Efficacy and safety of ambrisentan in Chinese patients with connective tissue disease-pulmonary arterial hypertension: a post-hoc analysis

Abstract

Background: The efficacy and safety of ambrisentan has been previously evaluated in Chinese patients with pulmonary arterial hypertension (PAH). This post-hoc analysis assessed the efficacy and safety of ambrisentan in a subgroup of connective tissue disease (CTD) patients with PAH. Methods: In this open-label, single-arm study, patients received ambrisentan 5 mg once daily for 12 weeks, followed by 12-week dose titration period (dose up to 10 mg). Efficacy endpoints included change from baseline in exercise capacity (measured by 6-min walk test [6MWT]), N-terminal pro B type natriuretic peptide (NT-proBNP) plasma levels, WHO Functional Class (FC) and Borg Dyspnoea Index (BDI) scores from baseline to weeks 12 and 24. Safety endpoints included time to clinical worsening and incidence of adverse events (AEs). Results: In total, 71 Chinese patients with CTD-PAH were included in this analysis. Ambrisentan treatment significantly improved exercise capacity (6MWT) from baseline (mean: 366.4 m) to week 12 (63.8 m, p < 0.001) and week 24 (73.2 m, p < 0.001). A significant reduction in NT-proBNP levels was observed from baseline (mean: 1837.5 ng/L) to week 12 (− 1156.8 ng/L, p < 0.001) and week 24 (− 1095.5 ng/L, p < 0.001). BDI scores decreased significantly at week 12 (− 0.6, p < 0.001) and week 24 (− 0.4, p = 0.002) from baseline (mean: 2.7). The WHO FC improved in 29 (40.8%) and 34 (47.9%) patients at weeks 12 and 24, respectively. Adverse events were reported in 52 (73.2%) patients. One patient (1.4%) experienced clinical worsening at week 24.

Comparison Between Treadmill and Bicycle Ergometer Exercises in Terms of Safety of Cardiopulmonary Exercise Testing in Patients With Coronary Heart Disease

“…The present study revealed that the overall incidence of CV events in patients with CHD was 3.4%, with the incidence of serious adverse events being only 0.019%. This is consistent with the findings of previous studies performed on CV disease ( 9 ). For instance, the HF-ACTION trial evaluated the safety of CPET in 2,037 patients with heart failure (with a median left ventricular ejection fraction of 25%), in which only 2 cases of ventricular arrhythmias were observed while no fatal events occurred ( 10 ).…”