A randomized trial of rofecoxib for the chemoprevention of colorectal adenomas

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A randomized trial of rofecoxib for the chemoprevention of colorectal adenomas. / Baron, JA; Sandler, RS; Bresalier, RS; Quan, H; Riddell, R; Lanas, A; Bolognese, JA; Oxenius, B; Horgan, K; Loftus, S; Morton, Dion.

In: Gastroenterology, Vol. 131, No. 6, 01.12.2006, p. 1674-1682.

Research output: Contribution to journalArticle

Harvard

Baron, JA, Sandler, RS, Bresalier, RS, Quan, H, Riddell, R, Lanas, A, Bolognese, JA, Oxenius, B, Horgan, K, Loftus, S & Morton, D 2006, 'A randomized trial of rofecoxib for the chemoprevention of colorectal adenomas', Gastroenterology, vol. 131, no. 6, pp. 1674-1682. https://doi.org/10.1053/j.gastro.2006.08.079

APA

Baron, JA., Sandler, RS., Bresalier, RS., Quan, H., Riddell, R., Lanas, A., Bolognese, JA., Oxenius, B., Horgan, K., Loftus, S., & Morton, D. (2006). A randomized trial of rofecoxib for the chemoprevention of colorectal adenomas. Gastroenterology, 131(6), 1674-1682. https://doi.org/10.1053/j.gastro.2006.08.079

Vancouver

Baron JA, Sandler RS, Bresalier RS, Quan H, Riddell R, Lanas A et al. A randomized trial of rofecoxib for the chemoprevention of colorectal adenomas. Gastroenterology. 2006 Dec 1;131(6):1674-1682. https://doi.org/10.1053/j.gastro.2006.08.079

Author

Baron, JA ; Sandler, RS ; Bresalier, RS ; Quan, H ; Riddell, R ; Lanas, A ; Bolognese, JA ; Oxenius, B ; Horgan, K ; Loftus, S ; Morton, Dion. / A randomized trial of rofecoxib for the chemoprevention of colorectal adenomas. In: Gastroenterology. 2006 ; Vol. 131, No. 6. pp. 1674-1682.

Bibtex

@article{494d64c8f78842d794a5663882681a65,
title = "A randomized trial of rofecoxib for the chemoprevention of colorectal adenomas",
abstract = "BACKGROUND & AIMS: In human and animal studies, nonsteroidal anti-inflammatory drugs have been associated with a reduced risk of colorectal neoplasia. Although the underlying mechanisms are unknown, inhibition of cyclooxygenase (COX), particularly COX-2, is thought to play a role. We conducted a randomized, placebo-controlled, double-blind trial to assess whether use of the selective COX-2 inhibitor rofecoxib would reduce the risk of colorectal adenomas. METHODS: We randomized 2587 subjects with a recent history of histologically confirmed adenomas to receive daily placebo or 25 mg rofecoxib. Randomization was stratified by baseline use of cardioprotective aspirin. Colonoscopic follow-up evaluation was planned for 1 and 3 years after randomization. The primary end point was all adenomas diagnosed during 3 years' treatment. In a modified intent-to-treat analysis, we computed the relative risk of any adenoma after randomization, using Mantel-Haenszel statistics stratified by low-dose aspirin use at baseline. RESULTS: Adenoma recurrence was less frequent for rofecoxib subjects than for those randomized to placebo (41% vs 55%; P <.0001; relative risk [RR], 0.76; 95% confidence interval [CI], 0.69-0.83). Rofecoxib also conferred a reduction in risk of advanced adenomas (P <.01). The chemopreventive effect was more pronounced in the first year (RR, 0.65; 95% CI, 0.57-0.73) than in the subsequent 2 years (RR, 0.81; 95% CI, 0.71-0.93). As reported previously, rofecoxib was associated with increased risks of significant upper gastrointestinal events and serious thrombotic cardiovascular events. CONCLUSIONS: In this randomized trial, rofecoxib significantly reduced the risk of colorectal adenomas, but also had serious toxicity.",
author = "JA Baron and RS Sandler and RS Bresalier and H Quan and R Riddell and A Lanas and JA Bolognese and B Oxenius and K Horgan and S Loftus and Dion Morton",
year = "2006",
month = dec,
day = "1",
doi = "10.1053/j.gastro.2006.08.079",
language = "English",
volume = "131",
pages = "1674--1682",
journal = "Gastroenterology",
issn = "0016-5085",
publisher = "Elsevier",
number = "6",

}

RIS

TY - JOUR

T1 - A randomized trial of rofecoxib for the chemoprevention of colorectal adenomas

AU - Baron, JA

AU - Sandler, RS

AU - Bresalier, RS

AU - Quan, H

AU - Riddell, R

AU - Lanas, A

AU - Bolognese, JA

AU - Oxenius, B

AU - Horgan, K

AU - Loftus, S

AU - Morton, Dion

PY - 2006/12/1

Y1 - 2006/12/1

N2 - BACKGROUND & AIMS: In human and animal studies, nonsteroidal anti-inflammatory drugs have been associated with a reduced risk of colorectal neoplasia. Although the underlying mechanisms are unknown, inhibition of cyclooxygenase (COX), particularly COX-2, is thought to play a role. We conducted a randomized, placebo-controlled, double-blind trial to assess whether use of the selective COX-2 inhibitor rofecoxib would reduce the risk of colorectal adenomas. METHODS: We randomized 2587 subjects with a recent history of histologically confirmed adenomas to receive daily placebo or 25 mg rofecoxib. Randomization was stratified by baseline use of cardioprotective aspirin. Colonoscopic follow-up evaluation was planned for 1 and 3 years after randomization. The primary end point was all adenomas diagnosed during 3 years' treatment. In a modified intent-to-treat analysis, we computed the relative risk of any adenoma after randomization, using Mantel-Haenszel statistics stratified by low-dose aspirin use at baseline. RESULTS: Adenoma recurrence was less frequent for rofecoxib subjects than for those randomized to placebo (41% vs 55%; P <.0001; relative risk [RR], 0.76; 95% confidence interval [CI], 0.69-0.83). Rofecoxib also conferred a reduction in risk of advanced adenomas (P <.01). The chemopreventive effect was more pronounced in the first year (RR, 0.65; 95% CI, 0.57-0.73) than in the subsequent 2 years (RR, 0.81; 95% CI, 0.71-0.93). As reported previously, rofecoxib was associated with increased risks of significant upper gastrointestinal events and serious thrombotic cardiovascular events. CONCLUSIONS: In this randomized trial, rofecoxib significantly reduced the risk of colorectal adenomas, but also had serious toxicity.

AB - BACKGROUND & AIMS: In human and animal studies, nonsteroidal anti-inflammatory drugs have been associated with a reduced risk of colorectal neoplasia. Although the underlying mechanisms are unknown, inhibition of cyclooxygenase (COX), particularly COX-2, is thought to play a role. We conducted a randomized, placebo-controlled, double-blind trial to assess whether use of the selective COX-2 inhibitor rofecoxib would reduce the risk of colorectal adenomas. METHODS: We randomized 2587 subjects with a recent history of histologically confirmed adenomas to receive daily placebo or 25 mg rofecoxib. Randomization was stratified by baseline use of cardioprotective aspirin. Colonoscopic follow-up evaluation was planned for 1 and 3 years after randomization. The primary end point was all adenomas diagnosed during 3 years' treatment. In a modified intent-to-treat analysis, we computed the relative risk of any adenoma after randomization, using Mantel-Haenszel statistics stratified by low-dose aspirin use at baseline. RESULTS: Adenoma recurrence was less frequent for rofecoxib subjects than for those randomized to placebo (41% vs 55%; P <.0001; relative risk [RR], 0.76; 95% confidence interval [CI], 0.69-0.83). Rofecoxib also conferred a reduction in risk of advanced adenomas (P <.01). The chemopreventive effect was more pronounced in the first year (RR, 0.65; 95% CI, 0.57-0.73) than in the subsequent 2 years (RR, 0.81; 95% CI, 0.71-0.93). As reported previously, rofecoxib was associated with increased risks of significant upper gastrointestinal events and serious thrombotic cardiovascular events. CONCLUSIONS: In this randomized trial, rofecoxib significantly reduced the risk of colorectal adenomas, but also had serious toxicity.

U2 - 10.1053/j.gastro.2006.08.079

DO - 10.1053/j.gastro.2006.08.079

M3 - Article

C2 - 17087947

VL - 131

SP - 1674

EP - 1682

JO - Gastroenterology

JF - Gastroenterology

SN - 0016-5085

IS - 6

ER -