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Adverse event reporting can be found at the bottom of the page
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Click here for VYNDAQEL®▼ (tafamidis) Prescribing Information.
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
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
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.
References:
Learn about the efficacy of VYNDAQEL in patients with ATTR-CM
Learn more about the pathogenesis of ATTR-CM and how VYNDAQEL works
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PP-UNP-GBR-7812. January 2024