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 US 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, MD, PhD, 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.”