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Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial

Citation

Mahady, SE and Margolis, KL and Chan, A and Polekhina, G and Woods, RL and Wolfe, R and Nelson, MR and Lockery, JE and Wood, EM and Reid, C and Ernst, ME and Murray, A and Thao, LTP and McNeil, JJ, Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial, Gut pp. 1-8. ISSN 0017-5749 (2020) [Refereed Article]

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Copyright 2020 Author(s) (or their employer(s))

DOI: doi:10.1136/gutjnl-2020-321585

Abstract

Objective: There 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.

Design: Data 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.

Results: Over 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.

Conclusion: Aspirin 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.

Item Details

Item Type:Refereed Article
Keywords:aspirin, clinical trials, elderly, epidemiology, gastrointestinal bleeding
Research Division:Health Sciences
Research Group:Epidemiology
Research Field:Epidemiology not elsewhere classified
Objective Division:Health
Objective Group:Specific population health (excl. Indigenous health)
Objective Field:Health related to ageing
UTAS Author:Nelson, MR (Professor Mark Nelson)
ID Code:140643
Year Published:2020
Web of Science® Times Cited:1
Deposited By:Menzies Institute for Medical Research
Deposited On:2020-09-01
Last Modified:2021-03-18
Downloads:0

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