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Invited Commentary
March 28, 2011

Age-Based Exclusions From Cardiovascular Clinical Trials: Implications for Elderly Individuals (and for All of Us): Comment on “The Persistent Exclusion of Older Patients From Ongoing Clinical Trials Regarding Heart Failure”

Author Affiliations

Author Affiliations: Division of Geriatric Medicine, Department of Medicine (Dr Gurwitz), and Department of Quantitative Health Sciences (Dr Goldberg), The Meyers Primary Care Institute, a joint endeavor of the University of Massachusetts Medical School, Fallon Clinic, and Fallon Community Health Plan, Worcester.

Arch Intern Med. 2011;171(6):557-558. doi:10.1001/archinternmed.2011.33

The exclusion of elderly individuals from cardiovascular clinical trials dates back to the first large randomized clinical trials (RCTs) in the 1960s.1 In 1992, the American College of Cardiology hosted a workshop to consider this issue. In the proceedings, Dr Nanette Wenger wrote, “Not only is cardiovascular disease the major cause of death and disability in aged patients, but also the profile of cardiovascular illness in the United States has shifted to encompass predominantly elderly populations. . . . Yet it is precisely in this population that the traditional exclusion, or at best underrepresentation, of elderly persons in clinical trials has generated an information void.”2(p293) Nearly 2 decades later, as nearly 80 million baby boomers surge into the US geriatric population, the inadequacy of the evidence base to guide the care of older individuals with heart disease remains a problem with few answers.