{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T07:00:38Z","timestamp":1785135638807,"version":"3.55.0"},"reference-count":20,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2026,7,26]],"date-time":"2026-07-26T00:00:00Z","timestamp":1785024000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Cardiovasc. Dev. Dis.","JCDD"],"abstract":"<jats:p>Acoramidis is a novel transthyretin stabilizer recently approved for the treatment of transthyretin amyloid cardiomyopathy. Although clinical trials showed that the drug was generally safe, comprehensive real-world safety data after its approval remain limited. This study characterizes the real-world safety profile of acoramidis using the FDA Adverse Event Reporting System (FAERS) database. The database was queried for adverse events associated with acoramidis as the primary drug suspect from 1 January 2022 through 31 December 2025. Following deduplication and removal of confounding adverse events that could have stemmed from the underlying amyloidosis, a dual-statistical framework was applied. Frequentist disproportionality analysis was followed by Bayesian shrinkage using a Bayesian Confidence Propagation Neural Network to isolate statistically robust safety signals. Frequentist disproportionality analysis of 290 unique cases identified 25 safety signals. Subsequent Bayesian refinement isolated nine signals that met both frequentist and Bayesian criteria. The dual Bayesian and frequentist approaches identified signals of renal stress and gastrointestinal distress. Neuromuscular and systemic signals such as fatigue and dizziness met frequentist thresholds but did not meet the Bayesian threshold. This study\u2019s findings reflect the previously reported gastrointestinal distress and disproportionate laboratory shifts in renal function. This study\u2019s real-world post-marketing surveillance of acoramidis reinforces the safety data that was established through the clinical trial, ATTRibute-CM.<\/jats:p>","DOI":"10.3390\/jcdd13080349","type":"journal-article","created":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T05:49:27Z","timestamp":1785131367000},"page":"349","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-World Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy: A Pharmacovigilance Study"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-8260-1463","authenticated-orcid":false,"given":"Gregory W.","family":"Chai","sequence":"first","affiliation":[{"name":"Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 3K9, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quynh","family":"Phi","sequence":"additional","affiliation":[{"name":"Schulich School of Medicine and Dentistry, University of Western Ontario, London, ON N6A 5C1, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diego Herman","family":"Delgado","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Peter Munk Cardiac Centre, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON M5G 2N2, Canada"},{"name":"Toronto General Hospital Research Institute, University Health Network, Toronto, ON M5G 2C4, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,26]]},"reference":[{"key":"ref_1","unstructured":"Shams, P., and Ahmed, I. (2025). Cardiac Amyloidosis. StatPearls, StatPearls Publishing."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1007","DOI":"10.1056\/NEJMoa1805689","article-title":"Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy","volume":"379","author":"Maurer","year":"2018","journal-title":"N. Engl. J. Med."},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"Tomasoni, D., Bonfioli, G.B., Aimo, A., Adamo, M., Canepa, M., Inciardi, R.M., Lombardi, C.M., Nardi, M., Pagnesi, M., and Riccardi, M. (2023). Treating Amyloid Transthyretin Cardiomyopathy: Lessons Learned from Clinical Trials. Front. Cardiovasc. Med., 10.","DOI":"10.3389\/fcvm.2023.1154594"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"132","DOI":"10.1056\/NEJMoa2305434","article-title":"Efficacy and Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy","volume":"390","author":"Gillmore","year":"2024","journal-title":"N. Engl. J. 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PLoS ONE, 20.","DOI":"10.1371\/journal.pone.0330769"},{"key":"ref_8","first-page":"20110544","article-title":"Joining Forces of Bayesian and Frequentist Methodology: A Study for Inference in the Presence of Non-Identifiability","volume":"371","author":"Raue","year":"2013","journal-title":"Philos. Trans. A Math. Phys. Eng. Sci."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"483","DOI":"10.1002\/pds.677","article-title":"Use of Proportional Reporting Ratios (PRRs) for Signal Generation from Spontaneous Adverse Drug Reaction Reports","volume":"10","author":"Evans","year":"2001","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"315","DOI":"10.1007\/s002280050466","article-title":"A Bayesian Neural Network Method for Adverse Drug Reaction Signal Generation","volume":"54","author":"Bate","year":"1998","journal-title":"Eur. J. Clin. Pharmacol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"3740","DOI":"10.1002\/sim.2473","article-title":"Extending the Methods Used to Screen the WHO Drug Safety Database towards Analysis of Complex Associations and Improved Accuracy for Rare Events","volume":"25","author":"Bate","year":"2006","journal-title":"Stat. Med."},{"key":"ref_12","unstructured":"BridgeBio Pharma, Inc (2024). ATTRUBYTM (Acoramidis) Tablets, for Oral Administration, Initial U.S. Approval: 2024, U.S. Food and Drug Administration."},{"key":"ref_13","unstructured":"Shams, P., Malik, A., and Chhabra, L. (2026). Heart Failure (Congestive Heart Failure). StatPearls, StatPearls Publishing."},{"key":"ref_14","unstructured":"KDIGO Work Group (2024). Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int., 105, S117\u2013S314."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"204","DOI":"10.1097\/FJC.0000000000001726","article-title":"Differential Binding Affinities and Kinetics of Transthyretin Stabilizers","volume":"86","author":"Ji","year":"2025","journal-title":"J. Cardiovasc. Pharmacol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1076","DOI":"10.1016\/j.jacc.2022.11.022","article-title":"2023 ACC Expert Consensus Decision Pathway on Comprehensive Multidisciplinary Care for the Patient with Cardiac Amyloidosis","volume":"81","author":"Kittleson","year":"2023","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"35028","DOI":"10.1038\/s41598-025-21745-5","article-title":"Polyneuropathy in Hereditary and Wildtype Transthyretin Amyloidosis, Comparison of Key Clinical Features and Red Flags","volume":"15","author":"Siemer","year":"2025","journal-title":"Sci. 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