OPSUMIT® (MACITENTAN) WAS STUDIED IN SERAPHIN*, THE LARGEST LONG-TERM OUTCOMES-BASED PIVOTAL TRIAL OF AN ERA IN PAH1
Long-term outcomes data in both monotherapy AND combination therapy
TRIAL DESIGN:
SERAPHIN was an event-driven, multicenter, long-term (average treatment duration 2 years), randomized, double-blind, placebo-controlled phase 3 trial.2
TRIAL DEMOGRAPHICS2:
- Patients had predominantly WHO FC II-III symptoms
- Etiologies included IPAH/HPAH (57%), PAH-CTD (31%), PAH-CHD with repaired shunts (8%), PAH associated with drugs and toxins (3%), and PAH-HIV (1%)
- Mean patient age was 46 years, and 77% of patients were female
Adapted from Pulido T, et al. N Engl J Med 2013; table 1
* The SERAPHIN study is the first and only study to demonstrate a statistically significant long-term benefit with an ERA Vs. placebo in PAH based on a composite morbidity-mortality primary endpoint.
REFERENCES
- Said K. Macitentan in pulmonary arterial hypertension: The SERAPHIN trial. Glob Cardiol Sci Pract. 2014; 2014(2): 26–30.
- Pulido T, Adzerikho I, Channick RN, et al; for the SERAPHIN Investigators. Macitentan and morbidity and mortality in pulmonary arterial hypertension. N Engl J Med. 2013;369:809-818 and suppl 1-21.