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

Autor:	Mahady SE; School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia suzanne.mahady@monash.edu.; Gastroenterology, Melbourne Health, Parkville, Victoria, Australia., Margolis KL; HealthPartners Institute, Minneapolis, Minnesota, USA., Chan A; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA., Polekhina G; School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia., Woods RL; School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia., Wolfe R; School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia., Nelson MR; Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia., Lockery JE; School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia., Wood EM; School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia., Reid C; School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.; School of Public Health, Curtin University, Perth, Western Australia, Australia., Ernst ME; Department of Pharmacy Practice and Science, College of Pharmacy, The University of Iowa, Iowa City, Iowa, USA., Murray A; Division of Geriatrics, Department of Medicine, Hennepin Healthcare, University of Minnesota, Minneapolis, Minnesota, USA.; Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare, Minneapolis, Minnesota, USA., Thao L; School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia., McNeil JJ; School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.
Jazyk:	angličtina
Zdroj:	Gut [Gut] 2021 Apr; Vol. 70 (4), pp. 717-724. Date of Electronic Publication: 2020 Aug 03.
DOI:	10.1136/gutjnl-2020-321585
Abstrakt:	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. Trial Registration Number: ASPREE. NCT01038583. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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