Real-World Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy: A Pharmacovigilance Study.
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アブストラクト 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's findings reflect the previously reported gastrointestinal distress and disproportionate laboratory shifts in renal function. This study's real-world post-marketing surveillance of acoramidis reinforces the safety data that was established through the clinical trial, ATTRibute-CM. ジャーナル名 Journal of cardiovascular development and disease Pubmed追加日 2026/8/26 投稿者 Chai, Gregory W; Phi, Quynh; Delgado, Diego Herman 組織名 Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 3K9, Canada.;Schulich School of Medicine and Dentistry, University of Western Ontario, London,;ON N6A 5C1, Canada.;Division of Cardiology, Peter Munk Cardiac Centre, Toronto General Hospital,;University Health Network, University of Toronto, Toronto, ON M5G 2N2, Canada.;Toronto General Hospital Research Institute, University Health Network, Toronto,;ON M5G 2C4, Canada. Pubmed リンク https://www.ncbi.nlm.nih.gov/pubmed/42645820/ -
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