Case-Control Study on the Association of Upper GI Bleeding and Nonsteroidal Anti-inflammatory Drugs in Japan

Objectives

This case-control study was designed to estimate the association between upper gastrointestinal bleeding (UGIB) and the use of prescription and OTC NSAIDs, including aspirin in Japan. It will also estimate the association between UGIB and other risk factors, such as age, gender, history of GI ulcer, Helicobacter pylori infection, smoking, and alcohol in Japan.

Methods

A total of 175 UGIB cases were enrolled from 14 hospitals; 347 age and sex-matched controls were identified from registries in the same district as the cases resided. Information on demographics, use of analgesics and NSAIDs, and other risk factors for UGIB was obtained by telephone interview. H. pylori status was ascertained from a urine test in all cases and 225 controls. The Slone Epidemiology Center acted in an advisory capacity based on our previous experience conducting an international multicenter study of UGIB.

Results

A positive association was documented for aspirin (odds ratio, 5.5), non-aspirin NSAIDS (6.1), and H. pylori infection (4.9). The findings demonstrate that these factors behave similarly in the Japanese population as in other parts of the world. Other analyses are in progress.

Investigators and Study Staff

Investigators:

Kiyoshi Kubota, M.D., Principal Investigator
University of Tokyo

Tsugumichi Sato, Ph.D.
Drug Safety Research Unit Japan

Susana Perez-Gutthann, M.D., Ph.D.
Global Epidemiology and Drug Safety
Pfizer, Inc.

David W. Kaufman, Sc.D., Associate Director
Slone Epidemiology Center

Steering Committee:

Akira Terano, M.D., Professor
Dokkyo University School of Medicine
Chairman

Kentaro Sugano, M.D., Professor
Jichi Medical School

Shinichi Ota, M.D., Professor
Saitama Medical School

Kiyoshi Kubota, M.D.
Faculty of Medicine
University of Tokyo

Choitsu Sakamoto, M.D., Professor
Nippon Medical School

David W. Kaufman, Sc.D.
Associate Director
Slone Epidemiology Center

Study Adviser:

Jane E. Sheehan, R.N., M.S.

Study Details

Source of Funding:

Pfizer, Inc.

Study Period:

June 2002 to June 2005

Publications

Sakamoto C, Sugano K, Ota S, Sakaki N, Takahashi S, Yoshida Y, Tsukui T, Osawa H, Sakurai Y, Yoshino J, Mizokami Y, Mine T, Arakawa T, Kuwayama H, Saigenji K, Yakabi K, Chiba T, Shimosegawa T, Sheehan JE, Perez-Gutthann S, Yamaguchi T, Kaufman DW, Sato T, Kubota K, Terano A.  Case-control study on the association of upper gastrointestinal bleeding and nonsteroidal anti-inflammatory drugs in Japan.  Eur J Clin Pharmacol 2006;62:765-72.