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. 2019 Jan 9;11:561–571. doi: 10.2147/CMAR.S180261

Table 2.

Studies reporting posttreatment effect of celecoxib on incidence of recurrent colorectal adenomas after 2 years of off-treatment

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:

a

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.

b

Study reported that the median time for taking placebo and intervention, respectively, was 13.6 and 14.2 months.

c

Reported efficacy outcomes from follow-up colonoscopy within 5.5 years.

d

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.