Artikel
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)
Suche in Medline nach
Autoren
Veröffentlicht: | 8. Oktober 2019 |
---|
Gliederung
Text
Background: 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 mPAP.
Methods: Thirty-eight SSc-patients with mildly elevated mPAP at rest between 21-24mmHg and/or >30mmHg during low dose exercise were randomly assigned to treatment with either ambrisentan 5-10mg/day or placebo. Right heart catheterization and further clinical parameters were assessed at baseline and after 6 months. The primary end-point 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±6.4mmHg vs. placebo -0.73±3.59mmHg at rest, p=0.884). However, three patients from the placebo group but none of the ambrisentan group progressed to SSc-associated PAH. Furthermore, ambrisentan treatment showed significant improvements in the secondary endpoints cardiac index (CI) and pulmonary vascular resistance (PVR) at rest (CI: 0.36±0.66l/min/m2 vs. -0.31±0.71l/min/m2, p=0.010; PVR: -0.70±0.78WU vs. 0.01±0.71WU, p=0.012) and during exercise (CI: 0.7±0.81l/min/m2 vs. -0.45±1.36l/min/m2, p=0.015; PVR: -0.84±0.48WU vs. -0.0032±0.34WU, p <0.0001).
Conclusion: This is the first randomized, double-blind, placebo-controlled study testing the effect of ambrisentan in patients with mildly elevated mPAP and/or exercise PH. The primary endpoint change in mPAP did only tendentially improve in the Ambrisentan group, but the significant improvement of other hemodynamic parameters pointing to a possible benefit of ambrisentan and will be helpful to design future trials.