Using sotatercept to treat pulmonary arterial hypertension
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by An Duc Thien Le |
Posted on May 17th, 2023
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The excessive proliferation of smooth muscle and endothelial cells around the pulmonary artery can narrow its diameter and lead to hypertension. Recent studies have found that the transforming growth factor β (TGF-β) plays an important role in this proliferation. Sotatercept is a fusion protein containing the binding portion of the ActRIIA receptor that can bind to TGF-β. Thus, the pharmaceutical company MSD had sponsored a study to investigate the effect of Sotatercept in treating pulmonary arterial hypertension.
The phase 3 clinical trial included 163 patients who have been diagnosed with pulmonary arterial hypertension for an average of 8.8 years. The average age of these participants was 47.9 years old and their average BMI was 26.4. The patients were randomly assigned to receive a subcutaneous injection every 3 weeks of either placebo or sotatercept. The initial dose of sotatercept was 0.3 mg per kilogram of body weight; this was increased to 0.7 mg per kilogram of body weight since the 2nd follow-up visit. When compared to baseline, the 24 weeks of treatment with sotatercept helps increase the walking distance to 34.4 meter per 6 minutes - this is significantly further than the 1.0 meter per 6 minutes in the placebo group. Besides the ease of respiration while exercising, sotatercept reduced the degree of pulmonary vascular resistance by 165.1 dyn·sec·cm−5; whereas, this parameter increased by 32.8 dyn·sec·cm−5. The study also assessed the severity of heart failure using the level of NT-proBNP. Sotatercept helped alleviate heart function as indicated by the 230.3 pg/mL reduction in NT-proBNP level; the study found that heart function in the placebo group deteriorated significantly as the elevated 58.6 pg/mL in NT-proBNP concentration. Besides the clinical benefits, healthcare professionals should consider the adverse events associated with the medication. Patients who were treated with sotatercept experienced more incidence of epistaxis, dizziness, telangiectasia, and thrombocytopenia.
The phase 3 clinical trial included 163 patients who have been diagnosed with pulmonary arterial hypertension for an average of 8.8 years. The average age of these participants was 47.9 years old and their average BMI was 26.4. The patients were randomly assigned to receive a subcutaneous injection every 3 weeks of either placebo or sotatercept. The initial dose of sotatercept was 0.3 mg per kilogram of body weight; this was increased to 0.7 mg per kilogram of body weight since the 2nd follow-up visit. When compared to baseline, the 24 weeks of treatment with sotatercept helps increase the walking distance to 34.4 meter per 6 minutes - this is significantly further than the 1.0 meter per 6 minutes in the placebo group. Besides the ease of respiration while exercising, sotatercept reduced the degree of pulmonary vascular resistance by 165.1 dyn·sec·cm−5; whereas, this parameter increased by 32.8 dyn·sec·cm−5. The study also assessed the severity of heart failure using the level of NT-proBNP. Sotatercept helped alleviate heart function as indicated by the 230.3 pg/mL reduction in NT-proBNP level; the study found that heart function in the placebo group deteriorated significantly as the elevated 58.6 pg/mL in NT-proBNP concentration. Besides the clinical benefits, healthcare professionals should consider the adverse events associated with the medication. Patients who were treated with sotatercept experienced more incidence of epistaxis, dizziness, telangiectasia, and thrombocytopenia.