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)
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Autoren
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Panagiota Xanthouli
- Thoraxklinik am Universitätsklinikum Heidelberg, Pulmonale Hypertonie, Rheumatologie, Heideberg
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Zixuan Pan
- Thoraxklinik am Universitätsklinikum Heidelberg, Heidelberg
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Alberto Marra
- Thoraxklinik am Universitätsklinikum Heidelberg, Heidelberg
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Nicola Benjamin
- Thoraxklinik Heidelberg, Pneumologie, Studienkoordination, Heidelberg
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Christina Eichstaedt
- Thoraxklinik am Universitätsklinikum Heidelberg, Heidelberg
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Norbert Blank
- Universitätsklinikum Heidelberg, Rheumatologie, Heidelberg
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Eduardo Bossone
- Azienda Ospedaliera Universitaria OO.RR. S.Giovanni di Dio e Ruggi d'Aragona, Salerno, Kardiologie, Salerno, Italy
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Antonio Cittadini
- Universität Neapel Federico II, Department of Translational Medical Science, Napoli, Italien
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Gerry Coghlan
- Royal Free Hospital, London, Kardiologie, London, United Kingdom
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Christopher P. Denton
- Royal Free and University College, Centre for Rheumatology, London, United Kingdom
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Oliver Distler
- UniversitätsSpital Zürich, Rheumaklinik, Zürich, Schweiz
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Benjamin Egenlauf
- Thoraxklinik Heidelberg, Pneumologie, Heidelberg
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Christine Fischer
- Universitätsklinikum Heidelberg, Abteilung für Humangenetik, Heidelberg
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Satenik Harutyunova
- Thoraxklinik Heidelberg, Pneumologie, Heidelberg
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Hanns-Martin Lorenz
- Universitätsklinikum Heidelberg, Medizinische Klinik V, Sektion Rheumatologie, Heidelberg
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Ekkehard Grünig
- Thoraxklinik des Universitätsklinikums Heidelberg, Zentrum für pulmonale Hypertonie, Heidelberg
| Veröffentlicht: | 8. Oktober 2019 |
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Gliederung
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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.
