title: Non-steroidal anti-inflammatory drugs and ulcer complications: a risk factor analysis for clinical decision-making.
abstract: BACKGROUND
  Use of non-steroidal anti-inflammatory drugs (NSAIDs) is recognized as an important cause of peptic ulcer complications. The aim of this nested case-control study was to identify risk factors for NSAID-related ulcer complications.
  
  
  METHODS
  Cases were consecutive NSAID users admitted with an ulcer complication (n = 118), and controls were a random sample of all NSAID users without ulcer complication identified by a pharmacoepidemiologic database (n = 540).
  
  
  RESULTS
  Ninety-four of 118 cases were interviewed, and 324 of 540 controls answered the questionnaire. Analysis showed no difference between included and non-included subjects. Risk factors for patients at start of NSAID therapy were high age: 60-75 years (odds ratio (OR), 3.5 (95% confidence interval (Cl), 1.8-7.1); > 75 years (OR, 8.9 (4.3-18.3)); male sex (OR 1.7 (1.0-3.0)); ulcer history (OR 2.5 (1.2-5.1)); steroid treatment (OR 2.0 (0.8-4.6)); smoking (OR 1.6 (0.9-2.7)); and alcohol use (OR 1.8 (0.9-3.6)). Risk factors for patients receiving NSAID therapy were high age, male sex, ulcer history, smoking and, furthermore, dyspepsia (OR 2.0 (1.0-4.2)), especially NSAID-related dyspepsia (OR 8.7 (4.0-18.9)). Risk was lower for patients treated more than 3 months.
  
  
  CONCLUSIONS
  Risk measured from this design can be shown to correlate strongly with the rate difference, a measure that is more clinically relevant than conventional relative risk estimates. Strong risk factors for NSAID-related ulcer complication are high age, male sex, ulcer history, and dyspepsia related to the NSAID therapy. Avoiding NSAID therapy in these high-risk patients, whenever possible, might prevent many adverse events.
authors.affiliation: Dept. of Medical Gastroenterology, Odense University Hospital, Denmark.
authors.forename: J M
authors.initials: JM
authors.lastname: Hansen
authors.forename: J
authors.initials: J
authors.lastname: Hallas
authors.forename: J M
authors.initials: JM
authors.lastname: Lauritsen
authors.forename: P
authors.initials: P
authors.lastname: Bytzer
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000428:Alcohol Drinking / Q000009:adverse effects; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects*; D016022:Case-Control Studies; D016001:Confidence Intervals; D004381:Duodenal Ulcer / Q000139:chemically induced* / Q000453:epidemiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011358:Product Surveillance, Postmarketing; D012307:Risk Factors; D012494:Sampling Studies; D012907:Smoking / Q000009:adverse effects; D013256:Steroids; D013276:Stomach Ulcer / Q000139:chemically induced* / Q000453:epidemiology
chemical_list: D000893:Anti-Inflammatory Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D013256:Steroids