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Sodium-based paracetamol: impact on blood pressure, cardiovascular events, and all-cause mortality

Lookup NU author(s): Dr Dexter CanoyORCiD

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.BACKGROUND AND AIMS: Effervescent formulations of paracetamol containing sodium bicarbonate have been reported to associate with increased blood pressure and a higher risk of cardiovascular diseases and all-cause mortality. Given the major implications of these findings, the reported associations were re-examined. METHODS: Using linked electronic health records data, a cohort of 475 442 UK individuals with at least one prescription of paracetamol, aged between 60 and 90 years, was identified. Outcomes in patients taking sodium-based paracetamol were compared with those taking non-sodium-based formulations of the same. Using a deep learning approach, associations with systolic blood pressure (SBP), major cardiovascular events (myocardial infarction, heart failure, and stroke), and all-cause mortality within 1 year after baseline were investigated. RESULTS: A total of 460 980 and 14 462 patients were identified for the non-sodium-based and sodium-based paracetamol exposure groups, respectively (mean age: 74 years; 64% women). Analysis revealed no difference in SBP [mean difference -0.04 mmHg (95% confidence interval -0.51, 0.43)] and no association with major cardiovascular events [relative risk (RR) 1.03 (0.91, 1.16)]. Sodium-based paracetamol showed a positive association with all-cause mortality [RR 1.46 (1.40, 1.52)]. However, after further accounting of other sources of residual confounding, the observed association attenuated towards the null [RR 1.08 (1.01, 1.16)]. Exploratory analyses revealed dysphagia and related conditions as major sources of uncontrolled confounding by indication for this association. CONCLUSIONS: This study does not support previous suggestions of increased SBP and an elevated risk of cardiovascular events from short-term use of sodium bicarbonate paracetamol in routine clinical practice.


Publication metadata

Author(s): Rao S, Nazarzadeh M, Canoy D, Li Y, Huang J, Mamouei M, Salimi-Khorshidi G, Schutte AE, Neal B, Smith GD, Rahimi K

Publication type: Article

Publication status: Published

Journal: European Heart Journal

Year: 2023

Volume: 44

Issue: 42

Pages: 4448-4457

Print publication date: 07/11/2023

Online publication date: 23/08/2023

Acceptance date: 09/08/2023

Date deposited: 28/11/2023

ISSN (print): 0195-668X

ISSN (electronic): 1522-9645

Publisher: Oxford University Press

URL: https://doi.org/10.1093/eurheartj/ehad535

DOI: 10.1093/eurheartj/ehad535

Data Access Statement: Regarding accessibility of Clinical Practice Research Datalink (CPRD) data, https://www.cprd.com/primary-care explains: ‘Access to data from CPRD is subject to a full licence agreement containing detailed terms and conditions of use. Patient level datasets can be extracted for researchers against specific study specifications, following protocol approval from the Independent Scientific Advisory Committee (ISAC)’. Thus, restrictions apply to the availability of these data, which were used under licence for the current study, and so are not publicly available. More details of the data and data sharing are found on the CPRD website (https://www.cprd.com). The Targeted-BEHRT source code can be found on the Deep Medicine research GitHub site (https://github.com/deepmedicine).

PubMed id: 37611115


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Funding

Funder referenceFunder name
British Heart Foundation
ES/P011055/1
FS/19/36/34346/BHF
FS/PhD/21/29110
Global Challenges Research Fund
MC_UU_00011/1
Medical Research Council
Medical Research Future Fund of Australia (MRFF)
National Health and Medical Research Council of Australia (NHMRC)
National Institute for Health and Care Research (NIHR)
NIHR203982
NIHR Bristol Biomedical Research Centre
Novo Nordisk
Oxford Martin School (OMS)
University of Oxford

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