A Duke cardiologist is playing a key role in a pragmatic trial designed to close a significant evidence gap in the Primary Prevention Guidelines concerning the value of initiating statins in patients 75 or older if not already taking them. A key goal of the trial is to assess the effects of the medication on preventing the future development of dementia.
Existing evidence is insufficient to assess the benefits and harms of initiating a statin for the primary prevention of cardiovascular disease (CVD) and mortality in older adults, according to the 2022 United States Preventative Services Task Force (USPSTF) report. Other conditions associated with aging such as dementia and disability have not been studied in a randomized drug prevention trial.
Addressing this evidence gap is the goal of PREVENTABLE (PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults) trial. PREVENTABLE will be one of the largest studies involving patients aged 75 years or older. The goal is to enroll 20,000 patients; more than 6,000 individuals are already participating.
A team of researchers, clinicians, participant advisors, and community partners are already recruiting patients and completing trial logistics. As part of the randomization, participants will receive by mail a 40-milligram dose of the generic statin atorvastatin or a matching placebo. Follow-up will be undertaken using health records and phone interviews, which will add to the convenience of participation.
“This research will help us answer an important public health question,” says Karen P. Alexander, MD, a Duke cardiologist and a primary investigator (PI) for the trial. “When we are in clinic room talking to an older adult, and they are not on statins, we will be able to answer the question of whether this is a valuable therapy to start at this point in their life.” Patients consistently ask what benefits they can expect and what conditions will this drug help prevent, Alexander says. "Memory is universally valued."
Physicians agree that stains offer valuable secondary prevention for cardiovascular disease and primary prevention for cardiovascular disease in younger adults, but the data on primary prevention for older adults is not as clear, Alexander says. “Answering this question is about the patient’s function and risk factors as much as age, per se. One must consider other possible benefits over the health span.”
PREVENTABLE addresses events that are meaningful for this age group,” Alexander adds. “No one wants dementia or disability,” Alexander says. “We are asking if older adults could live well and be active longer by starting a statin at an older age.
Encourage your patients to enroll
If you are a clinician considering a new statin prescription for primary prevention in your patient 75 years of age or older, we don’t have the best answer at this time. Invite your patient to join this national study, enrolling through 2025. Together, we will answer the primary prevention statin question for older adults by 2027. Go to preventabletrial.org to learn more. Refer patients to participate in Zoom information sessions or contact the study team toll free at 833-385-3899 or at Preventable@dm.duke.edu.