Riociguat for the Treatment of Pulmonary Arterial Hypertension
The slides in this program describe the results of the Phase III efficacy and safety trial of riociguat for pulmonary arterial hypertension (WHO Group 1) in patients, who were either treatment nåive or were receiving stable dosing on ETRAs or non-intravenous prostanoids. The study design, demographics and principal efficacy and safety results are presented. This study represented the first Phase III trial for this novel guanylate cyclase stimulator, which was subsequently approved in the US for use in Group I PAH patients.
AMBITION Clinical Trial
This short presentation reviews the recently published AMBITION Phase III study. This trial examined the efficacy and safety of ambrisentan plus tadalafil initial combination therapy versus ambrisentan or tadalafil monotherapy in Group I, WHO FC II/III patients. The enrolled patients had not received prior therapy for PAH. This was an event-driven trial using a combined morbidity/mortality endpoint and the slides present both principal efficacy and safety data.
Riociguat for the Treatment of Chronic Thromboembolic Pulmonary Hypertension
This slide set presents essential data from the CHEST-1 Phase 3 clinical trial of the efficacy and safety of riociguat in patients diagnosed with inoperable or recurrent chronic thromboembolic pulmonary hypertension. The slides cover study design and principal efficacy and safety data from this trial. Secondary efficacy endpoint data are also included. This study represented the pivotal trial of this novel oral agent for medical treatment of CTEPH and was instrumental in the approval of riociguat for treatment of WHO Group 4 pulmonary hypertension.
SERAPHIN Clinical Trial
SERAPHIN was a Phase III event-driven, morbidity/mortality trial examining the efficacy and safety of macitentan in WHO Group 1 patients, many of whom were on stable oral or inhaled PAH therapy (excluding ETRAs) at the time of enrollment. This short slide program covers the design and principal safety and efficacy results from the first SERAPHIN publication. The data from this study contributed to the US approval for this medication.