In a clinical trial, patients taking OPSUMIT® (31.4%) were 45% less likely to have their PAH progress than patients taking a placebo (sugar pill) (46.4%). This means more time without a serious PAH event.
Disease progression included the need for injectable PAH medication or other worsening of PAH (decreased 6MWD, PAH symptoms getting worse, and the need for new PAH treatment). Disease progression can also include less frequent instances of death, or the need for atrial septostomy (a procedure where a hole is placed between the two small chambers of the heart) or lung transplant.
There was a 50% reduction in the risk of PAH-related hospitalization for patients taking OPSUMIT® (n=242) vs the placebo (sugar pill) (n=250). 18.6% of patients receiving OPSUMIT® (n=242) were hospitalized vs 31.6% receiving placebo (sugar pill) (n=250).
The 6-minute walk test (6MWT) measures the distance you can walk in 6 minutes. It is one test that your doctor may perform to assess your condition.
More patients taking OPSUMIT® saw an improvement in functional class (measured by improvement of at least one functional class), which can mean less chest pain, less fatigue, and less shortness of breath.
Functional class is a common way for doctors to assess the seriousness of your PAH, which can help them with making treatment decisions. The higher the functional class, the more severe the disease. According to PAH experts, maintaining or improving functional class is often an important goal of PAH treatment. Improved functional class means you can do more physical activity with fewer limitations. It does not always mean symptom improvement.
The most common side effects occurring more frequently (≥3%) for patients taking OPSUMIT® vs patients taking placebo (sugar pill) were low red blood cell levels (anemia), stuffy nose or sore throat, irritation of the airways (bronchitis), headache, flu, and urinary tract infection.