Author’s Conclusions10
Post hoc interim analysis of long-term efficacy and safety data showed:
| Patients initially randomized to placebo in ATTR-ACT had poorer survival in the LTE than patients randomized to tafamidis from the start of ATTR-ACT | Upon transition to treatment with tafamidis, survival appeared to improve in patients treated with placebo in ATTR-ACT, regardless of the genotype or baseline NYHA classification | No new safety concerns with longer term follow-up or transition to 61 mg formulation |
- The LTE post hoc interim analysis results highlight the importance of early diagnosis and treatment initiation in ATTR-CM
- In patients with advanced disease, tafamidis treatment may still provide survival benefit
- At a median follow-up of ~58 months, this analysis demonstrated long-term reduction in mortality with the approved tafamidis dose in patients with ATTR-CM
ATTR-ACT: Transthyretin Amyloidosis Cardiomyopathy Clinical Trial; ATTR-CM: transthyretin amyloid cardiomyopathy; LTE: long-term extension; NYHA: New York Heart Association.
