Short-Term Acetylsalicylic Acid (Aspirin) Use for Pain, Fever, or Colds —Gastrointestinal Adverse Effects

Abstract

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.

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

“…In analyses using broader definitions, the RRs were more modest. Aside from a previous analysis of Bayer-sponsored trials [7], we are unaware of any previous overview of the adverse effects of short-term use of any NSAID, including aspirin.…”

“…Crossover trials were excluded because of concerns regarding unknown carryover effects, patient dropout between treatment phases, and within-patient correlations. To avoid including previously reported data, publications describing Bayer-sponsored studies that were included in a previous report [7] were also not included in the current analysis. After these exclusions, a total of 152 studies from 150 publications were considered.…”

“…We aimed to summarize the gastrointestinal toxicity of aspirin in comparison both with placebo and with other drugs commonly used in this manner, by conducting a meta-analysis of randomized clinical trial data bearing on the issue. This report is a companion to a recent summary using individual subject data on the relative toxicity of aspirin in short-term trials conducted by Bayer [7]. …”

Impact of genetic polymorphisms on adenoma recurrence and toxicity in a COX2 inhibitor (celecoxib) trial

“…For celecoxib, patients taking 200 and 400 mg daily in the APC trial had a 2.6- and 3.4-fold increased risk for adverse cardiovascular events, respectively, compared with those on placebo, whereas a nonstatistically significant 1.3-fold increased risk for adverse cardiovascular events was reported in the PreSAP trial. Another safety endpoint was gastrointestinal toxi-city, which is a major limiting factor for the use of COX1 acetylators, such as aspirin [8–10], but is not associated with celecoxib use [1,2,11]. The final results from the APPROVe trial [3] and the APC and PreSAP trials [11,12] revealed that the drugs are effective in reducing adenoma recurrence, particularly advanced adenomas, but the toxicities, mainly cardiovascular, remain.…”

A Comparison of the Efficacy and Safety of Non-Steroidal Anti-Inflammatory Drugs versus Acetaminophen in Symptom Relief for the Common Cold: A Meta-Analysis of Randomized Controlled Trial Studies

“…On the other hand, not many adverse effects were reported with acetaminophen at normal dosage, and it was reported to have relatively less gastrointestinal adverse effects than NSAIDs 13). Until now, the choice between two medications to mitigate the symptoms of the common cold has been made according to the characteristics and preference of the doctor or the patient, and there has not been a meta-analysis of randomized controlled studies that comprehensively compared the effects of the two medications.…”