Statins Combined with Anticoagulants on Heart Failure in Atrial Fibrillation Patients: A Disproportionality Analysis Based on the FAERS Database

Statins Combined with Anticoagulants on Heart Failure in Atrial Fibrillation Patients: A Disproportionality Analysis Based on the FAERS Database | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Statins Combined with Anticoagulants on Heart Failure in Atrial Fibrillation Patients: A Disproportionality Analysis Based on the FAERS Database Bo Wu, Pengfei Gao This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7496458/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Statins and anticoagulants are widely used in atrial fibrillation (AF) patients, but their combined effects on heart failure remain unclear. This study aims to investigate the impact of statins combined with anticoagulants on heart failure in AF patients. A disproportionality analysis was conducted on relevant data from the FAERS database spanning from Q1 2004 to Q2 2024. Seven statins and five direct oral anticoagulants (DOACs) were included. Adverse events were identified using MedDRA 25.0, with Reporting Odds Ratio (ROR) used for signal detection and Ω shrinkage for drug interaction detection. Sensitivity analysis excluded potential confounders. Compared with AF patients not receiving statins, statin users showed a higher reporting risk of heart failure (ROR 1.60, 95% CI 1.51–1.69), with pitavastatin demonstrating the strongest association (ROR 2.47, 95% CI 1.78–3.45). However, in statin users, the addition of anticoagulants did not increase the risk of heart failure (ROR 0.60 [95% CI 0.55-0.66]). This study suggests that while the combination of statins and anticoagulants may increase the risk of heart failure in AF patients, the risk varies among different statins. Health sciences/Cardiology Health sciences/Diseases Biological sciences/Drug discovery Health sciences/Medical research Health sciences/Risk factors FAERS disproportionality analysis anticoagulants statins drug combinations Full Text Additional Declarations No competing interests reported. Supplementary Files SupplementaryDocuments.pdf Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7496458","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":534001239,"identity":"1fcef11e-e5c8-4b3f-bfde-aa454cedbb04","order_by":0,"name":"Bo Wu","email":"","orcid":"","institution":"The Second People's Hospital of Hunan Province (Hunan Brain 8 Hospital)","correspondingAuthor":false,"prefix":"","firstName":"Bo","middleName":"","lastName":"Wu","suffix":""},{"id":534001240,"identity":"46285f77-2eee-43e6-bc3d-4c972e9f2aef","order_by":1,"name":"Pengfei 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This study aims to investigate the impact of statins combined with anticoagulants on heart failure in AF patients. A disproportionality analysis was conducted on relevant data from the FAERS database spanning from Q1 2004 to Q2 2024. Seven statins and five direct oral anticoagulants (DOACs) were included. Adverse events were identified using MedDRA 25.0, with Reporting Odds Ratio (ROR) used for signal detection and Ω shrinkage for drug interaction detection. Sensitivity analysis excluded potential confounders. Compared with AF patients not receiving statins, statin users showed a higher reporting risk of heart failure (ROR 1.60, 95% CI 1.51–1.69), with pitavastatin demonstrating the strongest association (ROR 2.47, 95% CI 1.78–3.45). However, in statin users, the addition of anticoagulants did not increase the risk of heart failure (ROR 0.60 [95% CI 0.55-0.66]). 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