PMID- 27449765
OWN - NLM
STAT- MEDLINE
DCOM- 20170612
LR  - 20181113
IS  - 1179-6901 (Electronic)
IS  - 1174-5886 (Print)
IS  - 1174-5886 (Linking)
VI  - 16
IP  - 3
DP  - 2016 Sep
TI  - Gastrointestinal Safety of Aspirin for a High-Dose, Multiple-Day Treatment 
      Regimen: A Meta-Analysis of Three Randomized Controlled Trials.
PG  - 263-269
AB  - BACKGROUND AND AIM: Aspirin is a commonly used over-the-counter (OTC) agent for 
      the symptomatic treatment of acute pain, fever, or the common cold, but data 
      regarding safety in this context are limited. In order to characterize the safety 
      of aspirin beyond single-dose or long-term use data, we conducted a meta-analysis 
      of multiple-dose, multiple-day studies of OTC aspirin at a label-approved dosage. 
      METHODS: We conducted a meta-analysis of individual patient data from three 
      Bayer-sponsored studies. The meta-analysis was performed in 2015; the individual 
      studies were conducted between 2008 and 2012 and were of a randomized, 
      parallel-group, placebo-controlled design. Patients received a minimum dosage of 
      aspirin of 2000 mg/day over at least 3 days. The endpoints were patient-reported 
      adverse events (AEs) with an emphasis on the system organ class gastrointestinal 
      system. Event incidences were estimated and an analysis of the odds ratios (ORs) 
      and risk differences (RDs) of aspirin versus placebo were performed. RESULTS: Of 
      the 819 patients included, 433 were treated with aspirin and 386 were treated 
      with placebo. The majority of patients (85.7 %) received a median dose of aspirin 
      of 3000 mg/day for 3 days. The incidence of the overall AEs was low and rates 
      were comparable between the aspirin (10.9 %) and placebo (12.4 %) groups [OR: 
      0.86 (95 % confidence interval [CI] 0.56, 1.34); RD: -1.49 (95 % CI -6.01, 
      3.03)]. Gastrointestinal AEs were more common in subjects treated with aspirin 
      (7.4 %) than with placebo (5.4 %), and although this difference did not reach 
      statistical significance, a trend towards increased risk was observed with 
      aspirin use [OR: 1.41 (95 % CI 0.78, 2.54); RD: 2.00 (95 % CI -1.35, 5.35)]. 
      Nausea, upper abdominal pain, dyspepsia, and diarrhea were the most frequently 
      reported gastrointestinal AEs. There were no reports of serious gastrointestinal 
      complications such as bleeding, perforation, or ulceration. CONCLUSIONS: The 
      multiple-dose regimen of aspirin used for several days according to the OTC label 
      is well-tolerated by otherwise healthy non-elderly subjects for short-term and 
      symptomatic treatment of pain, fever, and the common cold. There were no reports 
      of serious gastrointestinal complications in either of the groups.
FAU - Forder, Samantha
AU  - Forder S
AD  - Bayer, Whippany, NJ, USA.
FAU - Voelker, Michael
AU  - Voelker M
AD  - Bayer, Leverkusen, Germany. michael.voelker@bayer.com.
FAU - Lanas, Angel
AU  - Lanas A
AD  - IIS Aragon, CIBERehd, University of Zaragoza, Zaragoza, Spain.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PL  - New Zealand
TA  - Drugs R D
JT  - Drugs in R&D
JID - 100883647
RN  - R16CO5Y76E (Aspirin)
SB  - IM
MH  - Abdominal Pain/chemically induced
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Aspirin/*administration & dosage/*adverse effects
MH  - Female
MH  - Gastrointestinal Diseases/*drug therapy
MH  - Heartburn/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Randomized Controlled Trials as Topic
MH  - Vomiting/chemically induced
MH  - Young Adult
PMC - PMC5045830
COIS- Compliance with Ethical Standards This study was funded by Bayer AG, Leverkusen, 
      Germany, and performed by M.A.R.C.O., Dusseldorf, Germany, an independent 
      institute for clinical research and statistics. During the development of this 
      manuscript, Samantha Forder was completing a post-doctoral fellowship through a 
      partnership between Bayer and Rutgers University, New Brunswick, NJ, USA. Michael 
      Voelker is a full-time employee of Bayer AG. Angel Lanas is supported by the 
      University of Zaragoza, Zaragoza, Spain. Dr. Lanas has received honoraria for 
      participation in advisory boards and for a previous related study from Bayer. All 
      authors contributed sufficiently to the development, review, and revision of this 
      manuscript.
EDAT- 2016/07/28 06:00
MHDA- 2017/06/13 06:00
PMCR- 2016/07/23
CRDT- 2016/07/25 06:00
PHST- 2016/07/28 06:00 [pubmed]
PHST- 2017/06/13 06:00 [medline]
PHST- 2016/07/25 06:00 [entrez]
PHST- 2016/07/23 00:00 [pmc-release]
AID - 10.1007/s40268-016-0138-8 [pii]
AID - 138 [pii]
AID - 10.1007/s40268-016-0138-8 [doi]
PST - ppublish
SO  - Drugs R D. 2016 Sep;16(3):263-269. doi: 10.1007/s40268-016-0138-8.