UF Health, OneFlorida join trial to see if statins can help older adults prevent heart disease, dementia

UF Health researchers are enrolling adults ages 75 and older in a clinical trial to see if the cholesterol-lowering drug atorvastatin (Lipitor®) can prevent dementia, disability and heart disease in this age group.  Can taking a statin a day keep heart disease and dementia away in seniors ages 75 and older?

Researchers at University of Florida Health and the OneFlorida Clinical Research Consortium have joined a nationwide clinical trial to find out whether taking atorvastatin (Lipitor®), a drug commonly used to lower cholesterol, can help prevent dementia, disability and heart disease in older adults who haven’t already been diagnosed with those ailments.

The study, expected to become one of the largest clinical trials ever conducted in older adults, will include more than 20,000 participants and 100 sites across the U.S., including UF Health and several other OneFlorida Clinical Research Consortium partner sites.

Recent studies suggest statins may continue to protect the heart and vascular system even after age 75. Preliminary evidence also suggests statins may protect against Alzheimer’s disease and contribute to overall well-being in adults ages 75 and older.

“There’s so much we don’t know about the benefits versus risks of using statins in older people,” said Marco Pahor, M.D., director of UF’s Institute on Aging and UF Health site principal investigator for the PREVENTABLE trial. “The long-term effects of statins on skeletal muscle and the brain are not well documented. PREVENTABLE is designed to address these important questions.”

About one in three people in the U.S. over age 75 without heart disease are taking statins, a class of cholesterol-lowering drugs that are widely prescribed to prevent heart disease among people at high risk in their 50s and 60s.

During the PREVENTABLE study, participants without heart disease and dementia will be randomly assigned to receive either atorvastatin or a placebo that looks like the study drug but has no medicine. Researchers will follow participants for up to five years and test their memory, thinking and physical abilities. Participants will also be monitored for events such as heart attacks or strokes.

This pragmatic study was designed to make research participation easy and efficient. Study visits will be conducted over the telephone and the study drug will be shipped directly to participants’ homes every three months. Study investigators will also monitor participants using electronic health records and Medicare data.

Researchers hope the large size of the study population will help them identify subgroups of older adults who are most likely to benefit from taking statins to prevent dementia, disability or cardiovascular disease. They also hope the large, diverse study population will enable them to evaluate any side effects of statins in this age group.

Duke Clinical Research Institute in Durham, North Carolina serves as the national clinical coordinating center for PREVENTABLE, which is is funded by the National Institute on Aging and the National Heart, Lung, & Blood Institute of the National Institutes of Health under award number U19AG065188.

UF Health serves as the coordinating center for the OneFlorida Clinical Research Consortium, a statewide research network and data trust that includes 12 academic centers and health systems across Florida, some of which will be participating in this clinical trial. OneFlorida’s network of 22 hospitals, 1,240 practices/clinics and 4,100 providers care for about 74% of Floridians in all 67 counties.  OneFlorida is also one of nine clinical research networks nationwide participating in PCORnet, the national patient-centered clinical research network.

To learn more about PREVENTABLE, visit www.preventabletrial.org. To find out more about eligibility for the PREVENTABLE study at UF Health, call the study team at 352-273-5919 or 866-386-7730, or email recruit@aging.ufl.edu.

Media contact: Ken Garcia at kdgarcia@ufl.edu or 352-265-9408.