Five-Year Analysis of the Prevention of Colorectal Sporadic Adenomatous Polyps Trial

• DOI: 10.1038/ajg.2011.116
• Publication Date: 2011-04-19T12:00:41Z
• Authors: Nadir Arber; Julius Spicak; István Rácz; Miroslav Zavoral; Aurora Breazna; Paola Gerletti; Maria J Lechuga; Neal Collins; Rebecca B Rosenstein; Craig J Eagle; Bernard Levin
• Keywords: Celecoxib; Colorectal adenoma

OBJECTIVES: Subjects in the Prevention of Colorectal Sporadic Adenomatous Polyps (PreSAP) trial (PRESAP/NCT00141193/www.clinicaltrials.gov) were studied to determine efficacy and safety at a year 5 assessment. METHODS: In this randomized, placebo-controlled, double-blind trial, 1,561 subjects with diagnosed colorectal adenomas removed within 3 months study's initiation assessed after ∼3 years on celecoxib followed by 2 off. Studied 107 primary secondary care settings, stratified cardioprotective aspirin use randomized receive orally 400 mg (933 subjects) or placebo (628 once daily. Efficacy was measured colonoscopy 1, 3, 5, investigators for on-treatment period collected subject self-report over post-treatment. RESULTS: At outcome measure rate new cumulatively from baseline. This statistically significantly lower group (51.4%) than (57.5%;P<0.001). Similarly, cumulative advanced (10.0%) (13.8%;P=0.007). However, interval measure, which not did take rates previous into account, showed that off treatment, (27.0%) 1.66 times more likely have (16.3%;P<0.0001). percentage patients higher (5.0%) (3.8%) (P=0.0072). The evaluation baseline through indicated risks serious cardiac disorders (relative risk (RR) 1.66; 95% confidence (CI) 1.01–2.73), selected renal/hypertension events (RR 1.35; CI 1.09–1.68), general vascular 1.34; 1.08–1.68) 1.59; 1.12–2.26) those taking placebo. CONCLUSIONS: measures incidence group, but these perhaps suggesting release cyclooxygenase-2 inhibition. Consistent what has been previously reported, increased associated therapy mandates caution patient selection.