A first-of-its-kind treatment combining macitentan and tadalafil in a once-daily pill.
Discover the benefits of a once-daily, 2-in-1 combination therapy, showing greater reductions in PVR* compared to each as a single therapy.
Pulmonary vascular resistance (PVR) is the resistance that blood flow encounters as it flows through the blood vessels in the lungs and to the upper left chamber of your heart.
The efficacy and safety of OPSYNVI® was studied in a clinical trial with 187 adults with PAH (WHO Group 1 and WHO FC II-III). PVR reduction was compared at 16 weeks between patients taking OPSYNVI® (n=108) versus those taking macitentan alone (n=35) and versus those taking tadalafil alone (n=44).
WHO=World Health Organization; FC=Functional Class
OPSYNVI® was proven to have greater reductions in PVR than tadalafil or macitentan alone.
The key findings of this study showed that OPSYNVI® resulted in a 29% greater reduction in PVR versus macitentan alone, and a 28% greater reduction versus tadalafil alone.
Percent PVR Reductions
From Start of Study to Week 16
OPSYNVI®
(n=70)
-45%
Macitentan
(n=35)
-23%
OPSYNVI®
(n=86)
-44%
Tadalafil
(n=44)
-22%
PVR is measured in dyn x s/cm5
OPSYNVI® Delivers Consistent PVR Results Whether Newly Diagnosed or Previously Treated
Consistent effect of OPSYNVI® on PVR was seen across subgroups of age, sex, race, geographical region, and baseline functional class. Additionally, consistent effect was observed in patients who were either newly diagnosed or had been previously treated with an ERA or PDE5i.
OPSYNVI® Safety Profile
The nature of the side effects was consistent with each of the individual components, macitentan and tadalafil, alone.
OPSYNVI® Side Effects
The side effects (≥3%) of OPSYNVI® include too much fluid in your body and swelling caused by too much fluid, low red blood cell levels, headache/migraine, abdominal pain, low blood pressure, muscle pain, nasal congestion, nausea, increased uterine bleeding, back pain, temporary reddening of the skin, vomiting, heart palpitations, pain in arms or legs, and nose bleed.
Learn How OPSYNVI® Can Help You Manage Your PAH
Download the OPSYNVI® brochure for quick access to the benefits and patient support options available to you.
Download Brochure
