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.
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.
| Original language | English |
|---|---|
| Pages (from-to) | 1183-1187 |
| Number of pages | 5 |
| Journal | BMJ-British Medical Journal |
| Volume | 321 |
| Issue number | 7270 |
| DOIs | |
| Publication status | Published - 2000 |