PMID- 21902288
OWN - NLM
STAT- MEDLINE
DCOM- 20120105
LR  - 20211020
IS  - 1179-6901 (Electronic)
IS  - 1174-5886 (Print)
IS  - 1174-5886 (Linking)
VI  - 11
IP  - 3
DP  - 2011 Sep 1
TI  - Short-term acetylsalicylic acid (aspirin) use for pain, fever, or colds - 
      gastrointestinal adverse effects: a meta-analysis of randomized clinical trials.
PG  - 277-88
LID - 10.2165/11593880-000000000-00000 [doi]
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.
FAU - Lanas, Angel
AU  - Lanas A
AD  - University of Zaragoza Medical School, Aragn Health Research Institute (IIS 
      Aragn), CIBERehd, Zaragoza, Spain. alanas@unizar.es
FAU - McCarthy, Denis
AU  - McCarthy D
FAU - Voelker, Michael
AU  - Voelker M
FAU - Brueckner, Andreas
AU  - Brueckner A
FAU - Senn, Stephen
AU  - Senn S
FAU - Baron, John A
AU  - Baron JA
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Drugs R D
JT  - Drugs in R&D
JID - 100883647
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Placebos)
RN  - 362O9ITL9D (Acetaminophen)
RN  - R16CO5Y76E (Aspirin)
RN  - WK2XYI10QM (Ibuprofen)
SB  - IM
MH  - Acetaminophen/therapeutic use
MH  - Adult
MH  - Anti-Inflammatory Agents, Non-Steroidal/adverse effects/therapeutic use
MH  - Aspirin/*administration & dosage/*adverse effects
MH  - Common Cold/*drug therapy
MH  - Double-Blind Method
MH  - Dyspepsia/*chemically induced
MH  - Female
MH  - Fever/*drug therapy
MH  - Gastrointestinal Diseases/*chemically induced
MH  - Gastrointestinal Tract/drug effects
MH  - Humans
MH  - Ibuprofen/therapeutic use
MH  - Male
MH  - Odds Ratio
MH  - Pain/*drug therapy
MH  - Placebos
MH  - Randomized Controlled Trials as Topic
PMC - PMC3586117
EDAT- 2011/09/10 06:00
MHDA- 2012/01/06 06:00
PMCR- 2012/11/25
CRDT- 2011/09/10 06:00
PHST- 2011/09/10 06:00 [entrez]
PHST- 2011/09/10 06:00 [pubmed]
PHST- 2012/01/06 06:00 [medline]
PHST- 2012/11/25 00:00 [pmc-release]
AID - 4 [pii]
AID - 11030277 [pii]
AID - 10.2165/11593880-000000000-00000 [doi]
PST - ppublish
SO  - Drugs R D. 2011 Sep 1;11(3):277-88. doi: 10.2165/11593880-000000000-00000.