Low Frequency of Upper Gastrointestinal Complications in a Cohort of High-Risk Patients Taking Low-Dose Aspirin or NSAIDS and Omeprazole

• Published in: Scandinavian journal of gastroenterology 2003-07, Vol.38 (7), p.693-700
• Main Authors: LANAS, A, RODRIGO, L, LORENTE, S, CUCALA, M, NUEVO, J, MARQUEZ, J. L, BAJADOR, E, PEREZ-ROLDAN, F, CABROL, J, QUINTERO, E, MONTORO, M, GOMOLLON, F, SANTOLARIA, S
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Ulcer Agents - administration & dosage; Anti-Ulcer Agents - therapeutic use; Aspirin; Aspirin - administration & dosage; Aspirin - adverse effects; Biological and medical sciences; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Female; Gastrointestinal Diseases - chemically induced; Gastrointestinal Diseases - epidemiology; Gastrointestinal Hemorrhage - drug therapy; Humans; Male; Medical sciences; Middle Aged; Non-steroidal Anti-inflammatory Drugs; Omeprazole; Omeprazole - administration & dosage; Omeprazole - therapeutic use; Peptic Ulcer; Peptic Ulcer - drug therapy; Prospective Studies; Risk Factors; Time Factors; Ulcer Bleeding
• ISSN: 0036-5521; 1502-7708
• DOI: 10.1080/00365520310003967

Background: There is very little information available on the incidence of complications and on the best prevention therapy in high-risk patients taking non-steroidal anti-inflammatory drugs (NSAIDs) and/or aspirin. Randomized-controlled trials in such patients are rare for ethical reasons. We studied the incidence of gastrointestinal complications in high-risk patients taking long-term low-dose aspirin or non-aspirin-NSAIDs combined with omeprazole in a real-life clinical setting. Methods: This was a multicentre, prospective and observational study including 247 consecutive high-risk patients who had a clinical indication for long-term treatment with either low-dose aspirin or non-aspirin NSAIDs and omeprazole therapy. The occurrence of gastrointestinal complications was measured. Results: In addition to a recent history of peptic ulcer bleeding, all patients had at least 1 other risk factor and 112 (45.3%) had 3 or more risk factors; 78.9% were taking low-dose aspirin and the remainder non-aspirin NSAIDs. Mean follow-up was 14.6 ± 10.38 months. Three patients taking low-dose aspirin developed upper gastrointestinal bleeding (1.2%; 95% CI 0.3-3.5; 1.0 event/100 patients/year). This was similar to the rate observed in studies involving non-high-risk patients taking low-dose aspirin and higher than that observed in patients not taking low-dose aspirin. Two additional patients developed a lower gastrointestinal bleeding event (0.81% (0.04%-3.12%); 0.67 events/100 patients/year), which was within the range expected in NSAID users. Conclusions: The use of omeprazole in the high-risk patient taking low-dose aspirin or NSAIDs seems to be a safe therapeutic approach in this population and is associated with a low frequency of upper gastrointestinal complications.