Randomized, double-blind, multinational, placebo-controlled, 12-week, phase 3 study
6MWD = 6-minute walk distance; mPAP = mean pulmonary arterial pressure; PAH = pulmonary arterial hypertension; PATENT-1 = Pulmonary Arterial Hypertension Soluble Guanylate Cyclase-Stimulator Trial; PVR = pulmonary vascular resistance; WHO FC = World Health Organization Functional Class.
6MWD = 6-minute walk distance; CI = confidence interval.
Adempas can be used as monotherapy or in combination
ITT = intention-to-treat.
†Time to clinical worsening was a combined endpoint defined as death (all-cause mortality), heart/lung transplantation, atrial septostomy, hospitalization due to persistent worsening of pulmonary hypertension, start of new PAH-specific treatment, persistent decrease in 6MWD, and persistent worsening of WHO FC.
‡The Kaplan-Meier plot of time to clinical worsening is presented in the figure above. Patients treated with Adempas experienced a significant delay in time to clinical worsening vs placebo-treated patients (p=0.0046; stratified log-rank test). Significantly fewer events of clinical worsening up to Week 12 (last visit) were observed in patients treated with Adempas (1.2%) compared to placebo (6.3%) (p=0.0285, Mantel-Haenszel estimate).
Right heart catheterization was performed at the beginning and end of the study period in 339 patients.
NT-proBNP = n-terminal prohormone of brain natriuretic peptide; PVR = pulmonary vascular resistance.
§Placebo-adjusted mean change from baseline.
6MWD = 6-minute walk distance; SD = standard deviation; WHO FC = World Health Organization Functional Class.
*exploratory subgroup analysis.
Data from the PAH-CHD subgroup analysis are exploratory, as PATENT-1 was not designed to show statistically significant differences in subgroup populations. The primary efficacy analysis was performed on data from the modified intent-to-treat population (all patients who were randomized and received one or more doses of the study drug). The data presented here are observed values and are analyzed descriptively; observed values were used due to the small sample size and the retrospective, exploratory nature of the analyses. The low patient numbers in the PAH-CHD subgroup should be taken into consideration when interpreting the data. Time to clinical worsening was not evaluated in the PAH-CHD subgroup within the PATENT-1 study.