Hypotensive Events Associated With PDE-5 Inhibitors in Pulmonary Arterial Hypertension: Assessment of the USFDA Adverse Event Reporting System Using Disproportionality and Interaction Analysis - PubMe
4 hours ago
- #pulmonary arterial hypertension
- #PDE-5 inhibitors
- #drug safety
- PDE-5 inhibitors are key in treating pulmonary arterial hypertension, often combined with other drugs, but hypotension risks with combinations are not well-defined.
- Analysis of FAERS data from 2004 to 2024 used statistical methods to assess hypotension signals; among over 29 million reports, 704 PDE-5 inhibitor-related hypotension cases were found (533 monotherapy, 171 combination).
- No significant hypotension signals were detected with PDE-5 inhibitor monotherapy, but combinations with endothelin antagonists (like bosentan) and prostacyclin analogs (e.g., epoprostenol) showed strong safety alerts.
- Interaction scores indicated significant interactions between sildenafil/tadalafil and endothelin antagonists, highlighting potential drug interaction risks.
- Paradoxically, monotherapy was linked to higher death and life-threatening event rates despite fewer hypotension reports, suggesting combination therapy events may be more manageable.
- The findings stress the need for close monitoring and personalized risk assessment in PAH patients on PDE-5 inhibitor therapies, especially in combinations.