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Randomized clinical trial of mast cell inhibition in patients with a medium-sized abdominal aortic aneurysm
H Sillesen1, N Eldrup2, R Hultgren3
1Department of Vascular Surgery, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Background:
Abdominal aortic aneurysm (AAA) is thought to develop as a result of inflammatory processes in the aortic wall. In particular, mast cells are believed to play a central role. The AORTA trial was undertaken to investigate whether the mast cell inhibitor, pemirolast, could retard the growth of medium-sized AAAs. In preclinical and clinical trials, pemirolast has been shown to inhibit antigen-induced allergic reactions.
Methods:
Inclusion criteria for the trial were patients with an AAA of 39-49 mm in diameter on ultrasound imaging. Among exclusion criteria were previous aortic surgery, diabetes mellitus, and severe concomitant disease with a life expectancy of less than 2 years. Included patients were treated with 10, 25 or 40 mg pemirolast, or matching placebo for 52 weeks. The primary endpoint was change in aortic diameter as measured from leading edge adventitia at the anterior wall to leading edge adventitia at the posterior wall in systole. All ultrasound scans were read in a central imaging laboratory.
Results:
Some 326 patients (mean age 70·8 years; 88·0 per cent men) were included in the trial. The overall mean growth rate was 2·42 mm during the 12-month study. There was no statistically significant difference in growth between patients receiving placebo and those in the three dose groups of pemirolast. Similarly, there were no differences in adverse events.
Conclusion:
Treatment with pemirolast did not retard the growth of medium-sized AAAs.
Registration Number:
NCT01354184 (https://www.clinicaltrials.gov).
Insights
Pemirolast, a mast cell inhibitor, did not slow the growth of medium-sized abdominal aortic aneurysms (AAAs) in a clinical trial. This study found no significant difference in AAA growth rates between patients receiving pemirolast and those on placebo.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Inflammation Research
Background:
- Abdominal aortic aneurysm (AAA) pathogenesis involves inflammatory processes in the aortic wall, with mast cells playing a key role.
- Pemirolast is a mast cell inhibitor investigated for its potential to mitigate AAA progression.
Purpose of the Study:
- To evaluate the efficacy of pemirolast in retarding the growth of medium-sized abdominal aortic aneurysms (AAAs).
Main Methods:
- The AORTA trial included 326 patients with AAAs (39-49 mm diameter) treated with pemirolast (10, 25, or 40 mg) or placebo for 52 weeks.
- The primary endpoint was the change in aortic diameter measured by ultrasound; exclusion criteria included prior aortic surgery and diabetes.
Main Results:
- The mean AAA growth rate was 2.42 mm over 12 months, with no statistically significant difference observed between pemirolast treatment groups and the placebo group.
- No significant differences in adverse events were reported across the treatment arms.
Conclusions:
- Pemirolast treatment did not demonstrate a statistically significant effect in retarding the growth of medium-sized abdominal aortic aneurysms.
- Further research may be needed to explore other therapeutic targets for AAA management.
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