INDICATION (continued)
Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II-III symptoms treated
for an average of 2 years. Patients were treated with OPSUMIT monotherapy or in combination with phosphodiesterase-5 inhibitors or
inhaled prostanoids. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by
congenital heart disease with repaired shunts (8%).
OPSUMIT provided consistent efficacy on the primary endpoint as monotherapy
or in combination with PDE-5 inhibitors or inhaled prostanoids1
Subgroup analysis of the primary endpoint in the SERAPHIN study
OPSUMIT
Placebo
No. of events/ No. of events/
No. of patients No. of patients
Hazard ratio
Characteristic
Hazard ratio
(95% CI)
Overall treatment effect
76/242
116/250
0.55
(0.41, 0.73)
Combination with PDE-5
inhibitors and/or inhaled
or oral prostanoids‡
50/154
68/154
0.62
(0.43, 0.89)
Monotherapy
26/88
48/96
0.45
(0.28, 0.72)
Primary endpoint
45%
Risk Reduction
p<0.0001
Concomitant PAH therapy
at baseline
0.1
1
38%
Risk Reduction
55%
Risk Reduction
10
Favors OPSUMIT Favors Placebo
‡The OPSUMIT indication includes combination with phosphodiesterase-5 inhibitors or inhaled prostanoids, but not oral prostanoids.
In the treatment of pulmonary arterial hypertension (PAH, WHO Group I)...
Don’t delay, treat today—keep disease progression in mind from the start of therapy in FC II and III patients.
OPSUMIT is approved for use as monotherapy or in combination with PDE-5 inhibitors or inhaled prostanoids1
ADVERSE REACTIONS
Most common adverse reactions (more frequent than placebo by ≥3%) were anemia (13% vs 3%), nasopharyngitis/pharyngitis (20% vs 13%),
bronchitis (12% vs 6%), headache (14% vs 9%), influenza (6% vs 2%), and urinary tract infection (9% vs 6%).
DRUG INTERACTIONS
Strong inducers of CYP3A4 such a