Risk of gastrointestinal haemorrhage with long term use of aspirin: meta-analysis

BMJ. 2000 Nov 11;321(7270):1183-7. doi: 10.1136/bmj.321.7270.1183.

Abstract

Objectives: To assess the incidence of gastrointestinal haemorrhage associated with long term aspirin therapy and to determine the effect of dose reduction and formulation on the incidence of such haemorrhage.

Design: Meta-analysis of 24 randomised controlled trials (almost 66 000 participants).

Intervention: Aspirin compared with placebo or no treatment, for a minimum of one year.

Main outcome measures: Incidence of gastrointestinal haemorrhage.

Results: Gastrointestinal haemorrhage occurred in 2.47% of patients taking aspirin compared with 1.42% taking placebo (odds ratio 1.68; 95% confidence interval 1.51 to 1.88); the number needed to harm was 106 (82 to 140) based on an average of 28 months' therapy. At doses below 163 mg/day, gastrointestinal haemorrhage occurred in 2.30% of patients taking aspirin compared with 1.45% taking placebo (1.59; 1.40 to 1.81). Meta-regression showed no relation between gastrointestinal haemorrhage and dose. For modified release formulations of aspirin the odds ratio was 1.93 (1.15 to 3.23).

Conclusions: Long term therapy with aspirin is associated with a significant increase in the incidence of gastrointestinal haemorrhage. No evidence exists that reducing the dose or using modified release formulations would reduce the incidence of gastrointestinal haemorrhage.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aspirin / administration & dosage
  • Aspirin / adverse effects*
  • Cyclooxygenase Inhibitors / adverse effects*
  • Dose-Response Relationship, Drug
  • Fibrinolytic Agents / administration & dosage
  • Fibrinolytic Agents / adverse effects*
  • Gastrointestinal Hemorrhage / chemically induced*
  • Humans
  • Long-Term Care
  • Odds Ratio
  • Randomized Controlled Trials as Topic
  • Risk Factors

Substances

  • Cyclooxygenase Inhibitors
  • Fibrinolytic Agents
  • Aspirin