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About ATTR-CM

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  • Prescribing Information
  • Patient Information
  • Patient Site

  • About ATTR-CM

    Disease overview

    Symptom presentation

    Clinical clues

    Diagnosing
    ​​​​​​​ATTR-CM

    Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive disease that is underdiagnosed in patients with heart failure (HF)1

    ATTR-CM is caused by the aggregation of transthyretin (TTR) amyloid fibrils in the myocardium.1

    • Two subtypes:
      • Wild-type ATTR-CM (wtATTR-CM)
      • Hereditary ATTR-CM (hATTR-CM)*

    Rare but there

    ATTR-CM is one of the most common types of cardiac amyloidosis and it may be the cause of HF in some of your current patients.1,2

    Studies have shown:

    ~7%-13% of older patients with HFpEF had wtATTR deposits in their heart3,4†
    ~3%-4% of African Americans have V122I, a prevalent TTR mutation associated with hATTR-CM in the United States, although not all individuals with V122I mutation develop symptoms1,2‡
    Aortic stenosis: In a study of patients undergoing TAVR for severe aortic stenosis, 16% had ATTR-CM

       *In the United States, Val122Ile and Thr60Ala are the most common mutations that typically manifest as cardiomyopathy symptoms.2

       †Study designs: 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. The study by Hahn et al was a prospective analysis in 108 patients (61% women, age range: 57-74 years) seen at the Johns Hopkins Center for HFpEF who underwent endomyocardial biopsy to evaluate myocardial tissue histopathology.3,4​​​​​​​

       ‡Although not all individuals with the V122I mutation develop symptoms.1​​​​​​​

    ​​​​​​​  §A study of 151 prospectively recruited patients with severe calcific aortic stenosis undergoing TAVR at Columbia University Medical Center to determine prevalence and phenotype of ATTR-CM non-invasively.5
    ​​​​​​​

      HFpEF=heart failure with preserved ejection fraction; LV=left ventricular; TAVR=transcatheter aortic valve replacement.

    Next: Learn how ATTR-CM symptoms present in HF patients

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    Continue to Symptom presentation

    ** This is an optional area where footnotes can live.


    References:
    1. Witteles RM, Bokhari S, Damy T, et al. Screening for transthyretin amyloid cardiomyopathy in everyday practice. JACC Heart Fail. 2019;7(8):709-716.
    2. Maurer MS, Bokhari S, Damy T, et al. Expert consensus recommendations for the suspicion and diagnosis of transthyretin cardiac amyloidosis. Circ Heart Fail. 2019;12(9):e006075. 
    3. 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.
    4. 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.
    5. Castaño A, Narotsky DL, Hamid N, et al. Unveiling transthyretin cardiac amyloidosis and its predictors among elderly patients with severe aortic stenosis undergoing transcatheter aortic valve replacement. Eur Heart J. 2017;38(38):2879-2887.

    About

    • About ATTR-CM
    • MOD/MOA
    • 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.

              Please see full Prescribing Information.

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