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    About

    About ATTR-CM

    About ATTR-CM

    Symptom presentation

    Clinical clues

    Diagnosing
    ​​​​​​​ATTR-CM

    Transthyretin amyloid cardiomyopathy (ATTR-CM)—a disease that may be present in patients with heart failure1-3

    Transthyretin amyloid cardiomyopathy—a fatal, underdiagnosed cardiomyopathy caused by aggregated misfolded proteins, called amyloid fibrils, that accumulate in the myocardium

    • Subtypes of ATTR-CM1,2:
      • Wild-type ATTR (wtATTR)
      • Hereditary ATTR (hATTR)
        • In the United States, Val122lle and Thr60Ala are the most common mutations that typically manifest as cardiomyopathy symptoms4
    • Transthyretin amyloid cardiomyopathy is frequently misdiagnosed, and delayed diagnosis can lead to significant clinical consequences for patients4
    • Patients present with symptoms of heart failure and may also present with other manifestations, such as atrial fibrillation and carpal tunnel syndrome, often bilateral3,4
    • Once diagnosed, untreated patients have a median survival of ~2 to 3.5 years4

    Among older patients with HFpEF, approximately 7%-13% had wild-type ATTR-CM5,6

    Study descriptions5,6

    Wild-type transthyretin amyloidosis as a cause of heart failure with preserved ejection fraction

    The study by González-López et al was a prospective, cross-sectional, single-center study at a tertiary university hospital in Madrid, Spain, to determine the prevalence of wtATTR-CM among elderly patients admitted to the hospital due to HFpEF. The study prospectively screened all patients ≥60 years of age admitted for HFpEF. The study population included 120 HFpEF patients (59% women, mean age: 82±8 years) with LV ejection fraction ≥50% and LV hypertrophy ≥12 mm. All eligible patients were offered a DPD scintigraphy scan to confirm ATTR-CM.

    Endomyocardial biopsy characterization of heart failure with preserved ejection fraction and prevalence of cardiac amyloidosis

    The study by Hahn et al was a prospective analysis in 108 patients (61% women, age range: 57-74 years) seen at Johns Hopkins Center for HFpEF who underwent endomyocardial biopsy to evaluate mycardial tissue histopathology.

    LV=left ventricular.

    HFpEF=heart failure with preserved ejection fraction.​​​​​​​

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    References:
    1. Nativi-Nicolau J, Maurer MS. Amyloidosis cardiomyopathy: update in the diagnosis and treatment of the most common types. Curr Opin Cardiol. 2018;33(5):571-579.
    2. Sipe JD, Benson MD, Buxbaum JN, et al. Amyloid fibril proteins and amyloidosis: chemical identification and clinical classification International Society of Amyloidosis 2016 Nomenclature Guidelines. Amyloid. 2016;23(4):209-213.
    3. Narotsky DL, Castano A, Weinsaft JW, Bokhari S, Maurer MS. Wild-type transthyretin cardiac amyloidosis: novel insights from advanced imaging. Can J Cardiol. 2016;32(9):1166.e1-1166.e10.
    4. Maurer MS, Elliott P, Comenzo R, Semigran M, Rapezzi C. Addressing common questions encountered in the diagnosis and management of cardiac amyloidosis. Circulation. 2017;135(14):1357-1377.
    5. González-López E, Gallego-Delgado M, Guzzo-Merello G, et al. Wild-type transthyretin amyloidosis as a cause of heart failure with preserved ejection fraction. Eur Heart J. 2015;36(38):2585-2594.
    6. Hahn VS, Yanek LR, Vaishnav J, et al. Endomyocardial biopsy characterization of heart failure with preserved ejection fraction and prevalence of cardiac amyloidosis. JACC Heart Fail. 2020;8(9):712-724. doi:10.1016/j.jchf.2020.04.007

    About

    • About ATTR-CM
    • MOD/MOA
    • Study Design

    ATTR-ACT—a phase 3 pivotal study in patients with ATTR-CM

    Read the study design


    VYNDAMAX® AND VYNDAQEL® are registered trademarks of Pfizer Inc.

    Adverse Reactions

    In studies in patients with ATTR-CM, the frequency of adverse events in patients treated with VYNDAQEL® (tafamidis meglumine) was similar to placebo.

    Specific Populations

    Pregnancy: Based on findings from animal studies, VYNDAQEL and VYNDAMAX may cause fetal harm when administered to a pregnant woman.

    Lactation: There are no available data on the presence of tafamidis in human milk, the effect on the breastfed infant, or the effect on milk production. Tafamidis is present in rat milk. When a drug is present in animal milk, it is likely the drug will be present in human milk. Breastfeeding is not recommended during treatment with VYNDAQEL and VYNDAMAX.

    VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
    ​​​​​​​
    Please see Full Prescribing Information including Patient Information.

      INDICATION AND LIMITATIONS OF USE

      VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
      ​​​​​​​
      Please see Full Prescribing Information including Patient Information.