Patient dramatization
SERAPHIN: The first long-term outcome trial in PAH (average treatment 2 years)
to demonstrate the use of both monotherapy and combination therapy to delay
disease progression1,2
Patients were treated with OPSUMIT monotherapy or in combination with PDE-5 inhibitors or inhaled prostanoids1
SERAPHIN included both incident (recently diagnosed) and prevalent (previously diagnosed) patients3
Overall, the median time from diagnosis was 15 months, ranging from 1 day to 36 years3
25% of patients were diagnosed less than 6 months prior to enrollment in the study3
SERAPHIN was a randomized, double-blind, placebo-controlled, event-driven outcome study to assess the effect of OPSUMIT on disease
progression (time to first significant morbidity or mortality event), as defined by death, atrial septostomy, lung transplantation, initiation of
IV or SC prostanoids, or clinical worsening of PAH (decreased 6MWD, worsened PAH symptoms, and need for additional PAH treatment).1,2
WARNINGS AND PRECAUTIONS (continued)
Hepatotoxicity
Other ERAs have caused elevations of aminotransferases, hepatotoxicity, and liver failure. The incidence of elevated aminotransferases in the
SERAPHIN study >3 × ULN was 3.4% for OPSUMIT vs 4.5% for placebo, and >8 × ULN was 2.1% vs 0.4%, respectively. Discontinuations for hepatic
adverse ev