Differences in Safety of Nonsteroidal Antiinflammatory Drugs in Patients With Osteoarthritis and Patients With Rheumatoid Arthritis A Randomized Clinical Trial
Daniel H Solomon, M Elaine Husni, Katherine E Wolski, Lisa M Wisniewski, Jeffrey S Borer, David Y Graham, Peter Libby, A Michael Lincoff, Thomas F Luescher, Venu Menon, Neville D Yeomans, Qiuqing Wang, Weihang Bao, Manuela F Berger, Steven E Nissen
ARTHRITIS & RHEUMATOLOGY | WILEY | Published : 2018
OBJECTIVE: To determine the relative risks of cardiovascular (CV), gastrointestinal (GI), and renal adverse events during long-term treatment with celecoxib, compared with ibuprofen and naproxen, in patients with osteoarthritis (OA) and patients with rheumatoid arthritis (RA). METHODS: A total of 24,081 patients with OA or RA who had a moderate or high risk for CV disease were enrolled internationally into a double-blind randomized controlled trial. Interventions included celecoxib at a dosage of 100-200 mg twice daily, ibuprofen at a dosage of 600-800 mg 3 times daily, or naproxen at a dosage of 375-500 mg twice daily. The main outcomes were the first occurrence of a major adverse CV event,..View full abstract
The PRECISION trial and these analyses were funded by Pfizer.Dr. Solomon has received research support from Pfizer and royalties for a peer-reviewed chapter titled NSAIDS: Therapeutic use and variability of response in adults in UpToDate (2017). Dr. Husni has received consulting fees and/or honoraria from AbbVie, Bristol-Myers Squibb, Amgen, UCB, Regeneron, and Janssen (less than0,000 each) and research support from Sanofi Genzyme. Dr. Borer has received consulting fees and/or honoraria from Pfizer (more than 0,000). Dr. Graham has received consulting fees from RedHill Biopharma, BioGaia, and Takeda (less than 0,000 each) research support from RedHill Biopharma. Dr. Libby has received research support from Novartis (less than 0,000). Dr. Lincoff has received consulting fees from Novo Nordisk (more than 0,000). Dr. Luscher has received consulting fees, speaking fees, and/or honoraria from Bayer Health Care (less than 0,000). Dr. Yeomans has received consulting fees and/or honoraria from Pfizer (less than 0,000). Drs. Bao and Berger own stock or stock options in Pfizer..