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By AMERICAN COLLEGE OF CARDIOLOGY JUNE 21, 2021
Cognitive decline and dementia are major health concerns in older
individuals, affecting about 10% of people over 60 years old. Statins are used
to reduce low-density lipoprotein cholesterol, or bad cholesterol, thus they
are a fundamental treatment for prevention of primary and secondary
cardiovascular disease (CVD) events. The Food and Drug Administration released
a warning in 2012 about cases of apparent short-term cognitive impairment with
statin use, while acknowledging that the cardiovascular benefits outweigh their
risks.
However, systematic reviews have shown insufficient evidence on
the impact of statins and research has shown mixed results, with some showing a
neurocognitive benefit of statins and others reporting a null effect. According
to the researchers of this study, since statins are widely used among older
adults and expected to increase in use, determining the effects of statin
therapy on cognition in older individuals is vital to help clinicians weigh
their benefits against associated risks.
EDITOR'S NOTE: There also is a new - and contrary study - from the Society of Nuclear Medicine and Molecular Imaging. They say the use of statins for 5 years or more doubles the risk of dementia. This is how science works: researchers study an issue, develop findings and publish them for peer review and challenge. Read the study abstract HERE. - Will Collette
“With statins being increasingly prescribed to older adults, their potential long-term effects on cognitive decline and dementia risk have attracted growing interest,” said Zhen Zhou, PhD, Menzies Institute for Medical Research at the University of Tasmania in Australia and lead author of the study. “The present study adds to previous research by suggesting that statin use at baseline was not associated with subsequent dementia incidence and long-term cognitive decline in older adults.”
Researchers of this study analyzed data from the ASPirin in
Reducing Events in the Elderly (ASPREE) trial. ASPREE was a large prospective,
randomized placebo-controlled trial of daily low-dose aspirin, which included 19,114
participants 65 years old or older with no prior CVD event, dementia or major
physical disability, between 2010 and 2014 from Australia and the U.S. One of
the key selection criteria of ASPREE was that participants had to have a score
of <78 for the Modified Mini-Mental State Examination test, a screening test
for cognitive abilities, at enrollment.
Researchers excluded participants with missing values for cognitive test scores and/or covariates at baseline, resulting in 18,846 participants. They were grouped by their baseline statin use versus non-statin use, with 5,898 (31.3%) of participants taking statins.
The study aimed to
measure outcomes including incident dementia and its subclassifications
(probable Alzheimer’s disease [AD], mixed presentations); MCI and its
subclassifications (MCI consistent with AD, MCI-other); changes in
domain-specific cognition including global cognition, memory, language, and
executive function, and psychomotor speed; and in the composite of these
domains.
After a median of 4.7 years of follow-up, researchers found 566
incident cases of dementia (including probable AD and mixed presentations).
Compared with no statin use, statin use was not associated with risk of
all-cause dementia, probable AD, or mixed presentations of dementia. There were
380 incident cases of MCI found (including MCI consistent with AD and
MCI-other).
Compared to no statin use, statin use was not associated with risk of MCI, MCI consistent with AD or other MCI. There was no statistically significant difference in the change of composite cognition and any individual cognitive domains between statin users versus non-statin users.
Also, no
significant differences were found in any of the outcomes of interest between
users of hydrophilic and lipophilic statins. However, researchers did find
interaction effects between baseline cognitive ability and statin therapy for
all dementia outcomes.
According to the researchers, this study has several limitations, including observational study bias, lack of data on the length of prior use of statins, and the dose of statins was not recorded in the ASPREE trial, so their effects could not be fully explored.
Researchers conclude the study must be
interpreted with caution and will require confirmation by randomized clinical
trials designed to explore the neurocognitive effects of statins in older
populations.
In an accompanying editorial comment, Christie M. Ballantyne, MD,
professor at Baylor College of Medicine in Houston, said the study does have
limitations that the authors address, but agreed the findings suggest statins
do not contribute to cognitive decline.
“Overall, the analysis was well done, and its main strengths are a large cohort with a battery of standardized tests that allowed the investigators to track both cognition and incidence of dementia and its subtypes over time,” Ballantyne said.
“Lingering questions such as the one
raised by this analysis regarding potential adverse effects of statins in
individuals with mildly impaired cognition can only be answered in randomized
controlled trials in the appropriate age group and population and with
appropriate testing and adequate follow-up. In the meantime, practicing
clinicians can have confidence and share with their patients that short-term
lipid lowering therapy in older individuals, including with statins, is
unlikely to have a major impact on cognition.”
Reference: 21 June 2021, Journal of the American College
of Cardiology.
DOI: 10.1016/j.jacc.2021.04.075