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Wednesday, October 23, 2019
NIH-funded clinical trial will test statins in 20,000 older adults.
The National Institute on Aging (NIA) has funded a major study to examine the overall benefits and risks of cholesterol-lowering drugs known as statins in adults age 75 or older without cardiovascular disease. 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. Funding for the trial, called Pragmatic Evaluation of Events and Benefits of Lipid-Lowering in Older Adults (PREVENTABLE), is expected to total $90 million over the next seven years. NIA is part of the National Institutes of Health.
“There has been considerable uncertainty about the benefits and risks of statin use in persons over age 75 years without known cardiovascular disease,” said NIA Director Richard J. Hodes, M.D. “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.”
To date, no large prospective studies have examined whether statin therapy could prevent cardiovascular events specifically in adults older than age 75 who do not have clinical cardiovascular disease. In addition, previous studies enrolled small numbers of people at risk for cognitive impairment so the potential effect of statins on dementia—either preventing or worsening it—could not be established.
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 Susan Zieman, M.D., Ph.D., medical officer in NIA’s Division of Geriatrics and Clinical Gerontology. “The large, diverse study population will also enable us to better evaluate unwanted effects of statins that may put some at risk or reduce their quality of life.”
Four co-principal investigators will lead the PREVENTABLE trial: Karen P. Alexander, M.D. and Adrian Hernandez, M.D. at Duke University Medical Center, Durham, North Carolina; and Jeff D. Williamson, M.D. and Walter T. Ambrosius, Ph.D. at Wake Forest School of Medicine, Winston-Salem, North Carolina.
The trial is funded by NIA grant U19AG065188. Starting in Fiscal Year 2021, the trial will have additional support from the NIH National Heart, Lung, and Blood Institute (NHLBI).
About the National Institute on Aging (NIA): NIA leads the U.S. federal government effort to conduct and support research on aging and the health and well-being of older people. Learn more about age-related cognitive change and neurodegenerative diseases via NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center website. For information about a broad range of aging topics, visit the main NIA website and stay connected.
About the National Heart, Lung, and Blood Institute (NHLBI): NHLBI is the global leader in conducting and supporting research in heart, lung, and blood diseases and sleep disorders that advances scientific knowledge, improves public health, and saves lives. For more information, visit https://www.nhlbi.nih.gov.
About the National Institutes of Health (NIH):
NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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