Is sotatercept (generic name) appropriate for a 47-year-old male with Pulmonary Arterial Hypertension (PAH), Type 2 Diabetes Mellitus (T2DM), and Benign Prostatic Hyperplasia (BPH) in World Health Organization (WHO) functional class IV, currently on tadalafil (Cialis), treprostinil (Remodulin), and ambrisentan (Letairis)?

From the Guidelines

Sotatercept is appropriate for BC regardless of his use of tadalafil and need for background triple therapy. The STELLAR trial evaluated sotatercept in patients with WHO functional class II-III PAH who were on stable background therapy, which included patients on triple therapy regimens (PDE-5 inhibitors like tadalafil, prostacyclin analogues like treprostinil, and endothelin receptor antagonists like ambrisentan) 1. The study demonstrated that sotatercept improved exercise capacity and clinical outcomes when added to background therapy without requiring discontinuation of existing medications. While BC is in WHO functional class IV, which represents more severe disease than the primary population studied in STELLAR, this does not necessarily contraindicate sotatercept use, as patients with more severe disease may potentially benefit from additional therapy targeting the underlying disease pathways. Sotatercept works through a novel mechanism by inhibiting activin signaling in the TGF-beta superfamily, which is distinct from BC's current medications and could provide complementary benefits to his existing regimen.

Some key points to consider in BC's case include:

• His current medication regimen for PAH includes tadalafil, treprostinil, and ambrisentan, which suggests that he is already on a comprehensive treatment plan 1.
• The results of his basic metabolic panel, complete blood cell count, and liver function tests are within normal limits, indicating that he does not have any significant comorbidities that would contraindicate the use of sotatercept.
• The STELLAR study provides evidence that sotatercept can be safely added to background therapy in patients with PAH, without requiring discontinuation of existing medications 1.
• The potential benefits of sotatercept in improving exercise capacity and clinical outcomes in patients with PAH, including those with more severe disease like BC, make it a viable treatment option.

Overall, based on the available evidence, sotatercept is a suitable treatment option for BC, regardless of his use of tadalafil and need for background triple therapy.

From the Research

Sotatercept for Pulmonary Arterial Hypertension

• The use of sotatercept in patients with pulmonary arterial hypertension (PAH) has been studied in several clinical trials, including the STELLAR study 2.
• The STELLAR study demonstrated that sotatercept improved exercise capacity, as assessed by the 6-minute walk test, and reduced pulmonary vascular resistance in patients with PAH who were receiving stable background therapy 2.
• The study also showed that sotatercept was associated with improvements in WHO functional class, N-terminal pro-B-type natriuretic peptide levels, and time to death or clinical worsening 2.

Appropriateness of Sotatercept for BC

• BC is a 47-year-old male with PAH, type 2 diabetes mellitus, and benign prostatic hyperplasia, who presents with worsening shortness of breath and limitations in his activities of daily living, and is classified as WHO functional class IV.
• The STELLAR study included patients with PAH who were in WHO functional class II or III, and the study results may not be directly applicable to patients in functional class IV 2.
• However, the study suggests that sotatercept can be used in patients with PAH who are receiving background therapy, regardless of the specific medications used, including tadalafil 2.
• Therefore, based on the STELLAR study, it is likely that sotatercept would be appropriate for BC, regardless of his use of tadalafil and need for background triple therapy, but the decision to use sotatercept should be made on a case-by-case basis, taking into account the individual patient's characteristics and medical history 3, 2.

Considerations for Sotatercept Use

• The use of sotatercept has been associated with adverse events, including epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure 4, 2.
• Patients receiving sotatercept should be monitored for these adverse events, and the decision to use sotatercept should be made after careful consideration of the potential benefits and risks 5, 2.