Reduce PVR by 47%! Johnson Opsumit joins her darafi phase IV clinical to reach major finish line

Actelion, a company owned by Johnson and Johnson, has released data from the OPTIMA studyThis is a forward-looking, multi-center, single-arm, open, phase IV trial that evaluates the efficacy, safety, and tolerability of Opsumit (macitentan) in combination with PDE5 inhibitor tadalafil as an initial oral treatment for newly diagnosed patients with pulmonary hypertension (PAH)A total of 46 PAH patients (WHO Group 1) were enrolled and treated in the study, all of whom were included in efficacy and safety analysisresults showed that, in the 16th week of treatment, the average pulmonary vascular resistance (PVR) endpoint in PAH patients decreased by 47% from the baseline level (the geometric average of 0.53; 95% CI: 0.47, 0.59) in PAH patientsIn addition, the results showed improved hemodynamics, improved functional parameters (including 6 minute walking distance), and improved risk conditionssafety and tolerability results are consistent with previous clinical trials that support the approval and use of Opsumit 10mg once a dayThe most common adverse events in the study were peripheral edema (28.3%), headache (23.9%), diarrhea (19.6%), dyspnea (15.2%), anemia (13.0%) and fatigue (13.0%)In 4 patients, hemoglobin levels were reduced below 10g/dL, and in 1 patient, transaminase levels were 3 times the normal upper limitThree patients were discontinued due to adverse events and 3 patients died during the study periodCauses of death include cardiac arrest, heart failure and multiple organ failure with sepsisPAH is a special type of pulmonary hypertension, where the walls of the pulmonary artery (the blood vessels that lead from the right side of the heart to the lungs) thicken and harden, the blood flow space narrows, and blood pressure risesDespite some progress made in recent years, PAH remains a serious progressive disease with no cure and one in three patients die within five years of diagnosisPAH risk assessment is an important tool for monitoring disease progression and treatment response, with the main therapeutic objective of achieving and maintaining a low risk statethe data from the OPTIMA study is significant because the improvement of PVR is an important indicator of right ventricular function and a key therapeutic goal for treatment of PAH patientsCurrent PAH clinical guidelines recommend pre-emptive combination of double oral therapyThe results of theOPTIMA study confirm the efficacy and safety of Opsumit and Darafi's initial oral double-combination therapy in PAH patients and complement the support for combination therapy as evidence of standard care Opsumit is a product that Johnson and Johnson acquired after it acquired Actelion in 2017 for $30 billion in cash, a dual-acting endothelial receptor antagonist that relaxes the pulmonary arteries and lowers blood pressure In the United States and the European Union, Opsumit has been approved for PAH treatment Opsumit improves patients' motor ability, and a clinical study of WHO functional lyser II-III PAH patients showed that patients who took Opsumit had an average walking distance of 22 meters in the 6th month compared to those who did not take Opsumit note that Opsumit, like any other drug of its kind, has a black-box warning that suggests embryo/fetal toxicity , a PDE5 selective inhibitor from Lilly, was first introduced in the European Union in 2003 to treat erectile dysfunction In 2009, he obtained FDA approval for PAH treatment reference source: NewOPSUMIT ® Data Show Initial Combination Combination With Tadalafil Improved Hemodynamic Clinical and Parameters in Patients In Patients Carey