Celecoxib-related gastroduodenal ulcer and cardiovascular events in a randomized trial for gastric cancer prevention.
OBJECTIVE
To evaluate the long-term risk of gastroduodenal ulcer and cardiovascular events induced by celecoxib in a population-based, randomized, double-blind, placebo-controlled study.


METHODS
From 2004 to 2006, a total of 1024 Chinese patients (aged 35 to 64 years) with severe chronic atrophic gastritis, intestinal metaplasia or dysplasia were randomly assigned to receive 200 mg of celecoxib twice daily or placebo in Linqu County (Shandong Province, China), a high-risk area of gastric cancer. All gastroduodenal ulcer and cardiovascular events occurred were recorded and the patients were followed up for 1.5 years after treatment. At the end of the trial, a systematic interview survey about other adverse events was conducted.


RESULTS
Gastroduodenal ulcer was detected in 19 of 463 (3.72%) patients who received celecoxib and 17 of 473 (3.31%) patients who received placebo, respectively (odds ratio = 1.13, 95% CI = 0.58-2.19). Cardiovascular (CV) events occurred in 4 patients who received celecoxib and in 5 patients who received placebo, respectively. Compared with those who received placebo, patients who received celecoxib had no significant increase in occurrence of CV events (hazard ratio = 0.84, 95% CI = 0.23-3.15). Among the adverse events acquired by interview survey, only the frequency of bloating was significantly higher in patients treated with celecoxib than in those treated with placebo.


CONCLUSIONS
Treatment of gastric cancer with celecoxib is not associated with increased risk of gastroduodenal ulcer and cardiovascular events.
Feng
Guo-Shuang
GS
Department of Cancer Epidemiology, Peking University School of Oncology, Beijing 100036, China.
Ma
Jun-Ling
JL
Wong
Benjamin C Y
BC
Zhang
Lian
L
Liu
Wei-Dong
WD
Pan
Kai-Feng
KF
Shen
Lin
L
Zhang
Xiao-Dong
XD
Li
Jie
J
Xia
Harry Hx
HH
Li
Ji-You
JY
Lam
Shiu Kum
SK
You
Wei-Cheng
WC
D000328:Adult; D002318:Cardiovascular Diseases / Q000139:chemically induced*; D000068579:Celecoxib; D002681:China; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000139:chemically induced; D010437:Peptic Ulcer / Q000139:chemically induced*; D011720:Pyrazoles / Q000009:adverse effects* / Q000627:therapeutic use*; D012307:Risk Factors; D013274:Stomach Neoplasms / Q000517:prevention & control*; D020521:Stroke / Q000139:chemically induced; D013449:Sulfonamides / Q000009:adverse effects* / Q000627:therapeutic use*
D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib