title: Low frequency of upper gastrointestinal complications in a cohort of high-risk patients taking low-dose aspirin or NSAIDS and omeprazole.
abstract: 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.
authors.affiliation: Service of Digestive Diseases, University Hospital Lozano Blesa, Zaragoza, Spain. alanas@posta.unizar.es
authors.forename: A
authors.initials: A
authors.lastname: Lanas
authors.forename: L
authors.initials: L
authors.lastname: Rodrigo
authors.forename: J L
authors.initials: JL
authors.lastname: Márquez
authors.forename: E
authors.initials: E
authors.lastname: Bajador
authors.forename: F
authors.initials: F
authors.lastname: Pérez-Roldan
authors.forename: J
authors.initials: J
authors.lastname: Cabrol
authors.forename: E
authors.initials: E
authors.lastname: Quintero
authors.forename: M
authors.initials: M
authors.lastname: Montoro
authors.forename: F
authors.initials: F
authors.lastname: Gomollón
authors.forename: S
authors.initials: S
authors.lastname: Santolaria
authors.forename: S
authors.initials: S
authors.lastname: Lorente
authors.forename: M
authors.initials: M
authors.lastname: Cucala
authors.forename: J
authors.initials: J
authors.lastname: Nuevo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000453:epidemiology; D006471:Gastrointestinal Hemorrhage / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000627:therapeutic use*; D010437:Peptic Ulcer / Q000188:drug therapy; D011446:Prospective Studies; D012307:Risk Factors; D013997:Time Factors
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D009853:Omeprazole; D001241:Aspirin