2022 ESC/ERS Guidelines recommend OPSUMIT® (macitentan) in initial and sequential combination therapy¹

These excerpts are from the 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Find the full guidelines in the October 2022 issue of Eur Heart J.

Humbert M, Kovacs G, Hoeper MM, et al; ESC/ERS Scientific Document Group. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European of Cardiology (ESC) and the European Respiratory Society (ERS). Eur Heart J. 2022;43(38):3618-3731.

OPSUMIT® + tadalafil received the highest class recommendation (Class I, Level B) for initial combination therapy.*^† In addition, OPSUMIT® added to
PDE5 inhibitors or oral/inhaled prostacyclin analogs received the highest class recommendation (Class I, Level B) for sequential combination therapy.¹*^†

2022 ESC/ERS Guidelines recommendation for initial oral drug combination therapy¹

Measure/treatment	Class	Level
OPSUMIT® + tadalafil is recommended for initial combination therapy (Class I, Level B)^1†‡	I	B

2022 ESC/ERS Guidelines recommendation for sequential combination therapy¹

Measure/treatment	Class	Level
The addition of OPSUMIT® to a PDE5 inhibitor or oral/inhaled prostacyclin is recommended for sequential combination therapy^§	I	B

OPSUMIT® was not studied for initial combination therapy or in combination with oral prostanoids in the pivotal PAH study SERAPHIN^2,3
Several other therapies also received a Class I, Level B recommendation for initial and sequential combination therapy¹

OPSUMIT® is an ERA approved to reduce the risks of disease progression and PAH-related hospitalization as both monotherapy AND in combination with PDE5 inhibitors or inhaled prostanoids in PAH (WHO Group I) patients with FC II and III symptoms²

*Class I recommendation is evidence and/or general agreement that a given treatment or procedure is beneficial, useful, or effective. Level B evidence recommendation is data derived from a single randomized clinical trial or large nonrandomized studies.¹

^†In patients without cardiopulmonary comorbidities.¹

^‡Patients with idiopathic, heritable, drug-associated PAH or PAH-associated connective tissue disease; OPSUMIT® is not indicated for drug-associated PAH.^1,2

^§Patients with idiopathic, heritable, or drug-associated PAH; OPSUMIT® is not indicated for drug-associated PAH.^1,2

History of OPSUMIT®

LEARN MORE

SERAPHIN pivotal trial

VIEW RESULTS

ERA=endothelin receptor antagonist; ERS=European Respiratory Society; ESC=European Society of Cardiology; FC=Functional Class; PAH=pulmonary arterial hypertension; PDE5i=phosphodiesterase type 5 inhibitor; WHO=World Health Organization.

References: 1. Humbert M, Kovacs G, Hoeper MM, et al; ESC/ERS Scientific Document Group. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). Eur Heart J. 2022;43(38):3618-3731. 2. OPSUMIT® (macitentan) full Prescribing Information. Actelion Pharmaceuticals US, Inc. 3. Pulido T, Adzerikho I, Channick RN, et al; SERAPHIN Investigators. Macitentan and morbidity and mortality in pulmonary arterial hypertension. N Engl J Med. 2013;369(9):809-818 and Suppl 1-21. doi:10.1056/NEJMoa1213917

EXPAND +

+ +

2022 ESC/ERS Guidelines recommend OPSUMIT® (macitentan) in initial and sequential combination therapy1

2022 ESC/ERS Guidelines recommendation for initial oral drug combination therapy1

2022 ESC/ERS Guidelines recommendation for sequential combination therapy1