Copyright
©2008 The WJG Press and Baishideng. All rights reserved.
World J Gastroenterol. Jul 28, 2008; 14(28): 4535-4539
Published online Jul 28, 2008. doi: 10.3748/wjg.14.4535
Celecoxib-related gastroduodenal ulcer and cardiovascular events in a randomized trial for gastric cancer prevention
Guo-Shuang Feng, Jun-Ling Ma, Benjamin CY Wong, Lian Zhang, Wei-Dong Liu, Kai-Feng Pan, Lin Shen, Xiao-Dong Zhang, Jie Li, Harry HX Xia, Ji-You Li, Shiu Kum Lam, Wei-Cheng You
Guo-Shuang Feng, Jun-Ling Ma, Lian Zhang, Kai-Feng Pan, Wei-Cheng You, Department of Cancer Epidemiology, Peking University School of Oncology, Beijing Cancer Hospital & Institute, Beijing 100036, China
Benjamin CY Wong, Harry HX Xia, Shiu Kum Lam, Department of Medicine, University of Hong Kong, Hong Kong, China
Lin Shen, Xiao-Dong Zhang, Jie Li, Department of Medical Oncology, Peking University School of Oncology, Beijing Cancer Hospital & Institute, Beijing 100036, China
Ji-You Li, Department of Pathology, Peking University School of Oncology, Beijing Cancer Hospital & Institute, Beijing 100036, China
Wei-Dong Liu, Healthy Bureau of Linqu County, Weifang 262600, Shandong Province, China
Author contributions: Feng GS, Ma JL, Zhang L, Pan KF, and You WC contributed to the concept and designed the study on adverse events of celecoxib use; Ma JL and Liu WD collected the data; Feng GS and Ma JL wrote the manuscript; Feng GS was responsible for the statistical analysis; Shen L, Zhang XD, Li J, and Li JY contributed to the medical supervision in the trial; Xia HHX, Lam SK, and Wong BCY revised the manuscript; You WC supervised the whole study and polished the manuscript.
Correspondence to: Wei-Cheng You, MD, Department of Cancer Epidemiology, Peking University School of Oncology, Beijing Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100036, China. weichengyou@yahoo.com
Telephone: +86-10-88141035
Fax: +86-10-88122437
Received: April 30, 2008
Revised: June 10, 2008
Accepted: June 17, 2008
Published online: July 28, 2008
AIM: 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.
CONCLUSION: Treatment of gastric cancer with celecoxib is not associated with increased risk of gastroduodenal ulcer and cardiovascular events.
