{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,2]],"date-time":"2026-11-02T20:26:22Z","timestamp":1793651182697,"version":"4.5.1"},"reference-count":20,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","license":[{"start":{"date-parts":[[2022,1,1]],"date-time":"2022-01-01T00:00:00Z","timestamp":1640995200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Heart Failure"],"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Tafamidis is approved in many countries for the treatment of transthyretin amyloid cardiomyopathy. This study reports data on the long-term efficacy of tafamidis from an ongoing long-term extension (LTE) to the pivotal ATTR-ACT (Tafamidis in Transthyretin Cardiomyopathy Clinical Trial).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Patients with transthyretin amyloid cardiomyopathy who completed ATTR-ACT could enroll in an LTE, continuing with the same tafamidis dose or, if previously treated with placebo, randomized (2:1) to tafamidis meglumine 80 or 20 mg. All patients in the LTE transitioned to tafamidis free acid 61 mg (bioequivalent to tafamidis meglumine 80 mg) following a protocol amendment. In this interim analysis, all-cause mortality was assessed in patients treated with tafamidis meglumine 80 mg in ATTR-ACT continuing in the LTE, compared with those receiving placebo in ATTR-ACT transitioning to tafamidis in the LTE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Median follow-up was 58.5 months in the continuous tafamidis group (n=176) and 57.1 months in the placebo to tafamidis group (n=177). There were 79 (44.9%) deaths with continuous tafamidis and 111 (62.7%) with placebo to tafamidis (hazard ratio, 0.59 [95% CI, 0.44\u20130.79];\n                      <jats:italic>P<\/jats:italic>\n                      &lt;0.001). Mortality was also reduced in the continuous tafamidis (versus placebo to tafamidis) subgroups of: variant transthyretin amyloidosis (0.57 [0.33\u20130.99];\n                      <jats:italic>P<\/jats:italic>\n                      =0.05) and wild-type transthyretin amyloidosis (0.61 [0.43\u20130.87];\n                      <jats:italic>P<\/jats:italic>\n                      =0.006); and baseline New York Heart Association class I and II (0.56 [0.38\u20130.82];\n                      <jats:italic>P<\/jats:italic>\n                      =0.003) and class III (0.65 [0.41\u20131.01];\n                      <jats:italic>P<\/jats:italic>\n                      =0.06).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>In the LTE, patients initially treated with tafamidis in ATTR-ACT had substantially better survival than those first treated with placebo, highlighting the importance of early diagnosis and treatment in transthyretin amyloid cardiomyopathy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Registration:<\/jats:title>\n                    <jats:p>\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: NCT01994889 and NCT02791230.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circheartfailure.120.008193","type":"journal-article","created":{"date-parts":[[2021,12,20]],"date-time":"2021-12-20T05:00:22Z","timestamp":1639976422000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":178,"title":["Long-Term Survival With Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy"],"prefix":"10.1161","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3383-3984","authenticated-orcid":true,"given":"Perry","family":"Elliott","sequence":"first","affiliation":[{"name":"University College London, United Kingdom (P.E.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian M.","family":"Drachman","sequence":"additional","affiliation":[{"name":"Penn Presbyterian Medical Center, University of Pennsylvania Health System, Philadelphia (B.M.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8922-1840","authenticated-orcid":true,"given":"Stephen S.","family":"Gottlieb","sequence":"additional","affiliation":[{"name":"University of Maryland School of Medicine, Baltimore (S.S.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James E.","family":"Hoffman","sequence":"additional","affiliation":[{"name":"University of Miami, FL (J.E.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0924-3135","authenticated-orcid":true,"given":"Scott L.","family":"Hummel","sequence":"additional","affiliation":[{"name":"University of Michigan and Ann Arbor Veterans Affairs Health System (S.L.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9458-0154","authenticated-orcid":true,"given":"Daniel J.","family":"Lenihan","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine, St. Louis, MO (D.J.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ben","family":"Ebede","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Collegeville, PA (B.E.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Balarama","family":"Gundapaneni","sequence":"additional","affiliation":[{"name":"Pfizer Inc, Groton, CT (B.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Li","sequence":"additional","affiliation":[{"name":"Pfizer Inc, New York, NY (B.L., M.B.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marla B.","family":"Sultan","sequence":"additional","affiliation":[{"name":"Pfizer Inc, New York, NY (B.L., M.B.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5655-8201","authenticated-orcid":true,"given":"Sanjiv J.","family":"Shah","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (S.J.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1038\/nrcardio.2010.67"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2019.04.003"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(11)70246-0"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.3109\/13506129.2015.1051219"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1404852"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCHEARTFAILURE.115.002558"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehx589"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2012.04.015"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.2217\/ahe.13.10"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2016.06.033"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.1121005109"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40120-015-0031-3"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1805689"},{"key":"e_1_3_2_15_2","unstructured":"VYNDAQEL and VYNDAMAX Highlights of Prescribing Information. https:\/\/www.fda.gov\/media\/126283\/download. 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