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REDUCTION IN PVR

OPSYNVI® Provided Greater Reductions in PVR Compared With Macitentan and Tadalafil Alone1

Change in PVR at Week 16
(OPSYNVI® vs macitentan)1

OPSYNVI® clinical trial PVR results for OPSYNVI® versus Macitentan
  • PVR Change at Week 16
    (% From Baseline Geometric Means)
  • OPSYNVI®
    n=70
  • Macitentan
    n=35
  • Primary Endpoint
  • Ratio of Geometric
  • Means 0.71; P<0.0001
  • (95% CL; 0.61-0.81)
  • 29% REDUCTION P<0.0001 95% CL, -39%, -18%
  • PVR Change at Week 16
    (% From Baseline Geometric Means)
  • OPSYNVI®
    n=86
  • Macitentan
    n=44
  • Primary Endpoint
  • Ratio of Geometric
  • Means 0.72; P<0.0001
  • (95% CL; 0.64-0.80)
  • 28% REDUCTION P<0.0001 95% CL, -36%, -20%
OPSYNVI® clinical trial PVR results for OPSYNVI® versus Macitentan

Change in PVR at Week 16
(OPSYNVI® vs tadalafil)1

OPSYNVI® clinical trial PVR results for OPSYNVI® versus Tadalafil
  • PVR Change at Week 16
    (% From Baseline Geometric Means)
  • OPSYNVI®
    n=70
  • Macitentan
    n=35
  • Primary Endpoint
  • Ratio of Geometric
  • Means 0.71; P<0.0001
  • (95% CL; 0.61-0.81)
  • 29% REDUCTION P<0.0001 95% CL, -39%, -18%
  • PVR Change at Week 16
    (% From Baseline Geometric Means)
  • OPSYNVI®
    n=86
  • Macitentan
    n=44
  • Primary Endpoint
  • Ratio of Geometric
  • Means 0.72; P<0.0001
  • (95% CL; 0.64-0.80)
  • 28% REDUCTION P<0.0001 95% CL, -36%, -20%
OPSYNVI® clinical trial PVR results for OPSYNVI® versus Tadalafil

Treatment with OPSYNVI® (macitentan/tadalafil) resulted in a statistically significant treatment effect in PVR vs macitentan monotherapy and tadalafil monotherapy1

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CL=confidence limits; PAH=pulmonary arterial hypertension; PVR=pulmonary vascular resistance.

Reference: 1. OPSYNVI® (macitentan/tadalafil) full Prescribing Information. Actelion Pharmaceuticals US, Inc.