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 metaanalyses. 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.

This observational study investigated family caregiver and clinician ratings of 75 drivers with Alzheimer's disease against scores on a standardized road test and a naturalistic driving evaluation. Clinician ratings by a physician specialized in dementia were significantly associated with road test error scores (r 5 .25, p 5 .03) but not naturalistic driving errors or global ratings of road test and naturalistic driving performance. Caregiver ratings were unrelated to either driving assessment, with two exceptions; adult child ratings of driving ability were correlated with road test error scores (r 5 .43, p 5 .02), and spousal ratings were inversely correlated with global ratings. Clinician ratings of driving competence were modestly correlated with road test performance, but caregiver ratings were more complex. Adult children may be more accurate reporters of driving ability than spouses, possibly because of less personal bias, but the reasons behind this discrepancy need further investigation.

OBJECTIVE. To demonstrate that g-force technology can be used to help older adults with cognitive impairment improve their driving safety as part of an in-car video feedback intervention.METHOD. Unsafe driving events triggered g-forces leading to capture of video clips. The program included 3 mo of monitoring without intervention, 3 mo of intervention (weekly written progress reports, a DVD of unsafe driving events, and weekly telephone contacts), and 3 mo of postintervention monitoring.RESULTS. Mean total unsafe driving events per 1,000 miles were reduced from baseline by 38% for 9 of 12 participants during the intervention and by 55% for 7 participants during postintervention monitoring. Mean total unsafe driving severity scores per 1,000 miles were reduced from baseline by 43% during the intervention and by 56% during postintervention monitoring. CONCLUSION.Preliminary results suggest that driving safety among older drivers with cognitive impairment can be improved using a behavior modification approach aimed at problem behaviors detected in their natural driving environment.

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