Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen

Summary

To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.

Timeline

Start

2006-10-04

Primary completion

2016-04-12

Completion

2016-04-12

Publications

• Agarwal N, St John J, Sunder V, Sarraju A, Laffin LJ. Association of Systolic Blood Pressure Time in Target Range With Cardiovascular Events Among PRECISION Participants. J Clin Hypertens (Greenwich). 2025 Jul;27(7):e70009. doi: 10.1111/jch.70009.
• Obeid S, Libby P, Husni E, Wang Q, Wisniewski LM, Davey DA, Wolski KE, Xia F, Bao W, Walker C, Ruschitzka F, Nissen SE, Luscher TF. Cardiorenal risk of celecoxib compared with naproxen or ibuprofen in arthritis patients: insights from the PRECISION trial. Eur Heart J Cardiovasc Pharmacother. 2022 Sep 3;8(6):611-621. doi: 10.1093/ehjcvp/pvac015.
• Chirikov VV, Walker C, Stephens JM, Schepman P, Chambers R, Bakir M, Poorman GW, Haider S, Farghaly M. Evaluating the Cost-Effectiveness of Celecoxib versus Ibuprofen and Naproxen in Patients with Osteoarthritis in United Arab Emirates Based on the PRECISION Trial. Clinicoecon Outcomes Res. 2021 May 19;13:409-420. doi: 10.2147/CEOR.S280556. eCollection 2021.
• Bao W, Gaffney M, Pressler ML, Fayyad R, Wisemandle W, Beckerman B, Wolski KE, Nissen SE. Strengthening the interpretability of clinical trial results by assessing the effect of informative censoring on the primary estimand in PRECISION. Clin Trials. 2020 Oct;17(5):535-544. doi: 10.1177/1740774520934747. Epub 2020 Jul 9.
• Solomon DH, Shao M, Wolski K, Nissen S, Husni ME, Paynter N. Derivation and Validation of a Major Toxicity Risk Score Among Nonsteroidal Antiinflammatory Drug Users Based on Data From a Randomized Controlled Trial. Arthritis Rheumatol. 2019 Aug;71(8):1225-1231. doi: 10.1002/art.40870. Epub 2019 Jun 12.
• Reed GW, Abdallah MS, Shao M, Wolski K, Wisniewski L, Yeomans N, Luscher TF, Borer JS, Graham DY, Husni ME, Solomon DH, Libby P, Menon V, Lincoff AM, Nissen SE. Effect of Aspirin Coadministration on the Safety of Celecoxib, Naproxen, or Ibuprofen. J Am Coll Cardiol. 2018 Apr 24;71(16):1741-1751. doi: 10.1016/j.jacc.2018.02.036.
• Solomon DH, Husni ME, Wolski KE, Wisniewski LM, Borer JS, Graham DY, Libby P, Lincoff AM, Luscher TF, Menon V, Yeomans ND, Wang Q, Bao W, Berger MF, Nissen SE; PRECISION Trial Investigators. Differences in Safety of Nonsteroidal Antiinflammatory Drugs in Patients With Osteoarthritis and Patients With Rheumatoid Arthritis: A Randomized Clinical Trial. Arthritis Rheumatol. 2018 Apr;70(4):537-546. doi: 10.1002/art.40400.
• Ruschitzka F, Borer JS, Krum H, Flammer AJ, Yeomans ND, Libby P, Luscher TF, Solomon DH, Husni ME, Graham DY, Davey DA, Wisniewski LM, Menon V, Fayyad R, Beckerman B, Iorga D, Lincoff AM, Nissen SE. Differential blood pressure effects of ibuprofen, naproxen, and celecoxib in patients with arthritis: the PRECISION-ABPM (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen Ambulatory Blood Pressure Measurement) Trial. Eur Heart J. 2017 Nov 21;38(44):3282-3292. doi: 10.1093/eurheartj/ehx508.
• Nissen SE, Yeomans ND, Solomon DH, Luscher TF, Libby P, Husni ME, Graham DY, Borer JS, Wisniewski LM, Wolski KE, Wang Q, Menon V, Ruschitzka F, Gaffney M, Beckerman B, Berger MF, Bao W, Lincoff AM; PRECISION Trial Investigators. Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. N Engl J Med. 2016 Dec 29;375(26):2519-29. doi: 10.1056/NEJMoa1611593. Epub 2016 Nov 13.

Drugs

Indications