ATTR-ACT and LTE Post Hoc Interim Analysis: Continuous Tafamidis Versus Placebo to Tafamidis10

Additional Analysis   >   Long-term analysis   >   Outcome
  • The aim of this analysis was to examine the LTE of tafamidis meglumine 80 mg or equivalent in ATTR-ACT and the LTE1,10
  • Patients treated with tafamidis meglumine 80 mg in ATTR-ACT continuing with tafamidis meglumine 80 mg followed by tafamidis free acid 61 mg (80 mg/61 mg) in the LTE (continuous tafamidis) were compared to patients treated with placebo in ATTR-ACT who transitioned to tafamidis in the LTE (placebo to tafamidis meglumine 80 mg or 20 mg followed by tafamidis free acid 61 mg in the LTE)10
    • Patients in the tafamidis 20 mg arm in ATTR-ACT were not included in this analysis
  • Data were also compared with a model-based extrapolation of survival in placebo-treated patients in ATTR-ACT beyond 30 months (extrapolated placebo)10
  • Data cut-off for this post hoc interim analysis: March 202010
ATTR-ACT
LTE
Continuous
tafamidis
Placebo to
tafamidis
Tafamidis 80 mg
Continued tafamidis
80 mg
Transitioned to tafamidis
free acid 61 mg*
n=176
Placebo
Re-randomized 2:1 to
tafamidis 80:20 mg
Transitioned to tafamidis
free acid 61 mg*
n=177
*Bioequivalent to tafamidis 80 mg
Baseline
30 months
Protocol amendment
(July 20, 2018)
Data cut-off
(March 20, 2020)
Primary efficacy outcome in the LTE: All-cause mortality, with heart transplant and
implantation of a cardiac mechanical assist device treated as death10

*The FDA-approved dosing is either tafamidis meglumine 80 mg (four 20 mg tafamidis meglumine capsules) orally once daily OR tafamidis free
acid 61 mg (one 61 mg tafamidis free acid capsule) orally once daily.

ATTR-ACT: Tafamidis in Transthyretin Cardiomyopathy Clinical Trial; FDA: Food Drug and Administration; LTE: long-term extension.