Risk of Gastrointestinal Bleeding for Aspirin Users: Comprehensive Review and Meta Analysis of Randomized Control Trials (RCTS)

OBJECTIVES:

Low-dose aspirin (LDA) may be beneficial due to its antiplatelet effects. However, LDA is associated with an increased risk of gastrointestinal bleeding (GIB), particularly in older adults. Systematic reviews have been conducted to investigate the relationship between LDA and GIB, but those reviews are now incomplete because new evidence has been published. Thus, the objective of this study was to conduct a systematic review of risk for GIB after exposure to LDA compared to placebo.

METHODS:

A systematic search was conducted for studies evaluating the risk of GIB after aspirin exposure that were published through September 2023. To identify articles of interest, previous meta-analyses were examined for eligible studies. PubMed, Scopus, Web of Science, and Embase were searched to identify additional studies from 2018 to 2023, as the recent meta-analyses contained articles through September 2018. Inclusion criteria were randomized controlled trials (RCT) with an aspirin dose of less than 325 mg compared with a placebo, and the incidence of GIB was reported. GIB was defined as any bleeding in the upper or lower gastrointestinal tract. A random effects model was employed to pool studies and calculate an effect size. Heterogeneity was assessed using I².

RESULTS:

Eleven metanalyses have been conducted on the topic. Additional literature searches identified 870 publications that were assessed for inclusion. A total of 51 studies examining 225,650 individuals were included in the analysis. A significant increase in the risk of GIB associated with LDA use (OR = 1.63, 95% Confidence interval = [1.41 – 1.89]. Heterogeneity in the pooled estimate was modest with an I² of 56%.

CONCLUSIONS:

The results of this meta-analysis quantify the risk of GIB associated with LDA. These findings emphasize the significance of assessing the risk-benefit ratio of aspirin therapy, especially in high-risk groups.