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About VYNDAQEL

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Study DesignEfficacySafety ProfileDosingSupporting Resources Supporting ResourcesNICE Final Draft GuidanceAvailability in Scotland2021 ESC Heart Failure GuidelinesRisk Minimisation MaterialContact usMaterials

Click here for VYNDAQEL®▼ (tafamidis) Prescribing Information. 

The study of tafamidis in ATTR-CMThe Transthyretin Amyloidosis
Cardiomyopathy Clinical Trial (ATTR-ACT)

ATTR-ACT was a phase 3, multicentre, international, parallel-design, placebo-controlled, double-blind, randomised trial in 441 patients with wild-type or hereditary ATTR-CM1 

The analysis compared the results of a pooled tafamidis (20 mg and 80 mg as meglumine) treatment group (n=264) with the placebo group (n=177)1

ATTR-ACT study design1

In the ATTR-ACT trial, patients were randomly assigned to receive 80 mg of tafamidis meglumine, 20 mg of tafamidis meglumine, or placebo once daily.

VYNDAQEL 61 mg (tafamidis) corresponds to 80 mg tafamidis meglumine. Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis.2 Tafamidis meglumine 20 mg is not licensed in ATTR-CM.

View the ATTR-ACT study publication for study details and results

View the ATTR-ACT study publicationLoading
Inclusion and exclusion criteriaInclusion criteria1
  • Patients between 18 and 90 years of age
  • Confirmation of ATTR-CM, wild type or hereditary
  • Echocardiography with an end-diastolic interventricular septal wall thickness >12 mm
  • History of heart failure with at least 1 prior hospitalisation for heart failure, or clinical evidence of heart failure (without hospitalisation)
  • NT-proBNP level ≥600 pg/mL
  • 6MWT >100 m
Exclusion criteria1 
  • Heart failure unrelated to ATTR-CM
  • NYHA class IV heart failure
  • Light-chain amyloidosis
  • History of liver or heart transplantation
  • Implanted cardiac mechanical assist device
  • Pregnancy or breastfeeding
  • Previous VYNDAQEL treatment
  • eGFR<25 mL/min/1.73 m2
  • Liver transaminase levels >2x the upper limit of normal
  • mBMI <600§
  • Concurrent treatment with NSAIDS, tauroursodeoxycholate, doxycycline, calcium-channel blockers, or digitalis
‡Manifested in signs or symptoms of volume overload or elevated intracardiac pressures requiring treatment with a diuretic for improvement.1
§Modified BMI is calculated as the serum albumin level in grams per litre multiplied by the conventional BMI (the weight in kilograms divided by the square of the height in metres).1
¶Select NSAIDs were permitted (e.g., aspirin, ibuprofen, naproxen).
Overall baseline characteristics in ATTR-ACT were balanced across treatment arms1 Primary analysis used the Finkelstein–Schoenfeld method1

Frequency of CV-related hospitalisations only used to compare patients who cannot be differentiated based on all-cause mortality. Consequently, only patients alive at Month 30 were assessed in the next analysis. It should be noted that the hierarchical analysis only proceeds to the next endpoint if the previous one reaches significance.1

†Primary analysis: hierarchical assessment of all-cause mortality, followed by frequency of cardiovascular-related hospitalisations over the course of 30 months, applying the Finkelstein–Schoenfeld statistical method. The analysis compared the results of a pooled tafamidis (20 mg and 80 mg as meglumine) treatment group (n=264) with the placebo group (n=177).1

6MWT=6-minute walk test; ATTR-ACT=Tafamidis in Transthyretin Cardiomyopathy Clinical Trial; ATTR-CM=transthyretin amyloid cardiomyopathy; CMAD=cardiac mechanical assist device; eGFR=estimated glomerular filtration rate; hATTR-CM=hereditary transthyretin amyloid cardiomyopathy; LVAD=left ventricular assist device; mBMI=modifed body mass index; NSAID=non-steroidal anti-inflammatory drug; NT-proBNP=N-terminal pro-B-type natriuretic peptide; NYHA=New York Heart Association; TTR=transthyretin; wtATTR-CM=wild-type transthyretin amyloid cardiomyopathy.

Explore more We have a team ready to support you with any queries.Get in touchLoading

References:

Maurer MS, Schwartz JH, Gundapaneni B, et al. N Eng J Med. 2018;379:1007–1016.VYNDAQEL 61 mg (tafamidis) Summary of Product Characteristics.
PP-VYN-GBR-1125. November 2023

Learn about the efficacy of VYNDAQEL in patients with ATTR-CM

ATTR-ACT results Loading

Learn more about the pathogenesis of ATTR-CM and how VYNDAQEL works

About ATTR-CM and VYNDAQEL Loading

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Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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