Objectives:

To evaluate the risk of major upper gastrointestinal bleeding (UGIB) in relation to the use of drugs, in particular nonnarcotic analgesics and NSAIDs.

To quantify associations between individual analgesics and NSAIDs and UGIB.

To quantify associations between other factors and UGIB, where numbers permit.

Methods:

For this case-control study, newly diagnosed cases of UGIB were identified from 25 hospitals in Eastern Massachusetts, 18 hospitals in the region of Stockholm , Sweden , and 12 hospitals in Budapest , Hungary . For each case, 2-3 neighbor ( U.S. and Sweden ) or hospital ( Hungary ) controls of the same age and sex as the cases were enrolled; the community controls were identified from census lists. Cases and controls were interviewed at home by telephone (U.S. and Sweden) or in person in the hospital (Hungary) to obtain information on recent analgesic and other drug use (including the duration, frequency, and for analgesics, dose of each episode), personal data and habits (e.g., marital status, cigarette smoking, alcohol consumption), and relevant medical history. For the cases, information on the symptoms and clinical course of their illness were also obtained, along with a copy of their hospital discharge summary. There were 1450 cases of UGIB and 3400 controls included in the study.

Results:

Key published findings include associations with various NSAIDs; a dose-response relation of UGIB with alcohol consumption; a similar risk due to enteric coated and buffered aspirin compared with regular aspirin; and a lack of association with calcium channel blockers. The combined effects of NSAIDS and alcohol have also been documented, and the clinical characteristics of UGIB have been described.

Investigators:

David Kaufman, Sc.D., Principal Investigator
Judith Kelly, M.S., Co-Investigator
Bengt-Erik Wiholm, M.D., Co-Investigator
Laszlo Andras, M.D., Co-Investigator

Source of funding:

National Institute of Diabetes and Digestive and Kidney Diseases Multiple pharmaceutical companies
National Corporation of Swedish Pharmacies

Study Period:

January 1987 - June 1996 (data collection)

Publications:

Link to Publications