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

Expert Rev Cardiovasc Ther. 2012 Oct;10(10):1251-60. doi: 10.1586/erc.12.128. Epub 2012 Oct 31.

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.

Publication types

  • Review

MeSH terms

  • Aged
  • Aortic Aneurysm, Abdominal / drug therapy*
  • Aortic Aneurysm, Abdominal / epidemiology
  • Aortic Aneurysm, Abdominal / pathology
  • Aortic Rupture / prevention & control
  • Clinical Trials as Topic / methods*
  • Drug Design
  • Endpoint Determination
  • Humans
  • Molecular Targeted Therapy
  • Outcome Assessment, Health Care / standards*