What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Upper gastrointestinal bleeding (n=87366). Intervention: Low-dose acetylsalicylic acid (LDA) vs. Placebo or controls without UGIB. Primary outcome: Upper gastrointestinal bleeding (UGIB) risk (OR 1.5, 95% CI 1.2 to 1.8).

What does this research mean for the field?

Low-dose acetylsalicylic acid use is associated with an increased risk of upper gastrointestinal bleeding across both randomized clinical trials (OR 1.5) and observational studies (OR 3.1). Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

January 1, 2013Open Access

Low-Dose Acetylsalicylic Acid Use and the Risk of Upper Gastrointestinal Bleeding: A Meta-Analysis of Randomized Clinical Trials and Observational Studies

Key Result

Low-dose acetylsalicylic acid use was associated with an increased risk of upper gastrointestinal bleeding in both RCTs (OR 1.5; 95% CI 1.2-1.8) and observational studies (OR 3.1; 95% CI 2.5-3.7).

Study Design

Type

Meta-Analysis (n=87,366)

Structured PICO

Does low-dose acetylsalicylic acid increase the risk of upper gastrointestinal bleeding?

Population

18 studies (7 RCTs, 10 case-control, 1 cohort) pooling 87,366 individuals. RCTs included 22,901 receiving LDA and 22,923 receiving placebo. Case-control studies included 10,816 UGIB cases and 30,519 controls. Cohort study included 207 UGIB cases.

Intervention

Low-dose acetylsalicylic acid (LDA, 75 mg/day to 325 mg/day)

Comparator

Placebo (in RCTs) or controls without UGIB (in case-control studies)

Outcome

Upper gastrointestinal bleeding (UGIB) ratessafety

Low-dose aspirin use is associated with a 50% increased risk of upper gastrointestinal bleeding in RCTs, translating to 1.2 extra cases per 1000 patients per year.

Main Result

Effect estimate: OR 1.5 (95% CI 1.2 to 1.8)

Abstract

BACKGROUND: Low-dose acetylsalicylic acid (LDA, 75 mg/day to 325 mg/day) is recommended for primary and secondary prevention of cardiovascular events, but has been linked to an increased risk of upper gastrointestinal bleeding (UGIB). OBJECTIVE: To analyze the magnitude of effect of LDA use on UGIB risk. METHODS: The PubMed and Embase databases were searched for randomized controlled trials (RCTs) reporting UGIB rates in individuals receiving LDA, and observational studies of LDA use in patients with UGIB. Studies were pooled for analysis of UGIB rates. RESULTS: Eighteen studies were included. Seven RCTs reported UGIB rates in individuals randomly assigned to receive LDA (n=22,901) or placebo (n=22,923). Ten case-control studies analyzed LDA use in patients with UGIB (n=10,816) and controls without UGIB (n=30,519); one cohort study reported 207 UGIB cases treated with LDA only. All studies found LDA use to be associated with an increased risk of UGIB. The mean number of extra UGIB cases associated with LDA use in the RCTs was 1.2 per 1000 patients per year (95% CI 0.7 to 1.8). The number needed to harm was 816 (95% CI 560 to 1500) for RCTs and 819 (95% CI 617 to 1119) for observational studies. Meta-analysis of RCT data showed that LDA use was associated with a 50% increase in UGIB risk (OR 1.5 95% CI 1.2 to 1.8). UGIB risk was most pronounced in observational studies (OR 3.1 95% CI 2.5 to 3.7). CONCLUSIONS: LDA use was associated with an increased risk of UGIB.

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