N/A
N=125
Effect of Pharmacologic Interaction Between ERAs and PDE-5 Inhibitors on Medication Serum Levels and Clinical Disease Status in Patients With PAH
Pulmonary Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02484807 ↗Enrolled (actual)
125
Serious AEs
—
Results posted
Feb 2020
Primary outcome: Primary: Characterisation of Medication Levels — 5.54; 2.18; 1.81; 1.53 MOM
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- no intervention, only observation of different groups (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Heidelberg University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Characterisation of Medication Levels |
5.54; 2.18; 1.81; 1.53; NA; NA | — |
| SECONDARY Impact of Medication Adjustment |
0.42; 1.59 | — |
| SECONDARY Clinical Relevance 6 Minute Walking Distance |
396; 436 | — |
| SECONDARY Clinical Relevance NTproBNP |
2204; 1181 | — |
| SECONDARY Clinical Relevance Echocardiography Systolic Pulmonary Arterial Pressure (sPAP) |
60.6; 60.2 | — |
| SECONDARY Clinical Relevance Echocardiography Tricuspid Annular Plane Systolic Excursion (TAPSE) |
21.9; 21.5 | — |
| SECONDARY Clinical Relevance Blood Gas Analysis Oxygen Saturation |
92.2; 93.0 | — |
Summary
The development of disease-targeted medication for the treatment of pulmonary arterial hypertension (PAH) has significantly improved within the last years, leading to the development of 10 approved agents. Combination treatment with Endothelin-Receptor-Antagonists (ERA) and Phosphodiesterase-Type-5-Inibitors (PDE-5-Inhibitor) has become increasingly important for the treatment of PAH. In a recent press release, the results of the AMBITION study reported that an upfront combination treatment immediately after diagnosis leads to a delayed disease progression [4]. Thus, the question if there is a clinically relevant pharmaco-dynamic drug-drug interaction is of rising interest.
Eligibility Criteria
Inclusion Criteria
- Men and women ≥ 18 years old
- Diagnosis of PAH according to ESC/ERS-guidelines: patients with manifest pulmonary arterial hypertension, mean pulmonary arterial pressure ≥25mmHg, measured by right heart catheterization.
- Combination treatment with ERA (Bosentan, Ambrisentan or Macitentan) and PDE-5-Inhibitor (Sildenafil or Tadalafil) for more than 3 months.
Exclusion Criteria
- Underage patients
- Pregnancy or lactation
Data sourced from ClinicalTrials.gov (NCT02484807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.