http://link.springer.com/article/10.1007%2Fs11606-014-3115-3
- Brian R. Ott
- , Lori A. Daiello
- , Issa J. Dahabreh
- , Beth A. Springate
- , Kimberly Bixby
- , Manjari Murali
- , Thomas A. Trikalinos
ABSTRACT
BACKGROUND
In 2012, the
United States Food and Drug Administration (FDA) issued a warning
regarding potential adverse effects of HMG-CoA reductase inhibitors
(statins) on cognition, based on the Adverse Events Reporting System and
a review of the medical literature. We aimed to synthesize randomized
clinical trial (RCTs) evidence on the association between statin therapy
and cognitive outcomes.
METHODS
We searched
MEDLINE, EMBASE, and Cochrane CENTRAL through December 2012, and
reviewed published systematic reviews of statin treatment. We sought
RCTs that compared statin treatment versus placebo or standard care, and
reported at least one cognitive outcome (frequency of adverse cognitive
events or measurements using standard neuropsychological cognitive test
scores). Studies reporting sufficient information to calculate effect
sizes were included in meta-analyses. Standardized and unstandardized
mean differences were calculated for continuous outcomes for global
cognition and for pre-specified cognitive domains. The main outcome was
change in cognition measured by neuropsychological tests; an outcome of
secondary interest was the frequency of adverse cognitive events
observed during follow-up.
RESULTS
We identified 25
RCTs (all placebo-controlled) reporting cognitive outcomes in 46,836
subjects, of which 23 RCTs reported cognitive test results in 29,012
participants. Adverse cognitive outcomes attributable to statins were
rarely reported in trials involving cognitively normal or impaired
subjects. Furthermore, meta-analysis of cognitive test data (14 studies;
27,643 participants) failed to show significant adverse effects of
statins on all tests of cognition in either cognitively normal subjects
(standardized mean difference 0.01, 95 % confidence interval, CI, −0.01
to 0.03, p = 0.42) or Alzheimer’s disease subjects (standardized mean difference −0.05, 95 % CI −0.19 to 0.10, p = 0.38).
CONCLUSIONS
Statin therapy was
not associated with cognitive impairment in RCTs. These results raise
questions regarding the continued merit of the FDA warning about
potential adverse effects of statins on cognition.
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