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.

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