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Safety of the COMBINATION THERAPY WITH OPSUMIT AND TADALAFIL IN THE OPTIMA STUDY1

Safety and tolerability in the OPTIMA study were consistent with previous data for OPSUMIT in combination with a PDE-5i.1
Median (interquartile range) exposure to the study treatment was 86.5 (53.0, 115.1) weeks.1

References:

[1] Sitbon O, Cottin V, Canuet M, et al. Initial combination therapy of macitentan and tadalafil in pulmonary arterial hypertension. Eur Respir J. 2020 Sep 3;56 (3):2000673.

[2] Opsumit Summary of Product Characteristics. Available at https://www.ema.europa.eu/en/d... product-information/opsumit-eparproduct- information_en.pdf Last Accessed 16.9.2021.

[3] Simonneau G, Channick RN, Delcroix M, et al. Incident and prevalent cohorts with pulmonary arterial hypertension: insight from SERAPHIN. Eur Respir J. 2015 Dec;46 (6):1711-20.

[4] Ministry of health Opsumit approved insert leaflet 15/10/2018.

CP-263149