Standardization of outcome measures in clinical trials of pharmacological treatment for abdominal aortic aneurysm.

An abdominal aortic aneurysm (AAA) is a common aortic wall disease with an increased prevalence in the elderly population (4-8% for those aged >65 years). Many AAAs are slow growing and remain insidious. Current standard of care for patients with small AAAs (<49 mm) is surveillance, with interventional therapy (open surgical repair or endovascular aneurysm repair) recommended for large (>50-55 mm), rapidly growing (>10 mm/year) or symptomatic AAAs. Although open surgical repair or endovascular aneurysm repair are effective, significant short- and long-term postoperative morbidity and mortality occurs. Currently, there is no pharmacological treatment specific for AAA; the need for the development of targeted pharmacological therapies based on clinically relevant and feasible outcomes acceptable to the medical community, regulatory agencies and third-party payers is high. A consensus on such end points will be critical to accelerating the development of pharmacological agents to prevent formation, arrest the expansion and reduce the rupture risk of AAA.