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Title: Effect of Aspirin Coadministration on the Safety of Celecoxib, Naproxen, or Ibuprofen.
Austin Authors: Reed, Grant W;Abdallah, Mouin S;Shao, Mingyuan;Wolski, Kathy;Wisniewski, Lisa;Yeomans, Neville D ;Lüscher, Thomas F;Borer, Jeffrey S;Graham, David Y;Husni, M Elaine;Solomon, Daniel H;Libby, Peter;Menon, Venu;Lincoff, A Michael;Nissen, Steven E
Affiliation: Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio
Department of Medicine, Austin Health, The University of Melbourne, Heidelberg, Victoria, Australia
Western Sydney University, Campbelltown, New South Wales, Australia
Royal Brompton & Harefield Hospitals Trust and Imperial College, London, United Kingdom
Schiavone Cardiovascular Translational Research Institute, State University of New York, Downstate Medical Center and College of Medicine, Brooklyn and New York, New York
Baylor College of Medicine, Veterans Affairs Medical Center, Houston, Texas
Department of Rheumatic and Immunologic Diseases, Cleveland Clinic, Cleveland, Ohio
Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
Issue Date: 24-Apr-2018
Publication information: Journal of the American College of Cardiology 2018; 71(16): 1741-1751
Abstract: The safety of nonsteroidal anti-inflammatory drug (NSAID) and aspirin coadministration is uncertain. The aim of this study was to compare the safety of combining NSAIDs with low-dose aspirin. This analysis of the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen) trial included 23,953 patients with osteoarthritis or rheumatoid arthritis at increased cardiovascular risk randomized to celecoxib, ibuprofen, or naproxen. The on-treatment population was used for this study. Outcomes included composite major adverse cardiovascular events, noncardiovascular death, gastrointestinal or renal events, and components of the composite. Cox proportional hazards models compared outcomes among NSAIDs stratified by aspirin use following propensity score adjustment. Kaplan-Meier analysis was used to compare the cumulative probability of events. When taken without aspirin, naproxen or ibuprofen had greater risk for the primary composite endpoint compared with celecoxib (hazard ratio [HR]: 1.52; 95% confidence interval [CI]: 1.22 to 1.90, p <0.001; and HR: 1.81; 95% CI: 1.46 to 2.26; p <0.001, respectively). Compared with celecoxib, ibuprofen had more major adverse cardiovascular events (p < 0.05), and both ibuprofen and naproxen had more gastrointestinal (p < 0.001) and renal (p < 0.05) events. Taken with aspirin, ibuprofen had greater risk for the primary composite endpoint compared with celecoxib (HR: 1.27; 95% CI: 1.06 to 1.51; p < 0.01); this was not significantly higher with naproxen (HR: 1.18; 95% CI: 0.98 to 1.41; p = 0.08). Among patients on aspirin, major adverse cardiovascular events were similar among NSAIDs, and compared with celecoxib, ibuprofen had more gastrointestinal and renal events (p < 0.05), while naproxen had more gastrointestinal events (p < 0.05), without a difference in renal events. Similar results were seen on adjusted Kaplan-Meier analysis. Celecoxib has a more favorable overall safety profile than naproxen or ibuprofen when taken without aspirin. Adding aspirin attenuates the safety advantage of celecoxib, although celecoxib is still associated with fewer gastrointestinal events than ibuprofen or naproxen and fewer renal events than ibuprofen. (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen or Naproxen [PRECISION]; NCT00346216).
DOI: 10.1016/j.jacc.2018.02.036
ORCID: 0000-0001-9870-832X
Journal: Journal of the American College of Cardiology
PubMed URL: 29673465
Type: Journal Article
Subjects: aspirin
nonsteroidal anti-inflammatory drugs
Appears in Collections:Journal articles

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