Journal article
Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial
Gut, Vol.70(4), pp.717-724
04/2021
DOI: 10.1136/gutjnl-2020-321585
PMCID: PMC7957959
PMID: 32747412
Abstract
ObjectiveThere is a lack of robust data on significant gastrointestinal bleeding in older people using aspirin. We calculated the incidence, risk factors and absolute risk using data from a large randomised, controlled trial.DesignData were extracted from an aspirin versus placebo primary prevention trial conducted throughout 2010–2017 (‘ASPirin in Reducing Events in the Elderly (ASPREE)’, n=19 114) in community-dwelling persons aged ≥70 years. Clinical characteristics were collected at baseline and annually. The endpoint was major GI bleeding that resulted in transfusion, hospitalisation, surgery or death, adjudicated independently by two physicians blinded to trial arm.ResultsOver a median follow-up of 4.7 years (88 389 person years), there were 137 upper GI bleeds (89 in aspirin arm and 48 in placebo arm, HR 1.87, 95% CI 1.32 to 2.66, p<0.01) and 127 lower GI bleeds (73 in aspirin and 54 in placebo arm, HR 1.36, 95% CI 0.96 to 1.94, p=0.08) reflecting a 60% increase in bleeding overall. There were two fatal bleeds in the placebo arm. Multivariable analyses indicated age, smoking, hypertension, chronic kidney disease and obesity increased bleeding risk. The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors.ConclusionAspirin increases overall GI bleeding risk by 60%; however, the 5-year absolute risk of serious bleeding is modest in younger, well individuals. These data may assist patients and their clinicians to make informed decisions about prophylactic use of aspirin.Trial registration numberASPREE. NCT01038583.
Details
- Title: Subtitle
- Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial
- Creators
- Suzanne E Mahady - Monash UniversityKaren L Margolis - HealthPartnersAndrew Chan - Massachusetts General HospitalGalina Polekhina - Monash UniversityRobyn L Woods - Monash UniversityRory Wolfe - Monash UniversityMark R Nelson - University of TasmaniaJessica E Lockery - Monash UniversityErica M Wood - Monash UniversityChristopher Reid - Curtin UniversityMichael E Ernst - University of IowaAnne Murray - Hennepin Healthcare Research InstituteLTP Thao - Monash UniversityJohn J McNeil - Monash University
- Resource Type
- Journal article
- Publication Details
- Gut, Vol.70(4), pp.717-724
- DOI
- 10.1136/gutjnl-2020-321585
- PMID
- 32747412
- PMCID
- PMC7957959
- NLM abbreviation
- Gut
- ISSN
- 0017-5749
- eISSN
- 1468-3288
- Grant note
- DOI: 10.13039/100000049, name: National Institute on Aging, award: U01AG029824; DOI: 10.13039/100008018, name: Victorian Cancer Agency; name: National Health and Medical Research Council of Australia, award: 1127060, 334047; DOI: 10.13039/501100001232, name: Royal Australasian College of Physicians, award: Vincent Fairfax Family Foundation Research Establi
- Language
- English
- Date published
- 04/2021
- Academic Unit
- Family and Community Medicine; Pharmacy Practice and Science
- Record Identifier
- 9984297348802771
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