Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comment
. 2021 Jun;23(6):1057-1058.
doi: 10.1002/ejhf.2074. Epub 2021 Feb 16.

Reply to the letter regarding the article 'Efficacy and safety of tafamidis doses in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and long-term extension study'

Thibaud Damy  1 , Marla B Sultan  2 , Ronald Witteles  3
Affiliations
Comment

Reply to the letter regarding the article 'Efficacy and safety of tafamidis doses in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and long-term extension study'

Thibaud Damy et al. Eur J Heart Fail. 2021 Jun.
No abstract available

PubMed Disclaimer

Figures

Figure 1
Figure 1
ATTR‐ACT and long‐term extension (LTE) study design. In ATTR‐ACT, 441 patients with transthyretin amyloid cardiomyopathy were randomized (2:1:2) to tafamidis 80 mg, tafamidis 20 mg, or placebo once daily for 30 months. Upon completion of ATTR‐ACT, patients could enrol in the LTE and continued to receive the dose they had been randomized to in ATTR‐ACT, except for those who had been in the placebo group in the 30‐month study; these patients were re‐randomized (2:1) to 80 or 20 mg tafamidis. As of 20 July 2018, the LTE protocol was amended to transition all patients to tafamidis free acid 61 mg; a new, single‐capsule formulation bioequivalent to the tafamidis meglumine 80 mg used in ATTR‐ACT. In total, 252 patients continued in the LTE. Patients were treated with tafamidis 80 mg or 20 mg (up to the protocol amendment) for a median of 39 months. In the analysis of ATTR‐ACT combined with the LTE (as of the data cut‐off), patients were treated with tafamidis for a median follow‐up of 51 months. The LTE is ongoing.
See this image and copyright information in PMC

Comment on

References

    1. Damy T, Garcia‐Pavia P, Hanna M, Judge DP, Merlini G, Gundapaneni B, Patterson TA, Riley S, Schwartz JH, Sultan MB, Witteles R. Efficacy and safety of tafamidis doses in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR‐ACT) and long‐term extension study. Eur J Heart Fail 2021;23:277–285. - PMC - PubMed
    1. Maurer MS, Schwartz JH, Gundapaneni B, Elliott PM, Merlini G, Waddington‐Cruz M, Kristen AV, Grogan M, Witteles R, Damy T, Drachman BM, Shah SJ, Hanna M, Judge DP, Barsdorf AI, Huber P, Patterson TA, Riley S, Schumacher J, Stewart M, Sultan MB, Rapezzi C; ATTR‐ACT Study Investigators . Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med 2018;379:1007–1016. - PubMed