About one in four Americans now takes a cholesterol-lowering statin to reduce the risk of heart disease.
Because of their effectiveness, statin medications are the mainstay of treatment prescribed by doctors for lowering cholesterol, but these drugs are not without side effects.
In 2012, the U.S. Food and Drug Administration (FDA) required that statin labels include a warning about the potential for cognitive side effects. The FDA’s decision was based on reports of memory loss and confusion in some statin users that appeared reversible once the medication was stopped. The caution was based on case reports and small studies, and the evidence was mixed as to whether statins truly create a mental fog.
What the research shows
Now, growing clinical evidence suggests statins may not pose a risk to cognition. The latest findings come from a study presented at the American Heart Association’s annual scientific meeting in November 2016.
In an offshoot of a study of more than 12,000 patients participating in the HOPE-3 (The Heart Outcomes Prevention Evaluation) clinical trial, which examined the use of statins in people with high blood pressure and mild heart disease, no study volunteers reported memory problems after taking a statin medication for five and a half years.
The study was preceded by a report by Johns Hopkins researchers, published in Mayo Clinic Proceedings in 2013, which noted that a systematic review of existing data found no connection between statin use and memory loss or other types of cognitive dysfunction.
The latest study found no negative effect on memory after years of statin use.
Leading heart experts hope the latest evidence will be enough to persuade the FDA to remove the cognitive effects warning from statin labels, a move called for in a review study published in The Lancet in November 2016.
It’s important to note that the results were presented at a conference and have not yet undergone the rigorous peer review process required before a study’s publication to ensure it meets established scientific standards. Also worth noting: The study was funded in part by AstraZeneca, the makers of Crestor, which is the statin that was used in the trial. Still, the data are encouraging.
The heart and brain link
The researchers, led by Jackie Bosch, Ph.D., an associate professor at McMaster University in Canada, were assessing the impact of statins on cognitive and functional decline in older people.
It has been said that “what is good for heart health is also good for brain health,” and the researchers wanted to find out if that maxim truly held when patients took statins on a regular basis. Study participants were placed on one of three regimens: a blood pressure medication, rosuvastatin (Crestor), or both.
To assess cognitive and functional decline, a series of cognitive tests were administered at the start of the study and upon completion. In one test, the volunteers had two minutes in which to substitute a digit that corresponds to a symbol in a certain order. Other tests were of executive function, such as doing everyday banking matters and high-level planning.
After following 1,626 patients 70 and older for an average of six years in 228 centers in 21 countries, and specifically looking to see what impact the statins had on overall cognition, the investigators found that the rate of cognitive decline was exactly the same for all study participants: It made no difference whether the person took a statin, a hypertensive medication, a statin and a hypertension drug, or a placebo. The drugs neither prevented nor worsened cognitive decline among older people at intermediate risk for cardiovascular disease.
Commenting on the issue, Paul Thompson, M.D., director of cardiology at Hartford Hospital in Hartford, Conn., says that memory complaints following statin use are very rare. That complaint alone shouldn’t lessen treatment with statins for people at risk of cardiovascular disease, for whom the benefits of these drugs significantly outweigh their risks, says Thompson, associate editor of the Textbook of Cardiovascular Medicine
“If I have a patient who complains of memory problems after starting a statin drug, I tell them that it’s very unlikely that memory problems are coming from the statin,” says Thompson. “What I will do is stop the drug in patients who complain of a mental fog and see if they get better. I then re-challenge them later by restarting the statin and see what happens.”
More information about the heart-brain link is expected by the end of 2018. That’s when the ongoing SPRINT-MIND (the SPRINT Memory and cognition IN Decreased hypertension) study of 2,800 volunteers is expected to have some results. SPRINT-MIND is testing whether lowering high blood pressure to a new systolic target of 120 mm Hg—as opposed to the now accepted level of 140 mm Hg—will help prevent cognitive decline over the years.