Physicians' Academy for Cardiovascular Education

80 mg tafamidis reduces mortality compared to 20 mg in ATTR-CM patients

News - June 29, 2020

Tafamidis 80 mg demonstrates a significant survival benefit over tafamidis 20 mg in patients with transthyretin amyloid cardiomyopathy

HFA Discoveries 2020 webinar presented by Thibaud Damy (Creteil, France)

Introduction and methods

In the ATTR-ACT trial (Tafamidis in Transthyretin Cardiomyopathy), treatment with tafamidis meglumine resulted in a reduction in mortality and CV-related hospitalization compared to placebo in patients with transthyretin amyloid cardiomyopathy (ATTR-CM). This was in a primary comparison of pooled doses of 20 mg and 80 mg tafamidis. The trial was not designed for a definitive dose assessment. Patients who completed the ATTR-ACT trial were eligible to enroll in a long-term extension study (LTE).

This study evaluated the effect of tafamidis 80 mg compared to tafamidis 20 mg on mortality using data from the ATTR-ACT trial and the LTE study. Association were corrected for the following prognostic factors of survival: age, NT-proBNP, and functional capacity, measured by 6-minute walk test distance (6MWT).

In ATTR-ACT, 441 patients were randomized to 80 mg tafamidis, 20 mg tafamidis or placebo in a 2:1:2 ratio. After 30 months, patients in the LTE study who were on 80 mg tafamidis continued their treatment, as well as patients on 20 mg tafamidis. Patients on placebo were re-randomized in a 2:1 fashion to 80 mg tafamidis or 20 mg tafamidis. On July 2018 there was a protocol amendment to transition all LTE study participant to a new formulation of tafamidis free acid 61 mg, which is bioequivalent to tafamidis meglumine 80 mg.

Main results


Benefit of 80 mg tafamidis over 20 mg was evident after longer follow-up, with significant reduction in mortality after 51 months in patients with ATTR-CM. The authors of the study concluded that these findings contribute to the evidence that tafamidis 80 mg is the preferred dose in patients with ATTR-CM.

- Our reporting is based on the information provided at HFA Discoveries -

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