Representation of Older Adults in the Late-Breaking Clinical Trials American Heart Association 2011 Scientific Sessions

American College of Cardiology Foundation: August 2012

Increasingly, the practice of medicine has relied on applicable and available evidence to deliver quality care. Cardiovascular medicine has led the way using numerous clinical trials as the basis of clinical practice guidelines. However, despite the strong association of aging with the development of cardiovascular disease, randomized clinical trials rarely enroll a substantial proportion of older adults, leading experts to question the applicability of the evidence base to the typical patient with cardiovascular disease (1). We sought to document the inclusion of older adults in contemporary high-profile, recently conducted clinical trial populations in cardiovascular disease and compare the age characteristics of the clinical trials with the age characteristics of the diseases being studied.

All late-breaking clinical trials (LBCTs) at the 2011 American Heart Association (AHA) Scientific Sessions were included in this study (2). For each LBCT, a brief summary of the important results, with all available age information, was extracted. This represented inclusion or exclusion characteristics on the basis of age and the age information of the baseline characteristic (means, medians, and proportions above and below age cut points). The LBCTs were divided into disease-based categories, and results were tabulated by category. When available, the published report for each LBCT was used. In cases in which the reports were not published, information was obtained from the LBCT slide set on the AHA Web site (2) and supplemented with information from ClinicalTrials.gov as needed. To compare the clinical trial cohort with the community population, the prevalence of older adults in each disease category was ascertained. Read more