UHealth researchers are recruiting volunteers to study the impact of statins on dementia risk.
As the Chief of General Internal Medicine at the University of Miami Health System, Olveen Carrasquillo, M.D., M.P.H., faces a dilemma. “The top concern I hear from my elderly patients is, ‘What can I do to prevent dementia?’ Right now, I tell them, ‘Eat a balanced diet, exercise, and do crossword puzzles.’ If there was a study showing that cholesterol-lowering medications help prevent dementia, it could address this major concern of older people.”
Some small-scale studies seem to indicate that statins prevent cognitive decline after age 75, he says. A larger, randomized study is necessary to determine if lowering cholesterol near the brain reduces stress on that organ. Theoretically, the brain would be healthier and mental decline would be less likely if blood pressure is lower.
Dr. Carrasquillo hopes older South Florida residents will help him and other researchers find answers to the dementia dilemma. UHealth is a part of the five-year, nationwide PREVENTABLE study evaluating the effects of the lipid-lowering medication atorvastatin (Lipitor) on age-related diseases and longevity. Statin drugs are commonly prescribed to lower cholesterol and the risk of heart attack and stroke. The new study hopes to show that statins also help reduce the risk of dementia. The research might also help doctors determine whether taking statins after 75 is necessary for people who don’t have heart disease. About one in three older adults take statins, even though they don’t have heart disease.
Volunteers are needed
Researchers want to enroll more than 20,000 older adults at 100 sites throughout the country. Just as volunteers were critical to the COVID-19 vaccine effort, Dr. Carrasquillo says the same is true for dementia. “We need a lot of volunteers to help us answer key questions. It’s the only way we advance medical science.” He is recruiting volunteers in Miami-Dade, Broward, and Palm Beach Counties.
Veterans who meet the study criteria are also encouraged to volunteer. The VA PREVENTABLE Network, a group of Veterans Administration (V.A.) medical centers across the country, is partnering in this trial with more than 50 participating enrollment sites. If you are a veteran living in South Florida and interested in learning more about this trial at the Miami VA Healthcare System, please email Jennifer Denizard, RN, BSN, or call 305-575-7000 ext.13961.
Here’s how the study works:
- Participants take either atorvastatin or a placebo for five years. Medication is mailed to the participant’s home.
- Participants are monitored for heart attack and stroke.
The National Institute on Aging and the National Heart Lung Blood Institute funded the study. Both agencies are part of the National Institutes of Health.
To qualify for the study, people must meet five criteria:
- Be 75 or older
- No previous or current statin use
- No history of heart disease
- No history of dementia
- No significant disability
Why is this study important?
“Statin use is well established among adults with cardiovascular disease and those at high risk for related health problems. However, we don’t know how these medications may benefit adults older than age without 75 heart disease or how they may protect the brain from sub-clinical vascular disease,” says Dr. Carrasquillo. The PREVENTABLE study will evaluate the drug’s effect on the brain and physical function. The study is important because there are very few clinical trials involving people over 75. Additionally, not many people in that age group were ever evaluated for the risks and benefits of statins during the drug’s early trials.
The most critical purpose of this study underscores Dr. Carrasquillo’s point. “We don’t have any good treatment for dementia. Statins may be another way to approach the disease.”
Finding older volunteers who aren’t already taking statins is a challenge. “Most doctors prescribe statins for elderly patients, especially at UHealth, where we treat a lot of co-morbidities,” Dr. Carrasquillo says. He feels that UHealth’s success in recruiting participants is especially valuable. “We have a degree of diversity and ethnicity in South Florida that is hard to replicate in other parts of the country.”
Risks vs. benefits
There’s a small risk that taking statins could increase blood sugar levels, causing some people to develop pre-diabetes or diabetes. In some instances, statins increase liver enzymes, causing inflammation in the liver. Regular blood tests monitor for this condition, and if it does occur, most people can continue taking statins by switching medications. In a few people, the drug causes muscle pain, but Dr. Carrasquillo says this usually subsides. “If you are having muscle pain due to statins, you should talk to your doctor about it. Doctors may try lowering your dose, switch you to a different kind of statin, and some may even try alternative medicine approaches such as recommending a coenzyme Q10 supplement.” Some reports suggest statins may negatively affect memory and cognitive decline. Hopefully, the PREVENTABLE study will demonstrate the opposite effect. “Compared to the side effect profiles of most medications, statins are safe. The side effects are so minimal, at one point, it was thought that statins might become over the counter medication.”
Like many physicians, Dr. Carrasquillo believes the benefits of statins outweigh the risks. He cites a Veterans Health Administration study stating that among 326,981 U.S. veterans whose average age was 81, statin use was associated with 25% fewer deaths overall and 20% fewer cardiovascular deaths during a seven-year follow-up period. Another study showed that statins might help fight cancer. For Dr. Carrasquillo and his fellow researchers, being able to prove that statins also help prevent dementia would be a significant medical victory.
Nancy Moreland is a regular contributor to UMiami Health News. She has written for several major health care systems and the CDC. Her writing also appears in the Chicago Tribune and U.S. News & World Report.
For more on clinical trials that are currently underway at UHealth, visit UMiamiHealthResearch.org.
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