Early treatment with ambrisentan of mildly elevated mean pulmonary arterial pressure associated with systemic sclerosis: a randomized, controlled, double-blind, parallel group study (EDITA study).

ABSTRACT: OBJECTIVE:The objective of this randomized, placebo-controlled, double-blind, parallel group, trial was to assess the effect of ambrisentan on mean pulmonary arterial pressure (mPAP) in patients with systemic sclerosis (SSc) and mildly elevated pulmonary hypertension (PH). METHODS:Thirty-eight SSc patients with mildly elevated mPAP at rest between 21 and 24?mmHg and/or >?30?mmHg during low-dose exercise were randomly assigned to treatment with either ambrisentan 5-10?mg/day or placebo. Right heart catheterization and further clinical parameters were assessed at baseline and after 6?months. The primary endpoint was the difference of mPAP change at rest between groups. RESULTS:After 6?months, the two groups did not differ in the primary endpoint (ambrisentan mPAP -?1?±?6.4?mmHg vs. placebo -?0.73?±?3.59?mmHg at rest, p?=?0.884). However, three patients from the placebo group but none of the ambrisentan group progressed to SSc-associated pulmonary arterial hypertension. Furthermore, ambrisentan treatment showed significant improvements in the secondary endpoints cardiac index (CI) and pulmonary vascular resistance (PVR) at rest (CI 0.36?±?0.66?l/min/m2 vs. -?0.31?±?0.71?l/min/m2, p?=?0.010; PVR -?0.70?±?0.78 WU vs. 0.01?±?0.71 WU, p?=?0.012) and during exercise (CI 0.7?±?0.81?l/min/m2 vs. -?0.45?±?1.36?l/min/m2, p?=?0.015; PVR -?0.84?±?0.48 WU vs. -?0.0032?±?0.34 WU, p?

SUBMITTER: Pan Z 

PROVIDER: S-EPMC6815440 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature