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Return to previous pageFor the chronic treatment of adults with pulmonary arterial hypertension
(PAH, WHO Group I and WHO Functional Class [FC] II-III)1
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OPSYNVI® (macitentan/tadalafil) was proven to reduce PVR more than tadalafil monotherapy or macitentan monotherapy. Most common adverse reactions are edema/fluid retention (21%), anemia (19%), and headache/migraine (18%).1
Efficacy and safety of OPSYNVI® were studied in A DUE. OPSYNVI® reduced PVR by 29% vs macitentan monotherapy (GMR 0.71 [95% CL, 0.61-0.82]; P<0.0001) and 28% vs tadalafil monotherapy (GMR 0.72 [95% CL, 0.64-0.80]; P<0.0001).
Actor
portrayals.
OPSYNVI® (macitentan/tadalafil) was proven to reduce PVR more than tadalafil monotherapy or macitentan monotherapy. Most common adverse reactions are edema/fluid retention (21%), anemia (19%), and headache/migraine (18%).1
Efficacy and safety of OPSYNVI® were studied in A DUE. OPSYNVI® reduced PVR by 29% vs macitentan monotherapy (GMR 0.71 [95% CL, 0.61-0.82]; P<0.0001) and 28% vs tadalafil monotherapy (GMR 0.72 [95% CL, 0.64-0.80]; P<0.0001).
OPSYNVI®—the first and only US FDA-approved single-tablet dual-combination therapy for PAH1,2
Part of the Johnson & Johnson PAH portfolio—
OPSYNVI® targets 2 of the foundational pathways: endothelin and nitric oxide.1,3
CL=confidence level; FC=Functional Class; FDA=US Food and Drug Administration; GMR=ratio of geometric means; PVR=pulmonary vascular resistance; WHO=World Health Organization.
References: 1. OPSYNVI® (macitentan/tadalafil) full Prescribing Information. Actelion Pharmaceuticals US, Inc. 2. Grünig E, Jansa P, Fan F, et al. Randomized trial of macitentan/tadalafil single-tablet combination therapy for pulmonary arterial hypertension. J Am Coll Cardiol. 2024;83(4):473-484. 3. 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.
