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Table 2 Characteristics of RCTs and summary of effects of non-aspirin NSAIDs on the incidence of recurrent colorectal adenomas

From: Effects of aspirin and non-aspirin nonsteroidal anti-inflammatory drugs on the incidence of recurrent colorectal adenomas: a systematic review with meta-analysis and trial sequential analysis of randomized clinical trials

Study, year, (study name) Location Duration of treatment (follow-up schedule) Population Interventions (Number of patients randomized, n) Outcomes % of randomized participants excluded from main analyses Compliance to treatments Reported Results
Arber 2006
(The Prevention of Colorectal Sporadic Adenomatous Polyps (Pre SAP) study) [37]
Multi-national ≈3 years (1 and 3 years after the baseline examination) Age – median, 61 years; range, 30–92 years; % male: 66; subjects with history of adenomas; and documented clean colon post-polypectomy. Celecoxib 400 mg/day (n = 933); placebo (n = 628) Primary outcome: adenoma recurrence at year 1, 3, or both
Secondary outcomes: advanced adenomas recurrence at year 1, 3, or both; cardiovascular outcomes and adverse events (advanced adenoma defined as adenoma ≥1.0 cm (villous or tubule-villous histology); high-grade dysplasia; Intra-mucosal carcinoma or invasive cancer)
11% excluded from analysis as no follow-up colonoscopy at year 1 or year 3 78% of participants reported taking the majority of their study medications, with similar compliance between arms Relative Risk (95% CI)
Celecoxib 400 mg versus placebo
Any adenoma: 0.64 (0.56–0.75)
Advanced adenoma: 0.49 (0.33–0.73)
Bertagnolli 2006 (The Adenoma Prevention with Celecoxib (APC) trial) [38] Multi-national 3 years (1 and 3 years after the baseline examination) Age – median, 59 years; range, 31–88 years; % male: 68; subjects with history of adenomas; and documented clean colon post-polypectomy. Celecoxib 400 mg/day (n = 685);
Celecoxib 800 mg/day (n = 671);
Placebo (n = 679)
Primary outcome: adenoma recurrence at year 1, 3, or both
Secondary outcomes: advanced adenomas recurrence at year 1, 3, or both; number of adenomas; size of largest adenoma; adenoma burden; cardiovascular outcomes and adverse events (advanced adenoma defined as adenoma ≥1.0 cm (villous or tubule-villous histology); high-grade dysplasia; Intra-mucosal carcinoma or invasive cancer)
10% excluded from analysis as no follow-up colonoscopy at year 1 or year 3 ≈ 68% of participants reported taking the majority of their study medications at least 80% of the time, with similar compliance between arms. Relative Risk (95% CI)
Celecoxib 400 versus placebo
Any adenoma: 0.67 (0.59–0.77)
Advanced adenoma: 0.43 (0.31–0.61)
Celecoxib 800 versus placebo
Any adenoma: 0.55 (0.48–0.64)
Advanced adenoma: 0.34 (0.24–0.50)
Summary for celecoxib, 400 mg/day versus placebo
Relative Risk (95% CI)
Any adenoma: 0.66 (0.59–0.72)
Advanced adenoma: 0.45 (0.33–0.57)
Baron 2006
(The Adenomatous Polyp PRevention On Vioxx (APPROVe) Trial [28]
Multi-national 3 years (1 and 3 years after the baseline examination) Age – mean, 59.4 years; range, 40–86 years; % male: 62.3%; subjects with history of adenomas; and documented clean colon post-polypectomy. Rofecoxib 25 mg/day (n = 1277); placebo(n = 1293) Primary outcome: ≥1 adenoma at year 1 or 3 on colonoscopy
Secondary outcomes: number of adenomas; advanced adenomas; death; cardiovascular and gastrointestinal events (advanced adenoma defined as adenoma ≥1.0 cm (villous or tubule-villous histology); high-grade dysplasia; Intra-mucosal carcinoma or invasive cancer)
7% excluded from analysis as no follow-up colonoscopy More than 87% of subjects reported taking at least 90% of their tablets in the third year of the trial Relative Risk (95% CI)
Rofecoxib versus placebo
Any adenoma: 0.76 (0.69–0.83)
Advanced adenoma: 0.56 (0.42–0.75)