Aortic & peripheral vascular diseaseRandomised controlled trial
Efficacy of Irbesartan in Celiprolol-Treated Patients With Vascular Ehlers-Danlos Syndrome
- Randomised controlled trial
- multicentre
- placebo-controlled
Authors' conclusion
Compared with placebo, irbesartan reduced the risk of severe symptomatic and asymptomatic arterial events in patients with vascular Ehlers-Danlos syndrome on background celiprolol therapy.
Study context
- Population
- Adults with vascular Ehlers-Danlos syndrome on stable background celiprolol
- Participants
- 29 vs 28
- Comparison
- Irbesartan vs placebo on background celiprolol
- Irbesartann = 29
- Placebon = 28reference
- Primary endpoint
- Composite of vascular Ehlers-Danlos syndrome-related fatal or nonfatal arterial event or new or worsening arterial lesions on CT angiography or duplex ultrasound (time-to-first-event)
- Follow-up
- 2 years
Primary result
As reported in the abstract
Hazard ratio
0.42
95% CI 0.17–0.99
P < 0.05
Events by treatment group
Irbesartan vs Placebo
HR 0.42 (95% CI 0.17–0.99); P < 0.05
Further findings
| Outcome | RR (95% CI) | P value | |
|---|---|---|---|
| Recurrent symptomatic or nonsymptomatic arterial events | 0.37 (0.19–0.68) | P = 0.002 | |
| 0.20.5125Relative risk (log scale) |
| Outcome | baseline-adjusted difference (mm Hg) | P value |
|---|---|---|
| SBP | 5.4 | P < 0.001 |
- SBP: reduction with irbesartan; no relation with reduction of primary outcome
Progression of arterial lesions
- Reduction of progression observed at all sites
Safety
Irbesartan-related hypotension
- Episodes of hypotension
- 11
- Patients with downtitration
- 4
Original publication
Efficacy of Irbesartan in Celiprolol-Treated Patients With Vascular Ehlers-Danlos Syndrome. Circulation. Published 5 February 2025. doi:10.1161/circulationaha.124.072849
Summarised from the published abstract; every number is checked against it