title: Standardization of outcome measures in clinical trials of pharmacological treatment for abdominal aortic aneurysm.
abstract: 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.
authors.affiliation: Cardiovascular Science Unit, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. xingli.wang@novartis.com
authors.forename: Xing Li
authors.initials: XL
authors.lastname: Wang
authors.forename: Matt M
authors.initials: MM
authors.lastname: Thompson
authors.forename: William P
authors.initials: WP
authors.lastname: Dole
authors.forename: Ronald L
authors.initials: RL
authors.lastname: Dalman
authors.forename: Andrew
authors.initials: A
authors.lastname: Zalewski
mesh_terms: D000368:Aged; D017544:Aortic Aneurysm, Abdominal / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D001019:Aortic Rupture / Q000517:prevention & control; D002986:Clinical Trials as Topic / Q000379:methods*; D015195:Drug Design; D023381:Endpoint Determination; D006801:Humans; D058990:Molecular Targeted Therapy; D017063:Outcome Assessment, Health Care / Q000592:standards*