Phase 3
Completed N=1,733
Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy
Transthyretin (TTR) Amyloid Cardiomyopathy
Source: ClinicalTrials.gov NCT02791230 ↗
Enrolled (actual)
1,733
Serious AEs
53.9%
Results posted
Feb 2025
Primary outcomePrimary: Time to All-Cause Mortality: Cohort A — 58.7; 35.8 Months — p=0.0001
◆ Published Evidence
Established
63citations · ~21 / year
Improved long-term survival with tafamidis treatment in patients with transthyretin amyloid cardiomyopathy and severe heart failure symptoms.
Summary
Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy
Linked Publications (5)
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Improved long-term survival with tafamidis treatment in patients with transthyretin amyloid cardiomyopathy and severe heart failure symptoms.
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Tafamidis Efficacy Among Octogenarian Patients in the Phase 3 ATTR-ACT and Ongoing Long-Term Extension Study.
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Long-term efficacy of tafamidis in patients with transthyretin amyloid cardiomyopathy by National Amyloidosis Centre stage.
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Long-term tafamidis efficacy in patients with transthyretin amyloid cardiomyopathy by baseline left ventricular ejection fraction.
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Early Access to Tafamidis for Patients With Transthyretin Amyloid Cardiomyopathy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to All-Cause Mortality: Cohort A |
58.7; 35.8 | 0.0001 sig |
| PRIMARY Number of Participants With All-Cause Mortality Events: Cohort B |
345 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) |
168; 79; 1294 | — |
Eligibility Criteria
Inclusion Criteria
Cohort A: Completion of 30 months of study treatment on Pfizer Protocol B3461028
Cohort B: Patients in specific countries diagnosed with ATTR-CM who did not previously participate in Pfizer Study B3461028
Exclusion Criteria
-Liver and/or heart transplant, or implanted cardiac mechanical assist device
Data sourced from ClinicalTrials.gov (NCT02791230) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.