Jonathan Golledge
Nationality
Australia
Current Position
Director of the Vascular Biology Unit
Organization
James Cook University
Research Forum Session

Topic: Randomised-controlled trial testing the efficacy of telmisartan to slow growth of small abdominal aortic aneurysms

Abstract

Objective: The TElmisartan in the management of abDominal aortic aneurYsm (TEDY) trial tested the efficacy of the angiotensin receptor blocker telmisartan in slowing AAA growth. Design: Randomized controlled trial. Setting, participants and intervention: Participants with 35-49 mm AAAs recruited from Australia, the Netherlands and the USA were randomly allocated 1:1 to 40 mg telmisartan or identical placebo. Main outcomes: The primary outcome of the difference in AAA growth assessed on core imaging laboratory read ultrasound was tested with linear mixed effects models. Other outcomes included effects on blood pressure, computed tomography (CT)-measured AAA diameter and volume, time to AAA-related events (AAA repair or mortality from AAA rupture) and health-related quality of life. Results: 210 participants were enrolled and randomly allocated to telmisartan (n=107) or placebo (n=103). Major reasons for pre-screen failure included already prescribed an angiotensin converting enzyme inhibitor or angiotensin receptor blocker, AAA diameter not within entry range, declined involvement or renal or liver dysfunction. Blood pressure was lower in participants’ allocated telmisartan compared to placebo (p<0.001 at one year). 188 (91%) participants attended at least two ultrasound scans and 133 (64%) had a least two CT scans. There was no significant difference in ultrasound-assessed AAA growth rates among those assigned telmisartan (1.68 mm/year) or placebo (1.78 mm/year): mean difference -0.11 mm/year (95% CI -0.60 to 0.38; p=0.66). Telmisartan had no significant effects on AAA growth assessed by CT-measured AAA diameter (p=0.23) or volume (p=0.11), or on AAA-related events (p=0.52) or health-related quality of life. Hypotensive symptoms were twice as common among participants taking telmisartan compared with placebo (26% vs 13%; p=0.02), but overall adverse event rates were otherwise similar for both groups. Conclusion This trial did not show a treatment effect for telmisartan on small AAA growth.

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