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    Long-Term Survival With Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy

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    Author
    Elliott, Perry
    Drachman, Brian M.
    Gottlieb, Stephen S.
    Hoffman, James E.
    Hummel, Scott L.
    Lenihan, Daniel J.
    Ebede, Ben
    Gundapaneni, Balarama
    Li, Benjamin
    Sultan, Marla B.
    Shah, Sanjiv J.
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    Date
    2021-12-20
    Journal
    Circulation: Heart Failure
    Publisher
    Ovid Technologies (Wolters Kluwer Health)
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1161/CIRCHEARTFAILURE.120.008193
    Abstract
    Background: 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). Methods: 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. Results: 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, 0.44-0.79]; P<0.001). Mortality was also reduced in the continuous tafamidis (versus placebo to tafamidis) subgroups of: variant transthyretin amyloidosis (0.57 [0.33-0.99]; P=0.05) and wild-type transthyretin amyloidosis (0.61 [0.43-0.87]; P=0.006); and baseline New York Heart Association class I and II (0.56 [0.38-0.82]; P=0.003) and class III (0.65 [0.41-1.01]; P=0.06). Conclusions: 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. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01994889 and NCT02791230.
    Keyword
    amyloid
    cardiomyopathies
    heart failure
    mutation
    phenotype
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/17618
    ae974a485f413a2113503eed53cd6c53
    10.1161/circheartfailure.120.008193
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