Long-term Extension10
- Patients treated with tafamidis meglumine in ATTR-ACT continued on the same dose (80 mg or 20 mg)
- Patients previously on placebo were re-randomized to receive either tafamidis meglumine 80 mg or 20 mg (2:1 ratio; stratified by genotype)
- July 2018: Protocol amended to transition all patients to tafamidis free acid 61 mg9
441 patients randomized
88 patients assigned to tafamidis
20 mg were not included in this analysis
20 mg were not included in this analysis
Continuous tafamidis
Placebo to tafamidis
176 patients assigned to tafamidis 80 mg
177 patients assigned to placebo
110 patients continued in the LTE
110 patients assigned to tafamidis 80 mg
110 patients assigned to tafamidis 80 mg
82 patients continued in the LTE
54 patients re-randomized to tafamidis 80 mg
28 patients re-randomized to tafamidis 20 mg
54 patients re-randomized to tafamidis 80 mg
28 patients re-randomized to tafamidis 20 mg
July 2018: Protocol amended to transition
all patients to tafamidis free acid 61 mg
all patients to tafamidis free acid 61 mg
July 2018: Protocol amended to transition
all patients to tafamidis free acid 61 mg
all patients to tafamidis free acid 61 mg
ATTR-ACT
LTE
Tafamidis free acid 61 mg capsules were demonstrated to be bioequivalent to tafamidis meglumine 80 mg (4 × 20 mg) capsules at steady state.9
ATTR-ACT: Tafamidis in Transthyretin Cardiomyopathy Clinical Trial; LTE: long-term extension.
