Key result
Short-term, mostly single-dose exposure to acetylsalicylic acid for pain, fever, or colds was associated with a small but significant increase in the risk of gastrointestinal adverse events compared to placebo (OR 1.3).
Why the study?
Does short-term acetylsalicylic acid increase patient-reported gastrointestinal adverse events compared to placebo or active comparators in patients with pain, fever, or colds?
Meta-Analysis (n=13,222)
Mixed (Double-blind, single-blind, open-label)
Randomized
Yes
Does short-term acetylsalicylic acid increase patient-reported gastrointestinal adverse events compared to placebo or active comparators in patients with pain, fever, or colds?
Effect estimate: OR 1.3 (95% CI 1.1, 1.5)
Absolute Event Rate: 9.9% vs 9%
Short-term, mostly single-dose use of aspirin for pain, fever, or colds is associated with a small increase in dyspepsia but no serious GI complications compared to placebo.
May prompt counseling on mild GI symptoms even with single-dose aspirin; confirms small risk increase without serious events.
BACKGROUND AND AIM: Acetylsalicylic acid (ASA [aspirin]) is a commonly used over-the-counter drug for the treatment of pain, fever, or colds, but data on the safety of this use are very limited. The aim of this study was to provide data on the safety of this treatment pattern, which is of interest to clinicians, regulators, and the public. METHODS: A meta-analysis of individual patient data from 67 studies sponsored by Bayer HealthCare was completed. The primary endpoints were patient-reported gastrointestinal (GI) adverse events (AEs); the secondary endpoints were the incidence of patient-reported non-GI AEs. Event incidence and odds ratios (ORs) based on Cochran-Mantel-Haenszel estimates are reported. In total, 6181 patients were treated with ASA, 3515 with placebo, 1145 with acetaminophen (paracetamol), and 754 with ibuprofen. Exposure to ASA was short term (82.5% of patients had a single dose). RESULTS: GI AEs were more frequent with ASA (9.9%) than with placebo (9.0%).[OR 1.3; 95% CI 1.1, 1.5]. Dyspeptic symptoms were infrequent (4.6% in placebo subjects). The ORs for ASA were 1.3 (95% CI 1.1, 1.6) versus placebo; 1.55 (95% CI 0.7, 3.3) versus ibuprofen; and 1.04 (95% CI 0.8, 1.4) versus acetaminophen. There were very few serious GI AEs (one ASA case; three placebo cases). No differences were found for non-GI AEs and no cases of cerebral hemorrhage were reported. CONCLUSION: Short-term, mostly single-dose exposure to ASA for the treatment of pain, fever, or colds was associated with a small but significant increase in the risk of dyspepsia relative to placebo. No serious GI complications were reported.
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Lanas et al. (2011) conducted a meta-analysis in Pain, fever, or colds (n=13,222). Acetylsalicylic acid (Aspirin) vs. Placebo was evaluated on Patient-reported gastrointestinal (GI) adverse events (OR 1.3, 95% CI 1.1, 1.5). Short-term, mostly single-dose exposure to acetylsalicylic acid for pain, fever, or colds was associated with a small but significant increase in the risk of gastrointestinal adverse events compared to placebo (OR 1.3).
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