Effect of Aspirin Coadministration on the Safety of Celecoxib, Naproxen, or Ibuprofen
Grant W Reed, Mouin S Abdallah, Mingyuan Shao, Kathy Wolski, Lisa Wisniewski, Neville Yeomans, Thomas F Luscher, Jeffrey S Borer, David Y Graham, M Elaine Husni, Daniel H Solomon, Peter Libby, Venu Menon, A Michael Lincoff, Steven E Nissen
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | ELSEVIER SCIENCE INC | Published : 2018
BACKGROUND: The safety of nonsteroidal anti-inflammatory drug (NSAID) and aspirin coadministration is uncertain. OBJECTIVES: The aim of this study was to compare the safety of combining NSAIDs with low-dose aspirin. METHODS: 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..View full abstract
This study was funded by Pfizer. Mr. Shao has received grant support from Pfizer to the institution for the PRECISION trial. Ms. Wolski has received grant support from Pfizer to the institution for the PRECISION trial. Ms. Wisniewski has received grant support from Pfizer to the institution for the PRECISION trial. Dr. Yeomans has received payment for membership on a Pfizer advisory board. Dr. Luscher has received grant support to the institution from Abbott, AstraZeneca, Bayer Health Care, Biotronik, Boston Scientific, Eli Lilly, Medtronic, Novartis, Servier, and St. Jude; and personal fees from Bayer Health Care for membership on the adjudication committee in the ARIVE trial. Dr. Borer served as chair of a data and safety monitoring board for an unrelated product being developed by Pfizer; has served as a consultant, trial executive committee member, data and safety monitoring board member, or cardiac event adjudication committee member for unrelated products for Amgen, Novartis, AstraZeneca, Takeda, Biotronik, Servier, GlaxoSmithKline, Gilead, and ARMGO; and owns stock in BioMarin and ARMGO. Dr. Graham is a consultant for RedHill Biopharma regarding novel Helicobacter pylori therapies; has received research support from RedHill Biopharma for culture of H. pylori; is the principal investigator of an international study of the use of antimycobacterial therapy for Crohn's disease; and is a consultant for BioGaia in relation to probiotic therapy for H. pylori infection and for Takeda in relation to H. pylori therapies. Dr. Husni has received an institution grant to perform the PRECISION trial; has received a Sanofi Genzyme investigator grant; and has served on advisory boards for AbbVie, Bristol-Myers Squibb, Amgen, UCB, Regeneron, and Janssen. Dr. Solomon has received a research grant from Pfizer for unrelated work; and has received royalties from UpToDate for a chapter about NSAIDs. Dr. Libby has been an unpaid consultant to or has been involved in clinical trials for Amgen, AstraZeneca, Esperion Therapeutics, Ionis Pharmaceuticals, Kowa Pharmaceuticals, Merck, Novartis, Pfizer, Sanofi-Regeneron, Takeda Pharmaceuticals, and XBiotech; has served as a member of scientific advisory boards for Amgen, Corvidia Therapeutics, DalCor Pharmaceuticals, Kowa Pharmaceuticals, Olatec Therapeutics, Medimmune, and Novartis; and his laboratory has received research funding in the past 2 years from Novartis. Dr. Menon has received grant support to the institution to perform the PRECISION trial. Dr. Lincoff has received grant support to the institution to perform the PRECISION trial; is a consultant for Amgen, Novo, Nordisk, Sanofi, Abbott, Sarpeta, and Sermonix; and has received research grants to his institution from Pfizer, AstraZeneca, Esperion, AbbVie, Eli Lilly, and Roche. Dr. Nissen has received grant support to the institution to perform the PRECISION trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.