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

BMJ 2000; 321 doi: https://doi.org/10.1136/bmj.321.7270.1183 (Published 11 November 2000) Cite this as: BMJ 2000;321:1183
  1. Sheena Derry, research assistant,
  2. Yoon Kong Loke, clinical lecturer in clinical pharmacology (yoon.loke{at}clinpharm.ox.ac.uk)
  1. Department of Clinical Pharmacology, University of Oxford, Radcliffe Infirmary, Oxford OX2 6HE
  1. Correspondence to: Y K Loke
  • Accepted 15 August 2000

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.

Footnotes

  • Funding SD was supported by a grant from the Sir Jules Thorne Trust.

  • Competing interests None declared.

  • Embedded Image A further table and figure plus the references for the included studies appear on the BMJ's website

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