{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T14:25:59Z","timestamp":1791728759331,"version":"4.3.4"},"reference-count":33,"publisher":"American Medical Association (AMA)","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Cardiol"],"published-print":{"date-parts":[[2026,1,1]]},"abstract":"\n Importance<\/jats:title>\n Transthyretin amyloid cardiomyopathy (ATTR-CM), a progressive disease caused by misfolded transthyretin (TTR), occurs as wild-type (ATTRwt-CM) or variant (ATTRv-CM) forms. p.Val142Ile is the most common variant in the US, linked to rapid progression and increased mortality. Acoramidis achieves near-complete (\u226590%) TTR stabilization and showed clinical benefit in the 30-month ATTRibute-CM trial and through month 42 in the ongoing open-label extension (OLE).<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the efficacy of acoramidis in ATTRwt-CM, ATTRv-CM, and variant subgroups (p.Val142Ile and non-p.Val142Ile).<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This international, multicenter, phase 3, randomized placebo-controlled study took place from April 2019 to May 2023 with ongoing OLE (month 42). ATTRibute-CM enrolled 632 participants with ATTR-CM; 611 of 632 were included in the modified intention-to-treat (mITT) population. There were 380 participants who continued into the OLE. These data were analyzed from January 2025 to July 2025.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Oral acoramidis, 712 mg, or placebo twice daily for 30 months, followed by 12 months of open-label treatment.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n All-cause mortality (ACM), cardiovascular-related hospitalizations (CVH), serum TTR, 6-minute walk distance, Kansas City Cardiomyopathy Questionnaire Overall Summary score, and N-terminal pro B-type natriuretic peptide in participants with ATTRwt-CM and ATTRv-CM. Post-hoc analyses were conducted in variant subgroups, including p.Val142Ile.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Overall, 552 participants with wild-type ATTR-CM (mean [SD] age, 78 [6.3] years; 92.0% male and 8.0% female) and 59 participants with variant ATTR-CM (mean [SD] age, 73 [7.7] years; 77.3% male and 22.7% female) were randomized (mITT population), including 35 with p.Val142Ile. Consistent efficacy was observed in wild-type and variant subgroups for ACM\/CVH through month 30 and ACM through month 42. At month 30, acoramidis reduced the risk of ACM\/first CVH vs placebo by 31% in ATTRwt-CM (hazard ratio [HR], 0.69; 95% CI, 0.52-0.90;\n P<\/jats:italic>\n \u2009=\u2009.007) and by 59% in ATTRv-CM (HR, 0.41; 95% CI, 0.21-0.81;\n P<\/jats:italic>\n \u2009=\u2009.01). ACM was reduced through month 42 with HRs of 0.70 (95% CI, 0.50-0.98;\n P<\/jats:italic>\n \u2009=\u2009.04) and 0.41 (95% CI, 0.19-0.93;\n P<\/jats:italic>\n \u2009=\u2009.03) in the ATTRwt-CM and ATTRv-CM groups, respectively. Consistent treatment benefit was observed in participants with ATTRwt-CM and ATTRv-CM for secondary end points. Within variant subgroups (p.Val142Ile vs non-p.Val142Ile), consistent treatment benefits were observed for ACM\/CVH through month 30 and ACM through month 42.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n The beneficial effect of acoramidis was observed consistently in ATTRwt-CM and ATTRv-CM groups. These hypothesis-generating results indicate that further studies are warranted to better characterize the therapeutic benefit of acoramidis in variant subgroups.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifiers:\n NCT03860935<\/jats:ext-link>\n ;\n NCT04988386<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamacardio.2025.4477","type":"journal-article","created":{"date-parts":[[2025,11,8]],"date-time":"2025-11-08T16:30:17Z","timestamp":1762619417000},"page":"57","source":"Crossref","is-referenced-by-count":12,"title":["Efficacy of Acoramidis in Wild-Type and Variant Transthyretin Amyloid Cardiomyopathy"],"prefix":"10.1001","volume":"11","author":[{"given":"Kevin M.","family":"Alexander","sequence":"first","affiliation":[{"name":"Stanford Amyloid Center, Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margot 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Press release: Acoramidis approved to treat wild-type or variant transthyretin amyloidosis in adults with cardiomyopathy. 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