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In 2012, the FDA issued a safety announcement, noting that statin use might be associated with cognitive impairment such as memory loss or confusion. To evaluate this association, researchers conducted a systematic review and meta-analysis of 57 studies, including 19 randomized controlled trials, in which assessments of cognition among statin users were reported; FDA postmarketing surveillance data also were analyzed.
Moderate-quality evidence suggested no excess risk for dementia or mild cognitive impairment, and low-quality evidence suggested no excess risk for Alzheimer disease. Analysis of postmarketing surveillance data revealed similar cognitive-related adverse-event reporting rates for statins (1.9 per million prescriptions) and two c…