Results of the landmark Prospective Randomized Evaluation of CelecoxibIntegrated Safety vs. Ibuprofen Or Naproxen (PRECISION) demonstrated similar rates of cardiovascular risk in patients treated with prescription doses of celecoxib, ibuprofen and naproxen who had a clinical diagnosis of osteoarthritis (OA) or rheumatoid arthritis (RA), 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 PRECISION trial helps to refute the assumption held by many physicians that naproxen treatment results in better cardiovascular outcomes as compared to other NSAIDs, including celecoxib. It is important to note that given the trial’s design – prescription doses and chronic use in patients with cardiovascular risk factors – no inferences are possible regarding the safety of intermittent use of low-dose, over-the-counter NSAIDs.
The results of the PRECISION study were presented at the annual meeting of the American Heart Association in New Orleans by Dr. Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and principal investigator of the PRECISION trial. In addition, the results were published today in the New England Journal of Medicine.
PRECISION was a prospective, long-term non-inferiority trial of 24,081 patients designed to assess the cardiovascular safety of Celebrex (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.
“We are pleased with the results of this landmark study. Questions about the cardiovascular safety of prescription NSAIDs have persisted since the withdrawal of Vioxx (rofecoxib) from the market in 2004,” said Ian Read, chairman and chief executive officer of Pfizer Inc. “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 Celebrex.”
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 (CV) death, non-fatal myocardial infarction (MI) 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 CV risk.
Filed Under: Drug Discovery
