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

Table 1.

RCTs reporting incidence of recurrent colorectal adenomas

Reference year	Study name	Design	Treatment duration (years)	Follow-up colonoscopy	Subjects	Study group (n originally randomized)	Efficacy outcomes (n/N)		Safety outcomes (n/N)					High CV risk, n (%)^a
Reference year	Study name	Design	Treatment duration (years)	Follow-up colonoscopy	Subjects	Study group (n originally randomized)	Advanced adenomas	Any adenomas	CRC	Mortality (any causes)	Serious adverse events	Renal-hypertensive disorders	Serious CV events^a	High CV risk, n (%)^a
Arber et al, 2006²³	PreSAP	Multicenter, double-blind, placebo-controlled, RCT, parallel two-arm	3	At year 1, year 3, or both	Median age 61; 66% males	Celecoxib 400 mg once daily (n=933)	42/840	270/840	6/933	11/933	186/933	193/933	23/933	575 (37)
Arber et al, 2006²³	PreSAP		3	At year 1, year 3, or both	Median age 61; 66% males	Placebo (n=628)	56/557	264/557	1/628	7/628	106/628	96/628	12/628	575 (37)
Bertagnolli et al, 2006²⁴	APC	Multicenter, double-blind, placebo-controlled, RCT, parallel three-arm	3	At year 1, year 3, or both	Median age 59; 68% males	Celecoxib 200 mg twice daily (n=685)	44/613	252/613	0/685	8/685	139/685	164/685	20/685	962 (47)
						Celecoxib 400 mg twice daily (n=671)	35/601	213/601	4/671	10/671	154/671	141/671	27/671
						Placebo (n=679)	99/608	354/608	3/679	6/679	127/679	130/679	8/679
Thompson et al, 2016⁴¹	Sel/Cel	Multicenter, double-blind, placebo-controlled, RCT, 2×2 factorial	1^b	Within 1 year of discontinuing intervention^c	Mean age 63; 68% males	Celecoxib 400 mg once daily (n=414)	3/119^d	34/123	NA	NA	104/414	55/414	35/414	418 (51)
Thompson et al, 2016⁴¹	Sel/Cel		1^b	Within 1 year of discontinuing intervention^c	Mean age 63; 68% males	Placebo (n=410)	12/119^d	50/121	NA	NA	93/410	43/410	38/410

Notes:

Adjudicated data from Solomon et al.;¹⁹

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

Efficacy outcomes at different time intervals were reported after discontinuing intervention; as per our protocol, we have used data from subjects undergoing colonoscopy within 1 year of discontinuing intervention;

Advanced status uncertain for six participants. n= number of events; N= number of participants.

Abbreviations: APC, Adenoma Prevention with Celecoxib trial; CRC, colorectal cancer; CV, cardiovascular; PreSAP, Prevention of Colorectal Sporadic Adenomatous Polyps Study; RCT, randomized controlled trial; Sel/Cel, Selenium and Celecoxib (Sel/Cel) Trial; NA, not available.