Journal article
Efficacy and safety of sotatercept in pulmonary arterial hypertension: a meta-analysis of randomized controlled trials
Expert review of respiratory medicine, pp 1273-1281
04 Jul 2025
PMID: 40611681
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Introduction: To evaluate the efficacy and safety of sotatercept, an activin signaling inhibitor, in pulmonary arterial hypertension (PAH). Methods: We searched PubMed, Embase, and the Cochrane Library for randomized controlled trials (RCTs) comparing sotatercept versus placebo in PAH. We calculated pooled risk ratios (RR) and mean differences (MD) with their 95% confidence intervals (CI) using a random-effects model. Heterogeneity was assessed with I-2 statistics. The GRADE approach was used to assess the certainty of evidence. Results: Three RCTs comprising 601 patients were included. Compared to placebo, sotatercept significantly improved 6-minute walk distance (MD 40.57 m; 95% CI 26.64 to 54.5; p < 0.01), and WHO functional class (RR 2.04; 95% CI 1.53 to 2.7; p < 0.01). Sotatercept reduced pulmonary vascular resistance (MD -233.18 dyn<middle dot>sec<middle dot>cm(-5); 95% CI -295.84 to -170.52; p < 0.01) and pulmonary artery pressure (MD -14.94 mmHg; 95% CI -19.62 to -10.27; p < 0.01) at study end. No significant differences were observed in all-cause mortality or NT-proBNP levels. Sotatercept was associated with epistaxis, increased hemoglobin, and telangiectasia adverse events. Conclusions: Sotatercept improves exercise capacity, WHO functional class and pulmonary hemodynamics in PAH, with an acceptable safety profile. Long-term studies are needed to confirm sustained benefits. Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD420251032174.
Metrics
12 Record Views
Details
- Title
- Efficacy and safety of sotatercept in pulmonary arterial hypertension: a meta-analysis of randomized controlled trials
- Creators
- Mohamad Ershed - University of Medicine and Pharmacy of CraiovaAna Beatriz Nardelli da Silva - Universidade Federal do ParáAna Clara Felix de Farias dos Santos - Universidade de São PauloDanhui Heo - University of SzegedDeivyd Vieira Silva Cavalcante - University of North TexasJafar Aljazeeri - Drexel University, Pulmonary, Critical Care, and Sleep (Medicine)
- Publication Details
- Expert review of respiratory medicine, pp 1273-1281
- Publisher
- Taylor & Francis
- Number of pages
- 9
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pulmonary, Critical Care, and Sleep (Medicine)
- Web of Science ID
- WOS:001524711400001
- Scopus ID
- 2-s2.0-105010204110
- Other Identifier
- 991022061627704721
UN Sustainable Development Goals (SDGs)
This publication has contributed to the advancement of the following goals:
InCites Highlights
Data related to this publication, from InCites Benchmarking & Analytics tool:
- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Respiratory System