TY - JOUR
T1 - Short-term acetylsalicylic acid (aspirin) use for pain, fever, or colds - Gastrointestinal adverse effects
T2 - A meta-analysis of randomized clinical trials
AU - Lanas, Angel
AU - McCarthy, Denis
AU - Voelker, Michael
AU - Brueckner, Andreas
AU - Senn, Stephen
AU - Baron, John A.
N1 - Funding Information:
Angel Lanas received an honorarium from Bayer for conducting this study and preparing the manuscript. He has also consulted for Pfizer, AstraZeneca and Nicox. He has received honoraria and grants from Pfizer and AstraZeneca. Denis McCarthy, Stephen Senn and John Baron consulted for Bayer during this study. Stephen Senn received honoraria from Bayer for providing advice during this study. John Baron has previously received a grant from Bayer for a meta-analysis on aspirin. John Baron jointly holds a patent for aspirin as a chemopreventing agent for colorectal adenomas. Andreas Brueckner and Michael Voelker are employees of Bayer HealthCare.
PY - 2011
Y1 - 2011
N2 - 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.
AB - 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.
KW - Adverse-drug-reactions
KW - Aspirin
KW - Common-cold
KW - Meta-analysis
KW - Pain
UR - http://www.scopus.com/inward/record.url?scp=80052705302&partnerID=8YFLogxK
U2 - 10.2165/11593880-000000000-00000
DO - 10.2165/11593880-000000000-00000
M3 - Article
C2 - 21902288
AN - SCOPUS:80052705302
SN - 1174-5886
VL - 11
SP - 277
EP - 288
JO - Drugs in R and D
JF - Drugs in R and D
IS - 3
ER -