Trial reportEuropean journal of heart failure2021
Efficacy and safety of tafamidis doses in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and long-term extension study.
Trial report in European journal of heart failure, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 92 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A multicenter, international, phase 3, double-blind, placebo-controlled, randomized study to evaluate the efficacy, safety, and tolerability of daily oral dosing of tafamidis meglumine (pf-06291826) 20 mg or 80 mg in comparison to placebo in subjects diagnosed with transthyretin cardiomyopathy (ttr-cm)
A phase 3 multicenter, open-label study to evaluate the safety of daily oral dosing of tafamidis meglumine (pf-06291826-83) 20 mg or 80 mg [or tafamidis (pf-06291826-00) 61 mg] in subjects diagnosed with transthyretin cardiomyopathy (attr-cm)
Who cites it
92 citing papers in PubMed, 3 syntheses or guidelines pooled it, 204 citations in OpenAlex.
- Kidney Disease and Heart Failure: Recent Advances and Current Challenges: Conclusions From a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference.JACC. Heart failure · 2026Guideline
- Mexican position paper for the diagnosis and treatment of cardiac amyloidosis.Archivos de cardiologia de Mexico · 2024Guideline
- Chemistry, Biological Properties, and Bio-analysis of Tafamidis, a New Transthyretin Stabilizer: A Systematic Review.Cardiovascular & hematological agents in medicinal chemistry · 2024Pooled it
- Long-term efficacy of tafamidis in patients with transthyretin amyloid cardiomyopathy by National Amyloidosis Centre stage.European journal of heart failure · 2025Trial
- Effect of Tafamidis on Cardiac Function in Patients With Transthyretin Amyloid Cardiomyopathy: A Post Hoc Analysis of the ATTR-ACT Randomized Clinical Trial.JAMA cardiology · 2024Trial
- Health impact of tafamidis in transthyretin amyloid cardiomyopathy patients: an analysis from the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and the open-label long-term extension studies.European heart journal. Quality of care & clinical outcomes · 2022Trial
- Specific treatment of ATTR-CM in Germany-expert consensus of the German Society of Amyloid Diseases (DGAK) and German Cardiac Society (DGK).Clinical research in cardiology : official journal of the German Cardiac Society · 2026Review
- Phenotypic Considerations for Tafamidis Use in a Real-World Cohort of Older Patients with Transthyretin Amyloid Cardiomyopathy.Cardiology and therapy · 2026Article
- Cardiovascular-Related Mortality and Hospitalizations in Patients with Transthyretin Amyloid Cardiomyopathy Treated with Tafamidis: A Post Hoc Analysis of the Phase 3 ATTR-ACT and Long-Term Extension.Cardiology and therapy · 2026Article
- Impact of Tafamidis on Transthyretin Concentration and Its Relation to All-Cause Mortality in Patients with Transthyretin Amyloid Cardiomyopathy: An Analysis from ATTR-ACT.Cardiology and therapy · 2026Article
- Functional Stability Measured by Changes in the 6-min Walk Test in Patients Treated with Tafamidis Versus Placebo: Post hoc Analysis from ATTR-ACT.Cardiology and therapy · 2026Article
- Transthyretin Cardiac Amyloidosis in Women: Underdiagnosis, Sex-Specific Phenotypic Expression and Therapeutic Response.Journal of clinical medicine · 2026Review
- Cliramitug for depletion of cardiac amyloid transthyretin: long-term follow-up of the NI006-101 trial.Nature medicine · 2026Article
- Differential Transthyretin Stabilization in Patients With Wild Type and Variant Transthyretin Amyloidosis.JACC. CardioOncology · 2026Article
- Wearables for Telemonitoring in ATTR-Amyloidosis: Current Perspectives.Sensors (Basel, Switzerland) · 2026Review
- Investigation of Acoramidis-based ionic liquids as potential stabilizers of transthyretin using DFT calculations, molecular docking, and ADMET studies.Scientific reports · 2026Article
- Cardiovascular Mortality in Amyloidosis: Long-Term Trends, Disparities, and Projections in the United States.Risk management and healthcare policy · 2026Article
- Hereditary Transthyretin Cardiac Amyloidosis Associated with Two Pathogenic Variants in the TTR Gene.Arquivos brasileiros de cardiologia · 2026Article
- Tafamidis Reduces Death and Hospitalization for Acute Heart Failure in Octogenarian Patients With Transthyretin Cardiac Amyloidosis: A Propensity Score-Weighted Cohort Study.Journal of the American Heart Association · 2025Article
- Clinical phenotype and prognosis of real-world patients with wild-type transthyretin amyloid cardiomyopathy treated with tafamidis.European journal of heart failure · 2025Observational
32 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
11 authors at 7 institutions in 4 countries.
Funding
Abstract
aimsTafamidis is an effective treatment for transthyretin amyloid cardiomyopathy (ATTR-CM) in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT). While ATTR-ACT was not designed for a dose-specific assessment, further analysis from ATTR-ACT and its long-term extension study (LTE) can guide determination of the optimal dose. METHODS AND
resultsIn ATTR-ACT, patients were randomized (2:1:2) to tafamidis 80 mg, 20 mg, or placebo for 30 months. Patients completing ATTR-ACT could enrol in the LTE (with placebo-treated patients randomized to tafamidis 80 or 20 mg; 2:1) and all patients were subsequently switched to high-dose tafamidis. All-cause mortality was assessed in ATTR-ACT combined with the LTE (median follow-up 51 months). In ATTR-ACT, the combination of all-cause mortality and cardiovascular-related hospitalizations over 30 months was significantly reduced with tafamidis 80 mg (P = 0.0030) and 20 mg (P = 0.0048) vs. placebo. All-cause mortality vs. placebo was reduced with tafamidis 80 mg [Cox hazards model (95% confidence interval): 0.690 (0.487-0.979), P = 0.0378] and 20 mg [0.715 (0.450-1.137), P = 0.1564]. The mean (standard error) change in N-terminal pro-B-type natriuretic peptide from baseline to Month 30 was -1170.51 (587.31) (P = 0.0468) with tafamidis 80 vs. 20 mg. In ATTR-ACT combined with the LTE there was a significantly greater survival benefit with tafamidis 80 vs. 20 mg [0.700 (0.501-0.979), P = 0.0374]. Incidence of adverse events in both tafamidis doses were comparable to placebo.
conclusionTafamidis, both 80 and 20 mg, effectively reduced mortality and cardiovascular-related hospitalizations in patients with ATTR-CM. The longer-term survival data and the lack of dose-related safety concerns support tafamidis 80 mg as the optimal dose. CLINICAL
trial registrationClinicalTrials.gov NCT01994889; NCT02791230.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.