Bayer announced that The Lancet Respiratory Medicine has published results from the Phase IV REPLACE (Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy) study in which intermediate-risk adult patients with pulmonary arterial hypertension (PAH) (WHO Group 1) transitioned to Adempas® (riociguat) after an insufficient response to phosphodiesterase-5 inhibitor (PDE5i) therapy. Specifically, 41% (45/111) of patients receiving Adempas therapy achieved the composite primary endpoint of clinical improvement in the absence of clinical worsening, compared with 20% (23/113) in the PDE5i group (odds ratio [OR]=2.78, 95% confidence interval (CI) [1.53-5.06]; p=0.0007). The most common adverse events (AEs) were generally consistent with those seen in the pivotal PATENT study. These data, which are part of a collaboration between Bayer and Merck (known as MSD outside the United States and Canada), were previously presented at the 2020 virtual annual meeting of the European Respiratory Society (ERS). The pivotal PATENT-1 trial, a 12-week, multicenter, double-blind, randomized, placebo-controlled study, investigated the efficacy and safety of riociguat for the treatment of adult patients (n=443) with PAH (WHO Group 1) who were treatment-naïve or were pretreated with endothelin receptor antagonists (ERA) or prostanoids (oral, inhaled or subcutaneous [SC]). Improvements were demonstrated in clinically relevant endpoints, including 6-minute walk distance (6MWD) 36 meters (m) (95% CI: 20m " 52m; p · Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form. Concomitant administration with specific phosphodiesterase (PDE)-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE inhibitors (such as dipyridamole or theophylline) is contraindicated. Do not administer within 24 hours of sildenafil. Do not administer 24 hours before or within 48 hours after tadalafil. Patients with Pulmonary Hypertension associated with Idiopathic Interstitial Pneumonias (PH-IIP). Based on data from animal reproduction studies, Adempas may cause embryo-fetal toxicity when administered to a pregnant female and is contraindicated in females who are pregnant. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment, monthly during treatment, and for one month after stopping treatment. Advise females of reproductive potential to use effective contraception during treatment with Adempas and for at least one month after the last dose. For females, Adempas is only available through a restricted program under the Adempas REMS Program. Adempas REMS Program. Females can only receive Adempas through the Adempas REMS Program, a restricted distribution program. Important requirements of the Adempas REMS Program include the following: Prescribers must be certified with the program by enrolling and completing training. All females, regardless of reproductive potential, must enroll in the Adempas REMS Program prior to initiating Adempas. Male patients are not enrolled in the Adempas REMS Program. Female patients of reproductive potential must comply with the pregnancy testing and contraception requirements. Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive Adempas.