Rationale, design, and governance of Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen Or Naproxen (PRECISION), a cardiovascular end point trial of nonsteroidal antiinflammatory agents in patients with arthritis

• Published in: The American heart journal Vol. 157; no. 4; pp. 606 - 612
• Main Authors: Becker, Matthew C., MD, Wang, Thomas H., MD, Wisniewski, Lisa, RN, Wolski, Kathy, MPH, Libby, Peter, MD, Lüscher, Thomas F., MD, Borer, Jeffrey S., MD, Mascette, Alice M., MD, Husni, M. Elaine, MD, MPH, Solomon, Daniel H., MD, MPH, Graham, David Y., MD, Yeomans, Neville D., MD, Krum, Henry, MBBS, PhD, FRACP, Ruschitzka, Frank, MD, Lincoff, A. Michael, MD, Nissen, Steven E., MD
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.04.2009; Mosby; Elsevier Limited
• Subjects: Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Arthritis; Arthritis - drug therapy; Aspirin; Biological and medical sciences; Blood platelets; Blood pressure; Bones, joints and connective tissue. Antiinflammatory agents; Cardiology. Vascular system; Cardiovascular; Cardiovascular Diseases - epidemiology; Cardiovascular Diseases - prevention & control; Celecoxib; Cyclooxygenase Inhibitors - administration & dosage; Cyclooxygenase Inhibitors - therapeutic use; Diseases of the osteoarticular system; Dose-Response Relationship, Drug; Double-Blind Method; Drug dosages; Drug therapy; Follow-Up Studies; Heart attacks; Heart failure; Humans; Hypertension; Ibuprofen - administration & dosage; Ibuprofen - therapeutic use; Medical sciences; Meetings; Middle Aged; Miscellaneous. Osteoarticular involvement in other diseases; Naproxen - administration & dosage; Naproxen - therapeutic use; Patients; Pharmacology. Drug treatments; Prospective Studies; Pyrazoles - administration & dosage; Pyrazoles - therapeutic use; Quality of life; Stroke; Studies; Sulfonamides - administration & dosage; Sulfonamides - therapeutic use; Treatment Outcome; Human; Evaluation; Toxicity; Diseases of the osteoarticular system; Cardiovascular disease; Arthritis; Celecoxib; Non steroidal antiinflammatory agent; Design; Prospective; Randomization; Naproxen; Ibuprofen; Complication; End; Circulatory system; Safety; Cardiology; Comparative study
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2008.12.014

Background Pain management in patients with osteoarthritis or rheumatoid arthritis often requires long-term use of nonsteroidal antiinflammatory drugs (NSAIDs). However, the relative cardiovascular safety of these therapies remains uncertain. Methods The Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen Or Naproxen (PRECISION) trial will evaluate the cardiovascular safety of celecoxib, ibuprofen, and naproxen. Approximately 20,000 patients with symptomatic osteoarthritis or rheumatoid arthritis at high risk for, or with, established cardiovascular disease will be randomized in this double-blind, triple dummy, multinational, multicenter study. The primary end point is the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. The trial will continue until 762 primary events occur with at least 18 months follow-up. Noninferiority of any of the regimens will require a 97.5% upper CI of the hazard ratio (HR) ≤1.33 and point estimate ≤1.12 for both intent-to-treat (ITT) and modified ITT populations. Conclusion PRECISION, the first study of patients with high cardiovascular risk chronically treated with a cyclooxygenase-2 selective inhibitor or nonselective NSAID, will define the relative cardiovascular safety profile of celecoxib, ibuprofen, and naproxen and provide data to help guide NSAID use for pain management for this population.