Should people start taking statins after age 70 even if they have never had a heart attack or stroke? A major study published over the weekend in the New England Journal of Medicine provides important new evidence on a question that has long lacked the level of data doctors might expect for drugs used so widely.
In the Australian STAREE trial, treatment with atorvastatin reduced the relative risk of a major cardiovascular event by 30% among adults aged 70 and older who had no known cardiovascular disease. The study was a randomized, double-blind, placebo-controlled trial, considered one of the most reliable ways to determine whether a medical treatment actually causes an observed effect.
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Statin treatment reduced the relative risk of a cardiovascular event by 30%
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The 9,971 participants, whose average age was about 75, were living independently and had no clinical cardiovascular disease, diabetes or dementia when the study began. Their average LDL cholesterol level was about 126 mg/dL. Half received 40 mg of atorvastatin daily, while the rest received a placebo. Median follow-up was 5.9 years.
Atorvastatin belongs to the statin family of drugs, which lower LDL cholesterol, often referred to as “bad” cholesterol. Over time, elevated LDL contributes to the buildup of fatty deposits in artery walls and the development of atherosclerosis, increasing the risk of heart attack and stroke.
The trial’s main cardiovascular result was significant. A cardiovascular event, defined as cardiovascular death, nonfatal heart attack, stroke or the need for a procedure or surgery to reopen coronary arteries, occurred in 6% of participants taking atorvastatin, compared with 8.3% of those receiving placebo. That translated into a 30% relative reduction in risk.
Prof. Eyal Ben Assa, director of the interventional cardiology and catheterization unit at Assuta Ashdod University Hospital, said the population included in the trial is what makes the findings particularly important.
“This is an important population of older adults, all over 70,” he said. “It’s a very large study, involving nearly 10,000 people who had no diabetes, dementia or known heart disease, and whose average LDL levels were not particularly high. Yet atorvastatin still produced a substantial reduction in cardiovascular events.”
Could this change treatment?
The question of prescribing statins at an older age is particularly complicated when they are being considered for primary prevention, meaning for someone who has never had a heart attack, stroke or another cardiovascular event. That differs from secondary prevention, in which statins are used in people who have already experienced such an event and are known to face a higher risk of another.
“I think this changes the way I treat patients,” Prof. Ben Assa said. “I now have strong scientific support for starting statins for primary prevention. I would not withhold treatment simply because a patient is over 70. I also think this study will change the approach of many physicians, especially because until now we simply did not have enough evidence.”
Prof. Eyal Ben AssaPhoto: Assuta AshdodStill, he stressed that the findings do not mean everyone over 70 should automatically receive a statin. “I would not look at an active, independent 75-year-old who has several other cardiovascular risk factors in the same way as an 80-year-old who is bedridden and does not move,” he said.
“The findings have to be considered in the right context. I will look at cholesterol, other risk factors, the risk of developing cardiovascular disease, whether imaging shows atherosclerosis and whether there is a family history of cardiovascular events. Treatment has to be tailored to each patient.”
While STAREE produced a significant result for its primary cardiovascular outcome, it did not prove a benefit for its secondary objective. Researchers also examined whether statin treatment would extend “disability-free survival,” a combined measure that included death from any cause, development of dementia or persistent physical disability.
That outcome occurred in 12.8% of those receiving atorvastatin and 13.6% of those receiving placebo, a difference that was not statistically significant. The trial also did not find a significant reduction in dementia itself.
“That needs to be taken into account,” Prof. Ben Assa said. “The combined outcome of death, dementia and disability did not decline significantly, and the study did not reduce overall mortality. But it did clearly reduce heart attacks and catheterization procedures, as well as the broader outcome that included stroke and cardiovascular death. A 30% relative reduction is significant.”
A separate signal on dementia
The question of dementia received additional attention over the weekend from a separate study presented at the European Society of Cardiology’s annual congress in Munich and published in The Lancet Regional Health – Europe.
That study examined whether the timing of statin treatment was associated with dementia risk among people with type 2 diabetes. Unlike STAREE, it was not a randomized trial in which researchers determined who would receive treatment. Instead, it was an observational study based on Denmark’s national health registries.
A drug used to lower LDL cholesterol
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Researchers identified 132,585 people diagnosed with type 2 diabetes between 2006 and 2019 who had not been taking statins before their diagnosis. They compared people who started statins within one year, those who began treatment between one and five years after diagnosis and those who did not start taking statins during the first five years. Median follow-up was 7.1 years, during which 2.7% of participants developed dementia.
Those who began taking statins within the first year after their diabetes diagnosis had a 15% lower relative risk of developing dementia over 10 years compared with those who did not begin treatment. Starting statins between one and five years after diagnosis was associated with a 10% lower risk. The results were similar among men and women.
The finding is notable because statins have previously faced claims that they could contribute to dementia. In this study, dementia was instead less common among statin users.
But the distinction between the two studies is critical. Because STAREE was randomized, researchers can be much more confident that the reduction in cardiovascular events resulted from the treatment itself. The Danish study, by contrast, can demonstrate only an association.
Even after statistical adjustments aimed at reducing differences between the groups, researchers cannot rule out the possibility that people who start statins early differ in other ways from those who do not take them, and that those differences influence dementia risk. The researchers themselves stressed that the findings do not prove statins prevent dementia.
Prof. Ben Assa also said it is important to distinguish between different forms of dementia. “There are many causes of dementia,” he said. “There are types such as Alzheimer’s disease that are not necessarily related to atherosclerosis, but there is also vascular dementia, which is linked to small strokes that accumulate over time and cause cognitive decline and dementia. That is connected to cerebrovascular events and blood vessels.”
Statins may help support brain health
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That, he said, could help explain a possible indirect benefit of statins for brain health. “Just as statins reduce atherosclerosis and the risk of cardiovascular events, including stroke, they may offer benefits here as well,” he said. “I would not prescribe statins specifically to prevent dementia, but I would use them to prevent cerebrovascular events that could contribute to or worsen dementia. And I certainly would not avoid starting statins out of concern that they might worsen dementia.”
The takeaway from the two studies is not that every older adult should start taking a statin, nor that statins should now be used to prevent dementia. But STAREE provides important randomized evidence that in independent adults aged 70 and older with no known cardiovascular disease, atorvastatin can significantly reduce the risk of a first major cardiovascular event.
The Danish study, meanwhile, suggests that starting statin treatment earlier may also be linked to better long-term brain health, though that association still requires further study.
“It is better to prevent an event than to treat it after it happens,” Prof. Ben Assa said. “For people over 70, especially those who are independent and active, this study gives us much greater confidence in using statins for primary prevention.”
The information in this article is not a recommendation for treatment and is not a substitute for individualized medical or professional advice and care