{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T21:52:38Z","timestamp":1787953958463,"version":"build-2784847793"},"reference-count":17,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"15","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2024,8,6]]},"abstract":"<jats:sec xml:lang=\"en\">\n            <jats:title>Background<\/jats:title>\n            <jats:p xml:lang=\"en\">Aficamten, a novel cardiac myosin inhibitor, reversibly reduces cardiac hypercontractility in obstructive hypertrophic cardiomyopathy. We present a prespecified analysis of the pharmacokinetics, pharmacodynamics, and safety of aficamten in SEQUOIA\u2010HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Methods and Results<\/jats:title>\n            <jats:p xml:lang=\"en\">A total of 282 patients with obstructive hypertrophic cardiomyopathy were randomized 1:1 to daily aficamten (5\u201320\u2009mg) or placebo between February 1, 2022, and May 15, 2023. Aficamten dosing targeted the lowest effective dose for achieving site\u2010interpreted Valsalva left ventricular outflow tract gradient &lt;30\u2009mm\u2009Hg with left ventricular ejection fraction (LVEF) \u226550%. End points were evaluated during titration (day 1 to week 8), maintenance (weeks 8\u201324), and washout (weeks 24\u201328), and included major adverse cardiac events, new\u2010onset atrial fibrillation, implantable cardioverter\u2010defibrillator discharges, LVEF &lt;50%, and treatment\u2010emergent adverse events. At week 8, 3.6%, 12.9%, 35%, and 48.6% of patients achieved 5\u2010, 10\u2010, 15\u2010, and 20\u2010mg doses, respectively. Baseline characteristics were similar across groups. Aficamten concentration increased by dose and remained stable during maintenance. During the treatment period, LVEF decreased by \u22120.9% (95% CI, \u22121.3 to \u22120.6) per 100\u2009ng\/mL aficamten exposure. Seven (4.9%) patients taking aficamten underwent per\u2010protocol dose reduction for site\u2010interpreted LVEF &lt;50%. There were no treatment interruptions or heart failure worsening for LVEF &lt;50%. No major adverse cardiovascular events were associated with aficamten, and treatment\u2010emergent adverse events were similar between treatment groups, including atrial fibrillation.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p xml:lang=\"en\">A site\u2010based dosing algorithm targeting the lowest effective aficamten dose reduced left ventricular outflow tract gradient with a favorable safety profile throughout SEQUOIA\u2010HCM.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Registration<\/jats:title>\n            <jats:p xml:lang=\"en\">\n              URL:\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n              ; Unique Identifier: NCT05186818.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/jaha.124.035993","type":"journal-article","created":{"date-parts":[[2024,7,26]],"date-time":"2024-07-26T10:06:11Z","timestamp":1721988371000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":21,"title":["Dosing and Safety Profile of Aficamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy: Results From SEQUOIA\u2010HCM"],"prefix":"10.1161","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3208-470X","authenticated-orcid":false,"given":"Caroline J.","family":"Coats","sequence":"first","affiliation":[{"name":"University of Glasgow","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6390-6526","authenticated-orcid":false,"given":"Ahmad","family":"Masri","sequence":"additional","affiliation":[{"name":"Oregon Health and Science 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