Gastrointestinal Adverse Effects of Short-Term Aspirin Use: A Meta-Analysis of Published Randomized Controlled Trials

Abstract

Background and ObjectivesAspirin is widely used for short-term treatment of pain, fever or colds, but there are only limited data regarding the safety of this use. To summarize the available data on this topic, we conducted a meta-analysis of the published clinical trial literature regarding the gastrointestinal adverse effects of short-term use of aspirin in comparison with placebo and other medications commonly used for the same purpose.Data Sources and MethodsAn extensive literature search identified 119,310 articles regarding possible adverse effects of aspirin, among which 23,131 appeared to possibly include relevant data. An automated text-mining procedure was used to score the references for potential relevance for the meta-analysis. The 3,983 highest-scoring articles were reviewed individually to identify those with data that could be included in this analysis. Ultimately, 78 relevant articles were identified that contained gastrointestinal adverse event data from clinical trials of aspirin versus placebo or an active comparator. Odds ratios (ORs) computed using a Mantel–Haenszel estimator were used to summarize the comparative effects on dyspepsia, nausea/vomiting, and abdominal pain, considered separately and also aggregated as ‘minor gastrointestinal events’. Gastrointestinal bleeds, ulcers, and perforations were also investigated.ResultsData were obtained regarding 19,829 subjects (34 % treated with aspirin, 17 % placebo, and 49 % an active comparator). About half of the aspirin subjects took a single dose. Aspirin was associated with a higher risk of minor gastrointestinal events than placebo or active comparators: the summary ORs were 1.46 (95 % confidence interval [CI] 1.15–1.86) and 1.81 (95 % CI 1.61–2.04), respectively. Ulcers, perforation, and serious bleeding were not seen after use of aspirin or any of the other interventions.ConclusionsDuring short-term use, aspirin is associated with a higher frequency of gastrointestinal complaints than other medications commonly used for treatment of pain, colds, and fever. Serious adverse events were not observed with aspirin or any of the comparators.Electronic supplementary materialThe online version of this article (doi:10.1007/s40268-013-0011-y) contains supplementary material, which is available to authorized users.

Differing disintegration and dissolution rates, pharmacokinetic profiles and gastrointestinal tolerability of over the counter ibuprofen formulations

“…Secondly, whether the 30% increase in C max with the ibuprofen salt and liquid gelatine capsule formulations is associated with a decrease in gastrointestinal tolerability as suggested by Brune et al . This is difficult to assess by conventional methods as the gastrointestinal tolerability of OTC ibuprofen is similar to placebo in a range of robust clinical studies . Nevertheless, postmarketing data might identify rare side effects that are sufficiently severe for patients to report them.…”

“…A meta‐analysis of eight placebo‐controlled trials showed that gastrointestinal tolerability with OTC doses of ibuprofen (87.9%) did not differ significantly from placebo (89%) . A number of well‐designed studies confirm this apparent good gastrointestinal tolerability . However, these studies do not take account of the different formulations of NSAID ingested, which have different physicochemical properties and consequently different pharmacokinetic and pharmacodynamic profiles.…”

“…[11] A number of well-designed studies confirm this apparent good gastrointestinal tolerability. [9,[12][13][14] However, these studies do not take account of the different formulations of NSAID ingested, which have different physicochemical properties and consequently different pharmacokinetic and pharmacodynamic profiles.…”

An advanced review on text mining in medicine

“…Baron et al () performed a meta‐analysis to identify adverse effects of aspirin usage, considering TM (Gupta et al, ) as an automated procedure to score articles for potential relevance to a posteriori meta‐analysis. A total of 119,310 articles were considered so TM highly eased the arduous labor required if these articles were analyzed at hand.…”

Superselective Transarterial Embolization for Lower Gastrointestinal Bleeding: An Analysis of its Effectiveness and Safety

“…About 10 -15% of patients with life-threatening hemorrhage require invasive interventions for hemostasis, and approximately 4% of patients die from LGI bleeding (2,3). The incidence of LGI bleeding also increases with the usage of aspirin, nonsteroidal antiinflammatory drugs, and anticoagulants (4)(5)(6).…”