Table 2.
Reference, year | Study name | Design | Subjects | Treatment duration (years) | Follow-up colonoscopy | Duration of off-treatment (years) | Study group (N, originally randomized) | Subjects completed follow-up colonoscopy, n | Efficacy outcomesa (n/N) | |
---|---|---|---|---|---|---|---|---|---|---|
Any adenomas | Advanced adenomas | |||||||||
Arber et al, 201130 | 5-year analysis of PreSAP | Follow-up of double-blind, placebo-controlled RCT; multicenter; parallel two-arm | Mean age 60; 66% males | 3 | 5 | 2 | Celecoxib 400 mg/day (n=933) | 508 | 186/508 | NA |
Placebo (n=628) | 347 | 86/347 | NA | |||||||
Bertagnolli et al, 200931 | 5-year analysis of APC | Follow-up of double-blind, placebo-controlled RCT; multicenter; parallel three-arm | Median age 59; 71% males | 3 | 5 | 2 | Celecoxib 400 mg/day (n=685) | 207 | 83/207 | 13/207 |
Celecoxib 800 mg/day (n=671) | 218 | 90/218 | 22/219 | |||||||
Placebo (n=679) | 214 | 79/214 | 11/214 | |||||||
Thompson et al, 201641 | Sel/Cel | Follow-up of double-blind, placebo-controlled RCT; multicenter; 2×2 factorial | Median age 59; 71% males | 1b | 5.5c | ~4 | Celecoxib 400 mg/day (n=414) | 329 | 124/329 | 28/319d |
Placebo (n=410) | 336 | 135/336 | 32/332d |
Notes:
Arber et al, 201130 – efficacy outcomes from 855 subjects who had colonoscopy at year 5, even if they had one or more new adenomas detected at any time after baseline; Bertagnolli et al, 200931 – efficacy outcomes from 639 subjects in the extension study with any adenoma detected at the year 5 colonoscopy; Thompson et al, 201641 – efficacy outcomes from 447 subjects with a follow-up colonoscopy within 3.5 years of qualifying colonoscopy.
Study reported that the median time for taking placebo and intervention, respectively, was 13.6 and 14.2 months.
Reported efficacy outcomes from follow-up colonoscopy within 5.5 years.
Number of advanced adenomas uncertain for some participants.
Abbreviations: APC, Adenoma Prevention with Celecoxib trial; PreSAP, Prevention of Colorectal Sporadic Adenomatous Polyps Study; RCTs, randomized controlled trials; Sel/Cel, Selenium and Celecoxib (Sel/Cel) Trial; NA, not available.