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Ursodeoxycholic acid does not affect the clinical outcome of SARS‐CoV‐2 infection: A retrospective study of propensity score‐matched cohorts

Marrone et al., Liver International, doi:10.1111/liv.15736
Sep 2023  
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Mortality -7% Improvement Relative Risk UDCA for COVID-19  Marrone et al.  Prophylaxis Is prophylaxis with ursodeoxycholic acid beneficial for COVID-19? Retrospective 629 patients in Italy (March 2020 - December 2022) No significant difference in mortality c19early.org Marrone et al., Liver Int., September 2023 Favorsursodeoxycholic acid Favorscontrol 0 0.5 1 1.5 2+
PSM retrospective 629 hospitalized COVID-19 patients showing no significant difference in survival between 108 patients taking UDCA prior to infection compared to 521 matched controls not taking the drug. The lack of observed benefit in this retrospective inpatient cohort does not preclude potential protective effects of UDCA against infection or illness severe enough to require hospitalization.
risk of death, 7.0% higher, HR 1.07, p = 0.77, treatment 26 of 108 (24.1%), control 118 of 521 (22.6%), adjusted per study, multivariable, Cox proportional hazards.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Marrone et al., 21 Sep 2023, retrospective, Italy, peer-reviewed, 10 authors, study period 1 March, 2020 - 31 December, 2022.
This PaperUDCAAll
Ursodeoxycholic acid does not affect the clinical outcome of SARS‐CoV‐2 infection: A retrospective study of propensity score‐matched cohorts
Giuseppe Marrone, Marcello Covino, Giuseppe Merra, Andrea Piccioni, Annamaria Amodeo, Angela Novelli, Rita Murri, Maurizio Pompili, Antonio Gasbarrini, Francesco Franceschi
Liver International, doi:10.1111/liv.15736
Background: Ursodeoxycholic acid (UDCA) has been recently proposed as a modulator of angiotensin-converting enzyme 2 (ACE2) receptor expression, with potential effects on COVID-19. Aim and Study Design: We retrospectively evaluated the clinical course and outcome of subjects taking UDCA admitted to the hospital for COVID-19 compared with matched infected subjects. Differences regarding the severity and outcome of the disease between treated and non-treated subjects were assessed. The Kaplan-Meier survival analysis and log-rank test were used to evaluate the effect of UDCA on allcause intra-hospital mortality. Results: Among 6444 subjects with confirmed COVID-19 admitted to the emergency department (ED) from 1 March 2020 to 31 December 2022, 109 subjects were taking UDCA. After matching 629 subjects were included in the study: 521 in the no UDCA group and 108 in the UDCA group. In our matched cohort, 144 subjects (22.9%) died, 118 (22.6%) in the no-UDCA group and 26 (24.1%) in the UDCA group. The Kaplan-Meier analysis showed no significant difference in survival between groups. In univariate regression analysis, the presence of pneumonia, National Early Warning Score (NEWS) score, and Charlson Comorbidity Index (CCI) were significant independent predictors of death. At multivariate Cox regression analysis, age, NEWS, pneumonia and CCI index were confirmed significant independent predictors of death. UDCA treatment was not a predictor of survival both in univariate and multivariate regressions. Conclusions: UDCA treatment does not appear to have significant effects on the outcome of COVID-19. Specially designed prospective studies are needed to evaluate efficacy in preventing infection and severe disease. K E Y W O R D S COVID-19, SARS-CoV-2, UDCA Key points Treatment with ursodeoxycholic acid has no effect on the outcome of SARS-CoV-2 infection in hospitalized subjects. Age, presence of pneumonia, comorbidities and severity at onset are confirmed as predictors of unfavourable outcomes.
AUTH O R CO NTR I B UTI O N S Marcello Covino and Giuseppe Marrone were responsible for the conception and writing of the paper; Marcello Covino, Annamaria Amodeo and Giuseppe Marrone performed data collection, Marcello Covino and Giuseppe Marrone performed data analysis, Maurizio Pompili, Rita Murri, Angela Novelli, Andrea Piccioni and Giuseppe Merra reviewed the manuscript; Francesco Franceschi, Antonio Gasbarrini, Marcello Covino, Giuseppe Marrone performed final editing of the manuscript. All the authors approved the final version of the manuscript. CO N FLI C T O F I NTER E S T S TATEM ENT The authors do not have any disclosures to report. S U PP O RTI N G I N FO R M ATI O N Additional supporting information can be found online in the Supporting Information section at the end of this article. How to cite this article:
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Differences regarding the severity and outcome of the disease between treated and ' 'non‐treated subjects were assessed. The Kaplan–Meier survival analysis and log‐rank test were ' 'used to evaluate the effect of UDCA on all‐cause intra‐hospital ' 'mortality.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Among 6444 ' 'subjects with confirmed COVID‐19 admitted to the emergency department (ED) from 1 March 2020 ' 'to 31 December 2022, 109 subjects were taking UDCA. After matching 629 subjects were included ' 'in the study: 521 in the no UDCA group and 108 in the UDCA group. In our matched cohort, 144 ' 'subjects (22.9%) died, 118 (22.6%) in the no‐UDCA group and 26 (24.1%) in the UDCA group. The ' 'Kaplan–Meier analysis showed no significant difference in survival between groups. 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