Evidence map›Paper›PMID 40668414›Full record

SynthesisNaunyn-Schmiedeberg's archives of pharmacology2025

Efficacy and safety of sotatercept in pulmonary arterial hypertension: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis.

Laila Shalabi, Shehroze Tabassum, Bashar M Al Zoubi, Hosam I Taha, Ibrahim Gowaily, Mohamed Abuelazm

Abstract readSystematic ReviewMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in Naunyn-Schmiedeberg's archives of pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Laila ShalabiFaculty of Medicine, Gharyan University, Gharyan, Libya. shalabilaila55@gmail.com.ORCID 0000-0001-7334-9711
Shehroze TabassumDepartment of Internal Medicine, The Wright Center for Graduate Medical Education, Scranton, PA, USA.
Bashar M Al ZoubiFaculty of Medicine, The Hashemite University, Zarqa, Jordan.
Hosam I TahaFaculty of Medicine, Tanta University, Tanta, Egypt.
Ibrahim GowailyFaculty of Medicine, Tanta University, Tanta, Egypt.
Mohamed AbuelazmFaculty of Medicine, Tanta University, Tanta, Egypt.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pulmonary arterial hypertension (PAH) is a progressive disease characterized by pulmonary vascular remodeling and high mortality. Sotatercept, a novel activin signaling inhibitor, targets the underlying vascular pathology and offers therapeutic potential beyond current vasodilator-based therapies. A comprehensive search of PubMed, Web of Science, SCOPUS, and the Cochrane Library was performed up to April 2, 2025. Only randomized controlled trials (RCTs) comparing sotatercept to placebo in adults with PAH were included. Outcomes were pooled using random-effects models and reported as mean differences (MD) or risk ratios (RR) with 95% confidence intervals (CI). Trial sequential analysis (TSA) was conducted for statistically significant outcomes. PROSPERO ID: CRD420251031657. Three RCTs and 601 patients were included. Sotatercept significantly improved 6-min walk distance (MD = 40.17 m; 95% CI 15.14-65.19), decreased NT-proBNP (MD = - 1149.48 pg/mL; 95% CI - 1890.21 to - 458.73), improved WHO functional class (RR = 2.04; 95% CI 1.53-2.70), and decreased pulmonary vascular resistance (MD = - 214.58; 95% CI - 217.54 to - 211.62). Also, sotatercept decreased all-cause mortality (RR = 0.46; 95% CI 0.22-0.98) and right ventricular failure (RR = 0.26; 95% CI 0.09-0.75); however, it increased thrombocytopenia risk (RR = 2.01; 95% CI 1.01-3.98). Sotatercept significantly improves exercise capacity, cardiac biomarkers, functional status, and pulmonary hemodynamics in patients with PAH while reducing all-cause mortality and right ventricular failure. Despite a mild increase in the risk of thrombocytopenia, it remains a promising disease-modifying therapy.

Indexed as

Antihypertensive AgentsPulmonary Arterial HypertensionRecombinant Fusion ProteinsHumansRandomized Controlled Trials as TopicTreatment OutcomeAntihypertensive AgentsRecombinant Fusion ProteinsPulmonary arterial hypertensionSotaterceptTrial sequential analysis

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.