A new observational study shows that statins, the first-line cholesterol-lowering drugs known for preventing heart attacks and strokes, are not associated with an increased risk of dementia, mild cognitive impairment, or changes in cognition in initially healthy older adults.
Researchers analysed data from 18,846 participants enrolled in the ASPREE trial (87% participants were from Australia and 13% from the U.S.).
They found no statistically significant differences between statin users and non-users across all neurocognitive outcomes examined in the ASPREE trial, including onset of dementia, mild cognitive impairment, or changes in cognitive ability.
Over an average of 4.7 years, 3.1% (184 of 5,898) of ASPREE participants who were taking statins at enrolment and 3.0% (382 of 12,948) of participants who were not taking statins at enrolment, developed dementia.
Similarly, cases of mild cognitive impairment were recorded in 2.0% (118 of 5,898) of statin users and in 2.0% (262 of 12,948) of statin non-users.
The researchers also found no difference in neurocognitive outcomes between participants taking different types of statins.
Lead author, Dr Lucy Zhou said only a randomised controlled trial would provide evidence of the benefits and risks of statins in older adults.
ASPREE participants, who were mostly 70 years of age or older, had no known cardiovascular disease events, dementia, or major physical disability at enrolment into the trial.
Lead author, Dr Lucy Zhou said while the findings were reassuring to senior statin users, only a randomised controlled trial would provide evidence of the benefits and risks of statins.
“Our study did not find any evident impact of statin therapy on cognition and dementia risk in older adults, however, we must recognise that this study is observational, and statins were not randomised by study investigators,” said Dr Zhou.
Senior co-author, general practitioner and ASPREE Chief Investigator, Professor Mark Nelson agreed.
“These findings are reassuring for older adults and their clinicians with concerns as to statin safety and potential adverse cognitive effect of statins. However, the data should not be over-interpreted, and we should stay tuned,” said Prof Nelson.
“Randomised controlled trials designed to investigate the neurocognitive effect of statin in an exclusive older population, such as the STAREE trial, will provide the definitive answer,” he said.
Results from the Monash University-led STAREE (Statins in Reducing Events in the Elderly), trial are projected to be available in 2025.
The paper was published online in the Journal of American College of Cardiology, with an accompanying editorial.