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July 10, 1995

Peptic Ulcer and Gastrointestinal Hemorrhage Associated With Nonsteroidal Anti-inflammatory Drug Use in Patients Younger Than 65 Years: A Large Health Maintenance Organization Cohort Study

Author Affiliations

From Epidemiology Resources Inc, Newton Lower Falls, Mass (Ms Lanza and Drs Walker and Dreyer); the Harvard School of Public Health, Boston, Mass (Dr Walker); and Ciba-Geigy Pharmaceuticals, Summit, NJ (Dr Bortnichak). Dr Bortnichak is now affiliated with Berlex Laboratories Inc, Wayne, NJ.

Arch Intern Med. 1995;155(13):1371-1377. doi:10.1001/archinte.1995.00430130043005

Background:  Nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with an elevated risk of peptic ulcer and upper gastrointestinal hemorrhage, but published reports have lacked information on rates of outpatient disease, have concentrated on the elderly, and have not provided comparisons of rates for specific types of NSAIDs.

Methods:  We compared incidence rates of peptic ulcer and upper gastrointestinal hemorrhage in 68 028 people younger than 65 years who used diclofenac sodium, naproxen, piroxicam, or sulindac, and who were members of a network of health maintenance organizations. We reviewed automated insurance claims data and medical records to ascertain cases and included conditions treated on an outpatient basis.

Results:  Medical claims data were adequate for crude identification of potential cases, but review of medical records led to rejection of 63% of these, representing either no abnormality or diseases other than peptic ulcer or upper gastrointestinal hemorrhage. Of the total 112 cases, 64 (57%) were treated as outpatients. The crude incidence rate per 1000 person-years in users of any current, recent, or past NSAID was 2.2 and in distant-past users of NSAIDs was 0.75. For diclofenac, naproxen, piroxicam, and sulindac, we found a consistent pattern of decreasing NSAID effects from current to recent to past exposure. The risk of peptic ulcer or upper gastrointestinal hemorrhage was 1.6 cases per 1000 people using NSAIDs.

Conclusions:  Combining use of automated claims records with review of medical records promotes efficiency while maintaining specificity of case ascertainment. This study, with 57% of cases treated as outpatients, had results consistent with other published reports that were based on hospitalized patients. Within the limits of statistical error, the incidence rates of peptic ulcer and upper gastrointestinal hemorrhage appeared to be similar for the various NSAIDs studied.(Arch Intern Med. 1995;155:1371-1377)