title: Short-term acetylsalicylic acid (aspirin) use for pain, fever, or colds - gastrointestinal adverse effects: a meta-analysis of randomized clinical trials.
abstract: OBJECTIVE
  Acetylsalicylic acid (ASA [aspirin]) is a commonly used over-the-counter drug for the treatment of pain, fever, or colds, but data on the safety of this use are very limited. The aim of this study was to provide data on the safety of this treatment pattern, which is of interest to clinicians, regulators, and the public.
  
  
  METHODS
  A meta-analysis of individual patient data from 67 studies sponsored by Bayer HealthCare was completed. The primary endpoints were patient-reported gastrointestinal (GI) adverse events (AEs); the secondary endpoints were the incidence of patient-reported non-GI AEs. Event incidence and odds ratios (ORs) based on Cochran-Mantel-Haenszel estimates are reported. In total, 6181 patients were treated with ASA, 3515 with placebo, 1145 with acetaminophen (paracetamol), and 754 with ibuprofen. Exposure to ASA was short term (82.5% of patients had a single dose).
  
  
  RESULTS
  GI AEs were more frequent with ASA (9.9%) than with placebo (9.0%).[OR 1.3; 95% CI 1.1, 1.5]. Dyspeptic symptoms were infrequent (4.6% in placebo subjects). The ORs for ASA were 1.3 (95% CI 1.1, 1.6) versus placebo; 1.55 (95% CI 0.7, 3.3) versus ibuprofen; and 1.04 (95% CI 0.8, 1.4) versus acetaminophen. There were very few serious GI AEs (one ASA case; three placebo cases). No differences were found for non-GI AEs and no cases of cerebral hemorrhage were reported.
  
  
  CONCLUSIONS
  Short-term, mostly single-dose exposure to ASA for the treatment of pain, fever, or colds was associated with a small but significant increase in the risk of dyspepsia relative to placebo. No serious GI complications were reported.
authors: University of Zaragoza Medical School, Aragn Health Research Institute (IIS Aragn), CIBERehd, Zaragoza, Spain. alanas@unizar.es
authors: Angel
authors: A
authors: Lanas
authors: Denis
authors: D
authors: McCarthy
authors: Michael
authors: M
authors: Voelker
authors: Andreas
authors: A
authors: Brueckner
authors: Stephen
authors: S
authors: Senn
authors: John A
authors: JA
authors: Baron
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects*; D003139:Common Cold / Q000188:drug therapy*; D004311:Double-Blind Method; D004415:Dyspepsia / Q000139:chemically induced*; D005260:Female; D005334:Fever / Q000188:drug therapy*; D005767:Gastrointestinal Diseases / Q000139:chemically induced*; D041981:Gastrointestinal Tract / Q000187:drug effects; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use; D008297:Male; D016017:Odds Ratio; D010146:Pain / Q000188:drug therapy*; D010919:Placebos; D016032:Randomized Controlled Trials as Topic
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010919:Placebos; D000082:Acetaminophen; D001241:Aspirin; D007052:Ibuprofen