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December 31, 2024International Cardivascular Research JournalOpen Access

Efficacy and Safety of Sotatercept in Pulmonary Arterial Hypertension: A Systematic Review

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Why the study?

Sotatercept emerged as a promising option targeting the underlying mechanisms of PAH, but existing evidence on its efficacy and safety needed systematic review.

Does sotatercept improve hemodynamics, exercise capacity, and biomarkers in patients with pulmonary arterial hypertension?

Comparison

Sotatercept evaluation

Design

Systematic review

Follow-up

Up to 24 weeks

Authors

LALeila Ghanbari AfraAMAsma MousaviMMMohammad Mirzaei

Discussion

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Overview

Supports add-on sotatercept in background-treated PAH; confirms consistent efficacy and manageable safety across phase 2/3 trials.

Structured PICO

Does sotatercept improve hemodynamics, exercise capacity, and biomarkers in patients with pulmonary arterial hypertension?

P
Population
323 adult patients (≥18 years) with pulmonary arterial hypertension (PAH), pooled from 9 studies.
I
Intervention
Sotatercept 0.3 mg/kg or 0.7 mg/kg administered for up to 24 to 72 weeks.
C
Comparator
Placebo (in the controlled trials included in the review).
O
Outcome
Clinical parameters including pulmonary artery wedge pressure (PAWP), pulmonary vascular resistance (PVR), mean right atrial pressure (mRAP), mean pulmonary artery pressure (mPAP), 6-minute walk distance (6MWD), and improvements in World Health Organization functional class (WHO FC) over follow-up periods of up to 24 weeks.surrogate

Sotatercept is an effective therapeutic intervention for PAH that significantly reduces pulmonary vascular resistance and improves exercise capacity and heart failure biomarkers, with manageable adverse effects.

Limitations

  • Inability to examine the relationship between drug dosage and disease severity or reported outcomes
  • Timing of adverse event occurrences was not mentioned
  • Duration of adverse effects and how they were controlled or the development of drug tolerance were not addressed
  • Dose variability and small sample sizes in individual studies
  • Full-text access to all articles was not available, preventing a robust meta-analysis

Cite This Study

Afra et al. (2024) studied this question.

synapsesocial.com/papers/6a7ff14e1024bacc969279cbhttps://doi.org/10.5812/icrj-151870
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1B67-21 Sotatercept in Pulmonary Arterial Hypertension: Updated Evidence From Randomized Trials2026
  2. 2D109-12 A Systematic Review and Meta-Analysis of Sotatercept’s Efficacy and Safety in Pulmonary Arterial Hypertension2026
  3. 3Treating Pulmonary Arterial Hypertension With Sotatercept: A Meta-Analysis2024 · 6 citations
  4. 4662: EFFICACY AND SAFETY OF SOTATERCEPT IN PULMONARY ARTERIAL HYPERTENSION: A META-ANALYSIS OF RCTS2026
  5. 5Clinical, hemodynamic, and safety outcomes of sotatercept in pulmonary arterial hypertension: a meta-analysis of randomized trials with time-to-event data2026