- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Review, Journal: Emerging therapies and new directions in the treatment of pulmonary arterial hypertension. (Pubmed Central) - Feb 3, 2025
Key updates include the introduction of sotatercept as a second-line therapy leading to a revised definition of maximal medical therapy now encompassing agents from four therapeutic groups (phosphodiesterase-5 inhibitors/soluble guanylate cyclase stimulators, endothelin receptor antagonists, prostacyclin pathway agents, and sotatercept), instead of three (phosphodiesterase-5 inhibitors/soluble guanylate cyclase stimulators, endothelin receptor antagonists, prostacyclin pathway agents)...This review presents these advancements and emphasizes the need for their widespread implementation in clinical practice. At the end, we present new opportunities and challenges in the treatment of pulmonary arterial hypertension in eight Central and Eastern European countries.
- |||||||||| Review, Journal: Shifting Paradigms in the Management of Pulmonary Hypertension. (Pubmed Central) - Jan 28, 2025
Pulmonary artery denervation and balloon pulmonary angioplasty have emerged as viable alternatives in PH that are resistant to drug therapy. This article aims to summarise the key changes and recent advances in diagnosis and managing PH in general, with an emphasis on certain subgroups.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Trial initiation date: Sox-PH: 129 Xenon Imaging in Patients Treated with Sotatercept (clinicaltrials.gov) - Jan 17, 2025
P2, N=14, Not yet recruiting,
Limitations in practice include high cost and unknown long-term effects. Initiation date: Dec 2024 --> Mar 2025
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Journal: Sotatercept: A New Era in Pulmonary Arterial Hypertension. (Pubmed Central) - Jan 12, 2025
Overall, sotatercept represents a landmark advancement in PAH treatment, offering hope for patients and the potential to delay or avoid lung transplantation. Importantly, this marks the beginning of an era of targeted therapies aimed at reverse remodeling in PAH while improving outcomes.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Review, Journal: A Belgian consensus on sotatercept for the treatment of pulmonary arterial hypertension. (Pubmed Central) - Dec 16, 2024
The drug appears to have an acceptable safety profile, although it is associated with an increased risk in developing telangiectasia and biological changes affecting platelet counts and haemoglobin. This study reviews the current evidence on SC sotatercept and provides a Belgian perspective on its place in the future treatment strategy for PAH.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Journal: A new day has come: Sotatercept for the treatment of pulmonary arterial hypertension. (Pubmed Central) - Dec 13, 2024
Sotatercept is a first-in-class, novel activin signaling inhibitor approved for treating PAH based on evolving efficacy and safety evidence. This state-of-the-art review summarizes the current understanding of the mechanism of action, the impact on outcomes that improve how patients feel, function, and survive, and the safety and adverse event profile to inform readers of this breakthrough novel therapy.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Review, Journal: Sotatercept: New drug on the horizon of pulmonary hypertension. (Pubmed Central) - Dec 7, 2024
We provide an overview of the clinical and preclinical evidence of the targeting the activing pathway through sotatercept on the treatment of PAH. We also discuss what other possibilities there are for the application of sotatercept in the setting of pulmonary hypertension other than PAH Group 1.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Journal: Risk assessment models and survival in pulmonary arterial hypertension: a SPAHR analysis. (Pubmed Central) - Nov 16, 2024
Risk prediction was incremental with the number of low-risk criteria met, while improvements in only one of 6MWD, NT-proBNP, or FC showed a modest association with survival. The risk assessment tools predicted outcome in patients across both age categories.
- |||||||||| Review, Journal: New and Emerging Therapeutic Drugs for the Treatment of Pulmonary Arterial Hypertension: A Systematic Review. (Pubmed Central) - Sep 30, 2024
Conversely, udenafil, racecadotril, sotatercept, anastrozole, riociguat, tacrolimus, and ralinepag were found to be safe, well-tolerated, and effective in improving hemodynamic measures and 6-MWDs. This study aims to summarize the developing treatment options currently under clinical trials, highlighting the need for further trials before their application in clinical practice.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Review, Journal: How We Do It: Using Sotatercept in the Care of Patients with Pulmonary Arterial Hypertension. (Pubmed Central) - Sep 11, 2024
Often, recommendations from these data are unclear or too general, due to remaining gaps in knowledge. In this edition of "How I Do It", we provide a case-based discussion of common clinical decisions regarding diagnostic testing, choice of first line agents, escalation of therapy, potential timing of sotatercept, safety awareness, practical use, potential management changes, and the future use of sotatercept in other pulmonary hypertension cohorts.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Journal: Contemporary Treatment of Pulmonary Arterial Hypertension: A US Perspective. (Pubmed Central) - Aug 31, 2024
In this state-of-the-art review, we focus on the placement of this novel agent in the PAH treatment paradigm based on the available evidence, with special focus on the US patient population. This review also provides an expert opinion of the current treatment algorithm on important subgroups of patients with comorbidities from the US perspective.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
SOTATERCEPT FOR PULMONARY ARTERIAL HYPERTENSION: A SYSTEMATIC REVIEW AND META-ANALYSIS (Convention Center Exhibit Hall: Poster Area 3) - Jul 31, 2024 - Abstract #CHEST2024CHEST_4778;
However, further research is warranted to ascertain the long-term effects and effectiveness of Sotatercept in controlling PAH in clinical settings and establish its safety and cost-effectiveness. CLINICAL IMPLICATIONS: Sotatercept is an effective treatment option for Class II and III PAH patients.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
2002: What's New in Pulmonary Vascular Disease: Insights From the 7th World Symposium on PH (Convention Center 205 A) - Jul 31, 2024 - Abstract #CHEST2024CHEST_4402;
Exciting new changes will be described in these proceeding documents with special focus on changes in the hemodynamic definition, new treatment algorithm, including sotatercept, and focus on the comorbidities...3. Learn the new modified treatment algorithm for PAH.
- |||||||||| Adempas (riociguat) / Bayer, Merck (MSD), Opsumit (macitentan) / Nippon Shinyaku, J&J, Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
A CASE OF SEVERE PULMONARY HYPERTENSION ASSOCIATED WITH A MASSIVE PULMONARY ARTERY ANEURYSM (Convention Center 257 AB) - Jul 31, 2024 - Abstract #CHEST2024CHEST_4049;
In this case, a PAA gradually worsened over the course of years in the setting of longstanding PAH, despite treatment with multiple vasodilators. Eventually, the aneurysm became massive and was ultimately managed with dual heart-lung transplant with (thus far) good outcome for the patient.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
SAFETY AND EFFICACY OF SOTATERCEPT IN TREATING PULMONARY ARTERIAL HYPERTENSION: A SYSTEMATIC REVIEW (Convention Center Exhibit Hall: Poster Area 3) - Jul 31, 2024 - Abstract #CHEST2024CHEST_3932;
Ongoing research, such as the SOTERIA study, further supports Sotatercept's potential as a promising therapeutic option for PAH, but careful consideration of adverse effects is essential. We recommend more robust trials and longitudinal studies be conducted.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Review, Journal: Sotatercept: First Approval. (Pubmed Central) - Jun 21, 2024
Sotatercept recently received approval in the USA for the treatment of adults with pulmonary arterial hypertension [World Health Organisation (WHO) Group 1] to increase exercise capacity, improve WHO functional class and reduce the risk of clinical worsening events. This article summarizes the milestones in the development of sotatercept leading to this first approval for pulmonary arterial hypertension.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Journal: Therapeutic approaches for pulmonary hypertension in patients with chronic kidney disease. (Pubmed Central) - Jun 20, 2024
Pulmonary hypertension is common in patients with CKD. Although our understanding of factors leading to pulmonary hypertension in this population have evolved, evidence supporting disease-specific therapy in CKD is limited arguing for larger, long-term studies.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Pulmonary hypertension treatment algorithm and pipeline (C2) - May 31, 2024 - Abstract #ERS2024ERS_4348;
In addition, guidance will be given on the treatment of forms of pulmonary hypertension other than pulmonary arterial hypertension. In addition to approved treatments, the presenter will give insights into recent developments in the treatment of pulmonary hypertension.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Review, Journal: Heritable pulmonary arterial hypertension (Pubmed Central) - May 30, 2024
It also enables the testing of healthy family members. In addition to the PAH patient population particularly served by genetic testing, this article touches on the mode of inheritance and provides insights into the first treatments soon on the market that rebalance the BMPR2 signaling pathway.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Biomarker, Journal: Pulmonary Manifestations of Connective Tissue Diseases. (Pubmed Central) - May 22, 2024
Several potential biomarkers have been identified and there are several promising PAH therapies on the horizon such as the novel fusion protein sotatercept. This chapter provides an overview of PH in systemic sclerosis, with a specific focus on group 1 PAH.
- |||||||||| Winrevair (sotatercept) / BMS, Merck (MSD)
Journal: Bone morphogenetic protein signalling in pulmonary arterial hypertension: revisiting the BMPRII connection. (Pubmed Central) - May 8, 2024
Neither its target cells nor its mechanism of action is fully understood. This review will revisit BMPRII function and its extracellular regulation, summarise how dysregulated BMP signalling in endothelial cells and smooth muscle cells may contribute to PAH pathogenesis, and discuss how novel therapeutics targeting the extracellular regulation of BMP signalling, such as BMP9 and Sotatercept, can be related to restoring BMPRII function.
- |||||||||| Myrbetriq (mirabegron) / Astellas, Winrevair (sotatercept) / BMS, Merck (MSD)
Review, Journal: Connexin43, A Promising Target to Reduce Cardiac Arrhythmia Burden in Pulmonary Arterial Hypertension. (Pubmed Central) - Apr 1, 2024
Discovering novel therapeutic and antiarrhythmic strategies may be challenging for further research. Undoubtedly, such research should include protection of the heart from inflammation and oxidative stress, as these are primary pro-arrhythmic factors that jeopardize cardiac Cx43 homeostasis, the integrity of intercalated disk and extracellular matrix, and, thereby, heart function.
- |||||||||| Winrevair (sotatercept) / BMS, Merck (MSD)
Enrollment change: A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020) (clinicaltrials.gov) - Mar 27, 2024
P3, N=46, Active, not recruiting,
Undoubtedly, such research should include protection of the heart from inflammation and oxidative stress, as these are primary pro-arrhythmic factors that jeopardize cardiac Cx43 homeostasis, the integrity of intercalated disk and extracellular matrix, and, thereby, heart function. N=35 --> 46
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Phase classification: A Phase 2a Study To Evaluate The Pharmacokinetics, Safety, Efficacy, Tolerability, And Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease on Hemodialysis. (clinicaltrials.gov) - Mar 1, 2024
P2, N=50, Completed,
Recruiting --> Active, not recruiting Phase classification: P2a --> P2
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