Trial reportArquivos brasileiros de cardiologia2025
Patisiran Treatment in the Brazilian Subpopulation of the Phase 3 APOLLO-B Study in Transthyretin Amyloidosis with Cardiomyopathy: Post Hoc Analysis.
Trial report in Arquivos brasileiros de cardiologia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03997383 (APOLLO-B), which is not on this map. Cited by 3 papers.
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The trial behind it
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APOLLO-B: A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Patisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
Who cites it
3 citing papers in PubMed.
- Biomarker-Imaging Dissociation in Wild-Type Cardiac Amyloidosis after Treatment with Patisiran.Arquivos brasileiros de cardiologia · 2026Article
- Importance of Developing New Tools to Assess Cardiac Amyloidosis Using Echocardiography.Echocardiography (Mount Kisco, N.Y.) · 2025Article
- Patisiran in the Treatment of Cardiac Amyloidosis: Good for the World and Good for Brazil.Arquivos brasileiros de cardiologia · 2025Article
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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatisiran rapidly knocked down transthyretin and preserved functional capacity in patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM) in the global Phase 3 APOLLO-B study (NCT03997383).
objectivesTo evaluate patisiran efficacy and safety in post hoc analysis of the Brazilian subpopulation of APOLLO-B.
methodsPatients were randomized 1:1 to patisiran 0.3 mg/kg or placebo every 3 weeks for 12 months. The primary endpoint was the change from baseline (CFB) in functional capacity (6-minute walk test [6MWT]) at Month 12. Secondary endpoints included CFB to Month 12 in the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) score. Exploratory endpoints included CFB in cardiac biomarkers and Perugini grade of cardiac uptake during technetium-99m scintigraphy.
resultsForty-two patients enrolled in Brazil (patisiran, n=20; placebo, n=22). Patisiran showed benefit in 6MWT and KCCQ-OS scores vs. placebo; CFB (95% confidence interval [CI]) in 6MWT (median) and KCCQ-OS scores (least squares mean) was -2.0 m (-58.5, 42.9) and 9.37 (1.93, 16.81) points with patisiran vs. -30.1 m (-72.2, 3.5) and 2.62 (-4.68, 9.92) points for placebo. For cardiac biomarkers, the mean fold-change from baseline (95% CI) for N-terminal prohormone B-type natriuretic peptide and troponin I was 1.31 (1.06, 1.61) and 1.12 (0.94, 1.34) for patisiran, and 1.71 (1.39, 2.10) and 1.28 (1.08, 1.53) for placebo, respectively. Perugini grade improved in 11/18 (61.1%) and 0/10 evaluable patients with patisiran and placebo, respectively. There were no deaths in the patisiran group vs. 3 in the placebo group.
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