30 March 2021 - - 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 (WHO Group 1) transitioned to Adempas (riociguat) after an insufficient response to phosphodiesterase-5 inhibitor (PDE5i) therapy, German healthcare company Bayer said.

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 [1.53-5.06]; p=0.0007).

The most common adverse events 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.

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 or prostanoids (oral, inhaled or subcutaneous [SC]).

Improvements were demonstrated in clinically relevant endpoints, including 6-minute walk distance 36 meters (m) (95% CI:20m 52m; p