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.

Abstract

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) < or =1.33 and point estimate < or =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.

• Authors: Matthew C Becker, Thomas H Wang, Lisa Wisniewski, Kathy Wolski, Peter Libby, Thomas F Lüscher, Jeffrey S Borer, Alice M Mascette, M Elaine Husni, Daniel H Solomon, David Y Graham, Neville D Yeomans, Henry Krum, Frank Ruschitzka, A Michael Lincoff, Steven E Nissen, PRECISION Investigators
• Journal: American heart journal (Am Heart J) Vol. 157 Issue 4 Pg. 606-12 (Apr 2009) ISSN: 1097-6744 [Electronic] United States
• PMID: 19332185 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Cyclooxygenase Inhibitors
• Pyrazoles
• Sulfonamides
• Naproxen
• Celecoxib
• Ibuprofen

Topics

• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, therapeutic use)
• Arthritis (drug therapy)
• Cardiovascular Diseases (epidemiology, prevention & control)
• Celecoxib
• Cyclooxygenase Inhibitors (administration & dosage, therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Follow-Up Studies
• Humans
• Ibuprofen (administration & dosage, therapeutic use)
• Middle Aged
• Naproxen (administration & dosage, therapeutic use)
• Prospective Studies
• Pyrazoles (administration & dosage, therapeutic use)
• Sulfonamides (administration & dosage, therapeutic use)
• Treatment Outcome