The value of taking cholesterol-lowering drugs for elderly adults not experiencing cardiovascular disease will be evaluated in a joint $90 million study by Wake Forest Baptist Health and Duke University Medical Center.
The National Institute on Aging will examine the overall benefits and risks of prescribing statins in adults age 75 or older.
It is one of the largest health study grants in Wake Forest School of Medicine history.
In particular, the 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 study will be conducted over seven years. It will be known as Pragmatic Evaluation of Events and Benefits of Lipid-Lowering in Older Adults and the acronym PREVENTABLE.
“This is a major push by the federal government in partnership with places like Wake Forest School of Medicine to start including older people in clinical research and to redesign it so that they can participate more easily,” said Dr. Jeff Williamson, co-principal investigator of the study. Williamson is a professor of gerontology and geriatric medicine in the medical school.
Williamson said study participants will not have to make an office visit, but rather have a trained research assistant come to them to do the physical and cognitive function assessments, and check on their overall health status.
Medications for the study will be shipped directly to their home.
“There has been considerable uncertainty about the benefits and risks of statin use in persons over age 75 years without known cardiovascular disease,” NIA Director Dr. Richard Hodes said.
“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.”
Participants will be enrolled 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, but who may be frail, take multiple medications and have mild cognitive impairment. Each participant will be randomly assigned to take either the statin atorvastatin or a placebo daily for up to five years.
“Because of the large size of this study, we may be able to identify subgroups of older adults most likely to benefit from taking statins to prevent dementia, disability or cardiovascular disease,” said Dr. Susan Zieman, medical officer in NIA’s Division of Geriatrics and Clinical Gerontology.
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