disease, and required daily treatment with non-steroidal anti-inflammatory drugs ( NSAIDs ) to control symptoms of arthritis.
In addition, patients treated with Celecoxib experienced significantly fewer gastrointestinal events as compared with those receiving prescription doses of Ibuprofen or Naproxen.
The results of the PRECISION study were presented at the Annual meeting of the American Heart Association ( AHA ) in New Orleans.
In addition, the results were published today in the New England Journal of Medicine ( NEJM ).
PRECISION was a prospective, long-term non-inferiority trial of 24,081 patients designed to assess the cardiovascular safety of Celecoxib versus prescription strength doses of Ibuprofen and Naproxen in patients with chronic pain from OA or RA.
The trial, designed in 2005 based on discussions with the U.S. Food and Drug Administration, was funded by Pfizer but directed independently by the Cleveland Clinic and governed by an executive committee composed of cardiology, gastroenterology, and rheumatology specialists.
Questions about the cardiovascular safety of prescription NSAIDs have persisted since the withdrawal of Vioxx ( Rofecoxib ) from the market in 2004.
The study demonstrated that patients treated with prescription doses of Celecoxib, Ibuprofen or Naproxen had similar rates of cardiovascular events and dispels the long held perception of excess cardiovascular risk associated with long term use of Celecoxib.
The primary objective of PRECISION was to assess the effects of Celecoxib ( 100-200 mg twice daily ) compared to prescription strength doses of Ibuprofen ( 600-800 mg three times a day ) or Naproxen ( 375-500mg twice a day ) on the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke in subjects with OA or RA and who have established cardiovascular disease or risk factors for cardiovascular disease.
Pre-specified secondary objectives including assessments of additional cardiovascular endpoints, significant gastrointestinal events, renal events and arthritis pain improvement will be published at a later date.
All subjects were provided with Esomeprazole, a proton pump inhibitor, to be taken once daily as a gastro-protective agent. Patients also had the option of continuing low-dose Aspirin for additional cardio-protective effects regardless of their cardiovascular risk.
The final PRECISION trial results have provided statistically strong evidence that cardiovascular risk with approved doses of Celecoxib is not greater than that of prescription doses of Ibuprofen and Naproxen.
The study showed that patients with chronic arthritic conditions and cardiovascular risk factors taking Celecoxib experienced numerically fewer cardiovascular events as compared to patients receiving prescription strength doses of Ibuprofen and Naproxen.
More specifically, a primary endpoint occurred in 2.3% of patients receiving Celecoxib as compared to 2.5% for patients receiving Naproxen and 2.7% for patients receiving Ibuprofen.
In addition, regarding secondary analyses, significantly fewer gastrointestinal events occurred among patients treated with Celecoxib as compared with those receiving prescription doses of either Ibuprofen or Naproxen.
More specifically, serious gastrointestinal events occurred in 1.1% of patients receiving Celecoxib as compared to 1.5% for patients receiving prescription doses of Naproxen and 1.6% for patients receiving prescription doses of Ibuprofen.
The gastrointestinal safety findings were observed despite providing all patients enrolled in the study with a proton pump inhibitor to reduce stomach acids.
In addition, the secondary endpoint involving renal events occurred with a lower frequency in patients treated with Celecoxib as compared to prescription doses of Ibuprofen. ( Xagena )
Source: Pfizer, 2016