Cardiovascular (CV) Safety of Celecoxib for Chronic Use
Results from the landmark PRECISION trials indicate that CV, GI and renal risks associated with long term use of Celecoxib is low and it is safer than other NSAIDs such as Naproxen and Ibuprofen in patients with CV risk. Clinical trial results were presented at the Scientific Sessions of the American Heart Association, November 12-16, 2016 in New Orleans, LA.
"After the withdrawal of rofecoxib, there ensued a rush to judgement about the cardiovascular safety of Cox-2 inhibitors. Fueled by the controversy and some experts commentary used observational data, small RCTs and theoretical concerns to 'confirm' what they expected. The PRECISION trial demonstrates the hazards inherent in prejudgment about the risks and benefits of therapies based upon expectations and indirect methods. These findings serve as an important warning to the medical community that we may arrive at erroneous conclusion when we fail to follow a systematic and unbiased approach to scientific and public health questions".
Steven Nissen, MD
Principal Investigator, PRECISION Trial
Chairman, Cardiovascular Medicine
The Cleveland Clinic Foundation
November 13, 2016 AHA's Scientific Sessions, New Orleans, LA
April 25, 2018: The FDA's Arthritis Advisory Committee (AAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) voted by a large margin (15:5) that the CV safety of Celecoxib is comparable to Naproxen and Ibuprofen.
PRECISION Trial Research Paper