Drug updated on 7/4/2024
Dosage Form | Injection (45 mg, 60 mg lyophilized cake or powder in a single-dose vial) |
Drug Class | Activin signaling inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events.
Latest News
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Summary
- Sotatercept-csrk (Winrevair) is indicated for the treatment of adults with pulmonary arterial hypertension to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events.
- The information was derived from two systematic reviews/meta-analyses that focused on Winrevair's safety and effectiveness in treating pulmonary arterial hypertension.
- Compared to other potential therapies such as ROCK inhibitors, BMP2 inhibitors, estrogen inhibitors, and AMPK activators like metformin; Sotatercept shows promise in modifying PAH pathophysiology with a comparative profile of safety. However, further research is needed to confirm these benefits.
- Patients treated with Sotatercept experienced significant improvements in pulmonary vascular resistance and World Health Organization functional class versus those receiving a placebo. Adverse event rates were comparable between the Sotatercept and placebo groups.
- A notable difference observed was an increase in hemoglobin levels seen in patients treated with Sotatercept, which points towards its erythropoietic effects. This necessitates further investigation regarding its benefits or detriments given the adverse impact of anemia and polycythemia on PAH prognosis.
- Both studies signify relevance across a broad range of PAH patient populations but also indicate complexity due to disease etiology affecting assessment outcomes. Specifically mentioned is the prevalence of anemia among PAH patients indicating that this subgroup might require specific consideration when using this drug due to its effect on hemoglobin levels.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Winrevair (sotatercept-csrk) Prescribing Information | 2024 | Merck & Co., Rahway, New Jersey |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
A Systematic Review of Novel Therapies of Pulmonary Arterial Hypertension | 2024 | American Journal of Cardiovascular Drugs |
Navigating the Sotatercept landscape: A meta-analysis of clinical outcomes | 2024 | Clinical Cardiology |