The National Institute on Aging (NIA) has funded a major study by a North Carolina initiative including Wake Forest School of Medicine and Duke University Medical Center to investigate overall benefits and risks of cholesterol-lowering drugs knowns as statins in adults age 85 or older without cardiovascular disease. This trial will help determine whether a statin can help prevent dementia and disability in this age group, as well as heart attacks and other cardiovascular-related deaths, while not increasing risks of adverse health outcomes. The sponsors and investigators will tap into the U.S Department of VA and the National Patient-Centered Clinical Research Network for participants and associated records.
Inclusion of the Elderly in Research
The federal government seeks to increasingly include the elderly in clinical research reported Jeff Williamson, MD, co-principal investigator of the study and professor of gerontology and geriatric medicine at Wake Forest School of Medicine (part of Wake Forest Baptist Health). This “patient-centric” study will include at-home features—for example research assistants will visit the participant’s homes for monitoring.
What is the Point of PREVENTABLE Study?
The Pragmatic Evaluation of Events and Benefits of Lipid-Lowering in Older Adults PREVENTABLE) study seeks to investigate overall benefits and risks of use of statins in the elderly without cardiovascular disease. Funder NIA’s Director, Richard J. Hodes, MD posits that “there has been considerable uncertainty about the benefits and risk of statin use in persons over 75 years without cardiovascular disease.” Dr. Hodes continued “This large trial with older adults in real-world clinical settings will provide the opportunity to further our knowledge and better inform treatment decisions for older adults.”
And the Wake Forest-originated press release revealed that to date there have been no large prospective studies assessing whether statin therapy could prevent cardiovascular events specifically in adults over 75 who don’t have cardiovascular disease. Moreover, previous studies enrolled small numbers of participants at risk for cognitive impairment so the possible side effects of statins on dementia—either good or bad—couldn’t be established.
The investigator/sponsors will enroll participants from 60 hospitals and 40 health care systems that are part of clinical trial networks supported by the U.S. Department of Veterans Affairs and the National Patient-Centered Clinical Research Network. The investigators will enroll 20,000 participants without signs of heart disease who may be frail, take multiple medications and have mild cognitive impairment. Each participant will be randomly assigned to take either the statin atorvastatin (Lipitor) or a placebo daily for up to five years.
Jeff Williamson, MD, co-principal investigator of the study and professor of gerontology and geriatric medicine at Wake Forest School of Medicine
Walter T. Ambrosius, Ph.D., chair of biostatistics and data science, Wake Forest School of Medicine
Karen P. Alexander, MD Duke
Adrian Hernandez, MD Duke
Call to Action: Are statins useful to help prevent cardiovascular events? Track this study to find out. We will.