SynthesisIndian heart journal
Efficacy and safety of sotatercept in pulmonary arterial hypertension: A systematic review and meta-analysis of randomized controlled trials.
Synthesis in Indian heart journal. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSotatercept, a first-in-class activin signaling inhibitor, represents a paradigm shift in pulmonary arterial hypertension (PAH) by directly targeting pulmonary vascular remodeling. We conducted a meta-analysis of randomized controlled trials (RCTs) to quantify its efficacy and safety.
methodsWe systematically searched PubMed, Embase, and Cochrane Central from inception to October 2025 for RCTs comparing sotatercept with placebo in PAH. The primary outcome was trial-defined clinical worsening (CW). Secondary outcomes included all-cause mortality, multicomponent improvement (MCI), attainment of low-risk status, serious adverse events (SAEs), and bleeding. Data were pooled using a Mantel-Haenszel random-effects model. Risk of bias was assessed with RoB 2.0, certainty of evidence using GRADE, and trial sequential analysis (TSA) was performed to assess conclusiveness.
resultsFour RCTs comprising 921 patients (sotatercept n = 483; placebo n = 438) were included. Sotatercept significantly reduced clinical worsening (OR 0.18, 95 % CI 0.12-0.27) with minimal heterogeneity and TSA-confirmed conclusiveness. All-cause mortality showed a favorable but non-significant trend (OR 0.63, 95 % CI 0.33-1.20). Sotatercept significantly increased MCI (OR 4.68, 95 % CI 1.94-11.31) and attainment of low-risk status (OR 2.77, 95 % CI 1.49-5.17), with moderate heterogeneity. SAEs were reduced (OR 0.72, 95 % CI 0.53-0.99), while bleeding risk was increased, predominantly minor mucocutaneous events (OR 2.84, 95 % CI 1.94-4.15).
conclusionSotatercept markedly reduces clinical worsening and improves multidimensional outcomes in PAH with an acceptable safety profile, supporting its role as a disease-modifying therapy.
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