Background Severe upper gastrointestinal (GI) complications such as perforation, ulcer or bleeding are associated with the use of nonsteroidal antiinflammatory drugs (NSAIDs). Most adverse drug reactions (ADRs) related to NSAIDs are non-life threatening, yet they represent a considerable amount of healthcare resource use.
Objectives Evaluate the use of health care resources associated with GI complications among NSAID users in Italy.
Methods From December 1998 to June 1999, 103 general practitioners in the Sicily region of Italy were asked to record data in 10 consecutive days on all patients who visited their offices. Physicians were instructed to fill out data collection forms regarding the type and indication of NSAIDs used and the use of medical resources (eg physician visits, specialist consultations, diagnostic tests, and hospitalizations) related to NSAIDs in general practice for the 6-month period prior to the visit. Physicians were also asked to indicate whether any patient visits during the past six months were related to NSAID ADRs.
Results A total of 913 NSAID users were identified among 20,668 patients who visited the physicians’ offices. The mean age of the patients was 61 years and 61% were females. About 47% filled more than one NSAID prescription during the 6-month period prior to the visit. Of all NSAID users, 50.3% used at least one GI protective agent (including proton pump inhibitors, H2-antagonists, misoprostol and prescription or OTC antacids). There were on average five physician visits per patient. Of all physician visits, 49% were for the pathology for which an NSAID was prescribed, and 5% were due to NSAID ADRs experienced by 23% of the patients. NSAID ADR occurrence was significantly associated with the number of NSAID prescriptions filled (OR: 1.5; 95% CI: 1.3–1.8). The most common NSAID ADRs were upper abdominal pain in 13% of the patients, heartburn in 9%, and dyspepsia in 2%, while other NSAID ADRs occurred in 2% of the patients. Among all NSAID users, 4% had a GI endoscopic exam, 20% had a specialist consultation, 5% were hospitalised, and 31% had an X-ray. Compared to the patients who did not report any visits due to NSAID ADRs, those with NSAID ADRs were more likely to have a GI endoscopic exam (OR: 13.7; 95% CI: 6.4–29.3), a specialist visit (OR: 2.0: 95% CI: 1.4–2.9), hospitalisation (OR: 2.0; 95% CI: 1.1–3.8), and X-ray (OR: 1.4; 95% CI: 1.0–2.0).
Conclusion NSAID related adverse drug reactions were relatively common in this group of NSAID users and resulted in the consumption of a considerable amount of healthcare resources, such as physician visits, specialist consultations, diagnostic tests, and hospitalizations.
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