Adenoma Prevention Celecoxib Study

Bagheri D

Bertagnolli MM

Breazna A

Burn J

Chung DC

Collins NT

Dewar T

Eagle CJ

Foley TR

Hawk ET

Hoffman N

Kim K

Macrae F

Pruitt RE

Redston M

Rosenstein RB

Saltzman JR

Salzberg B

Sylwestrowicz T

Tang J

Umar A

Zauber AG

The Adenoma Prevention with Celecoxib Trial examined the efficacy and safety of the cyclooxygenase (Cox)-2 inhibitor, celecoxib, for sporadic colorectal adenoma prevention in patients at high risk for colorectal cancer. The trial randomized 2,035 subjects to receive either placebo, celecoxib 200 mg twice daily, or celecoxib 400 mg twice daily. The primary study safety and efficacy analyses involved 3 years of treatment. The results showed significant antitumor effect but also indicated increased cardiovascular adverse events in patients treated with celecoxib compared with placebo. A total of 933 patients participated in an extension of the Adenoma Prevention with Celecoxib Trial, with a planned total treatment and surveillance duration of 5 years. Study medication was stopped early, resulting in a median treatment duration of 3.1 years for those with a year 5 colonoscopy. Patients treated on the placebo arm had a cumulative adenoma incidence of 68.4% over 5 years of observation. This figure was 59.0% (

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Five-Year Efficacy and Safety Analysis of the Adenoma Prevention with Celecoxib Trial

Five-Year Efficacy and Safety Analysis of the Adenoma Prevention with Celecoxib Trial

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