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New analysis finds no association between statins, cognitive impairment
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A systematic review and meta-analysis of 25 randomized controlled trials yielded no significant association between statin therapy and cognitive impairment.
This finding conflicts with an FDA warning issued in 2012 regarding potential adverse effects of statins on cognition, which was based on feedback from the Adverse Events Reporting System and a literature review, according to the study background.
“Given these results, it is questionable whether the FDA class warning about potential cognitive adverse effects of statins is still warranted,” Brian R. Ott, MD, director of the Alzheimer’s Disease and Memory Disorders Center at Rhode Island Hospital and professor of neurology at Alpert Medical School at Brown University, said in a press release.
Ott and colleagues identified 25 placebo-controlled, randomized controlled trials published by December 2012 that reported cognitive outcomes (n=46,836). Of those, 23 trials reported cognitive test results (n=29,012).
According to the results, adverse cognitive outcomes attributable to statin therapy were rarely reported, whether the trials involved individuals with normal or impaired cognition.
A meta-analysis of cognitive test data from 27,643 participants in 14 studies also showed no significant adverse events of statin therapy on all tests of cognition, both in participants with normal cognition (standardized mean difference, 0.01; 95% CI, –0.01 to 0.03) and those with Alzheimer’s disease (standardized mean difference, –0.05; 95% CI, –0.19 to 0.1).
For cognitive domains such as memory, which had a large sample size, confidence intervals were narrow and excluded even very small differences. However, for domains such as working memory, which had limited data, confidence intervals were wide; thus, large beneficial or harmful effects could not be excluded, according to the researchers.
“In terms of an overall signal, however, our analysis of [standardized mean differences] for all cognitive outcomes do not confirm the signal detected from spontaneous adverse event reports. … The risks for cognition, if any, are likely outweighed by the beneficial effects of adherence to statin therapy on [CV] and cerebrovascular disease,” they wrote.
Disclosure: The study was supported in part by a grant from the Agency for Healthcare Research and Quality. Ott reports receiving grant support from Avid, Baxter, Eli Lilly, Janssen Pharmaceuticals, Merck, Pfizer, Roche and TauRx, and consultant support from Accera.
Perspective
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Joseph S. Alpert, MD, MACP
There is very solid evidence from cell cultures of central nervous system neurons that statins impair their function. In addition, selected patients have a real cognitive problem, particularly with recent memory, when they take statins. It is not severe, and statins are certainly safe in the vast majority of individuals, as noted in the meta-analysis. Nevertheless, there are case reports and letters to journals reporting individuals with cognitive impairment during statin administration. On balance, the benefit of statins far outweighs this small cognitive problem. I have seen an occasional patient that could not tolerate statins because of mental ‘cloudiness.’
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