Ursodeoxycholic acid and severe COVID-19 outcomes in people with liver disease: a cohort study using the OpenSAFELY platform
Ruth E Costello, Karen Mj Waller, Rachel Smith, George F Mells, Angel Ys Wong, Anna Schultze, Viyaasan Mahalingasivam, Emily Herrett, Bang Zheng, Liang-Yu Lin, Amir Mehrkar, Sebastian Cj Bacon, Ben Goldacre, Laurie A Tomlinson, John Tazare, Christopher T Rentsch
doi:10.1101/2023.12.11.23299191
Biological evidence suggests ursodeoxycholic acid (UDCA) -a common treatment of cholestatic liver disease -may prevent severe COVID-19 outcomes. With the approval of NHS England, we conducted a population-based cohort study using primary care records, linked to death registration data and hospital records through the OpenSAFELY-TPP platform. We estimated the hazard of COVID-19 hospitalisation or death between 1 March 2020 and 31 December 2022, comparing UDCA treatment to no UDCA treatment in a population with indication. Of 11,320 eligible individuals, 642 were hospitalised or died with COVID-19 during follow-up, 402 (63%) events among UDCA users. After confounder adjustment, UDCA was associated with a 21% (95% CI 7%-33%) relative reduction in the hazard of COVID-19 hospitalisation or death, consistent with an absolute risk reduction of 1.3% (95% CI 1.0%-1.6%). Our findings support calls for clinical trials investigating UDCA as a preventative measure for severe COVID-19 outcomes. .
Conflicts of interest BG has received research funding from the Bennett Foundation, the Laura and John Arnold Foundation, the NHS National Institute for Health Research (NIHR), the NIHR School of Primary Care Research, NHS England, the NIHR Oxford Biomedical Research Centre, the Mohn-Westlake Foundation, NIHR Applied Research Collaboration Oxford and Thames Valley, the Wellcome Trust, the Good Thinking Foundation, Health Data Research UK, the Health Foundation, the World Health Organisation, UKRI MRC, Asthma UK, the British Lung Foundation, and the Longitudinal Health and Wellbeing strand of the National Core Studies programme; he is a Non-Executive Director at NHS Digital; he also receives personal income from speaking and writing for lay audiences on the misuse of science. BMK is also employed by NHS England working on medicines policy and clinical lead for primary care medicines data. AM is a member of RCGP health informatics group and the NHS Digital GP data Professional Advisory Group, and received consulting fee from Induction Healthcare. LAT has received research funding from MRC, Wellcome, NIHR and GSK, consulted for Bayer in relation to an observational study of chronic kidney disease (unpaid), and is a member of 4 non-industry funded (NIHR/MRC) trial advisory committees (unpaid) and MHRA Expert advisory group (Women's Health). REC has shares in AstraZeneca. VM received a grant from NIHR. AS is employed by LSHTM on a fellowship sponsored by GSK. JT received an..
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'abstract': '<jats:p>Biological evidence suggests ursodeoxycholic acid (UDCA) - a common treatment of '
'cholestatic liver disease - may prevent severe COVID-19 outcomes. With the approval of NHS '
'England, we conducted a population-based cohort study using primary care records, linked to '
'death registration data and hospital records through the OpenSAFELY-TPP platform. We '
'estimated the hazard of COVID-19 hospitalisation or death between 1 March 2020 and 31 '
'December 2022, comparing UDCA treatment to no UDCA treatment in a population with indication. '
'Of 11,320 eligible individuals, 642 were hospitalised or died with COVID-19 during follow-up, '
'402 (63%) events among UDCA users. After confounder adjustment, UDCA was associated with a '
'21% (95% CI 7%-33%) relative reduction in the hazard of COVID-19 hospitalisation or death, '
'consistent with an absolute risk reduction of 1.3% (95% CI 1.0%-1.6%). Our findings support '
'calls for clinical trials investigating UDCA as a preventative measure for severe COVID-19 '
'outcomes.</jats:p>',
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