Efficacy and Safety of Sotatercept in Pulmonary Arterial Hypertension: A GRADE-Assessed Meta-Analysis of Randomized Trials with Trial Sequential Analysis
Supervisor Name
Anwar Zahran
Supervisor Email
anwarkzahran@gmail.com
University
An-Najah National University
Research field
Medical Sciences
Bio
Anwar K. Zahran, MD, is a Palestinian physician and Research and Teaching Assistant at An-Najah National University. A medical school valedictorian and ECFMG-certified physician, he conducts clinical and medical education research, with interests in neurology, neuroscience, and evidence synthesis. His work includes systematic reviews, meta-analyses, and observational studies, and he contributes to research training and mentorship for medical students with +75 peer-reveiwed publications.
Description
This project evaluates the efficacy and safety of sotatercept added to background therapy for adults with pulmonary arterial hypertension. We conducted a systematic review and meta-analysis of four randomized controlled trials involving 921 participants. Random-effects models were used to pool clinical and safety outcomes, while risk of bias, certainty of evidence, and the strength of cumulative findings were assessed using RoB 2, GRADE, and trial sequential analysis. Sotatercept improved exercise capacity, pulmonary vascular resistance, and functional outcomes, and reduced clinical worsening. However, no significant effect on mortality was demonstrated. The safety analysis found fewer serious adverse events and more bleeding-related events, including epistaxis. The findings offer an updated synthesis of the randomized evidence and highlight the need for longer-term trials to clarify survival benefits and durability.