The FDA recently issued a warning that statins could affect memory, attention span and other cognitive abilities of people who are using the drug to control their cholesterol levels. However, a comprehensive review of 25 clinical trials comprising of 47,000 people finds no link between statin use and changes in cognition.
The systematic review was led by Brian R. Ott, M.D., Director of The Alzheimer's Disease & Memory Disorders Center at Rhode Island Hospital and Professor at the Alpert Medical School of Brown University in the U.S and has been published in the Journal of General Internal Medicine.
As per the FDA regulations, labels on statin packaging need to include a warning that the drugs could change users' cognitive abilities. These include attention span, language, and memory, problem solving and visuospatial ability. The warning is based on case reports, surveillance, observational studies and randomised trails.
However, researchers wanted to determine if there was substance to the warning and this recent review casts doubts on the cautionary stance taken by the FDA.
The review found no significant effect of statins on the mental capacity of people with normal brain functioning as well as those with Alzheimer’s disease. These findings are congruent with the safety statement issued by the American College of Cardiology and the American Heart Association Cholesterol Guideline that patients on statins who have memory problems should be evaluated for causes other than their cholesterol medicine.
Based on the findings of this review, there is clearly a need to review the FDA warning. "We found no significant effects of statin treatment on cognition," concludes Ott. "Given these results, it is questionable whether the FDA class warning about potential cognitive adverse effects of statins is still warranted."
The researchers also point out that it is more beneficial for patients to stick to their statin therapy in order to manage heart-related disease and to prevent strokes instead of worrying about the adverse mental effects of these drugs.
Source: Springer Science+Business Media
Image Credit: Wikimedia Commons
References:
Brian R. Ott et. al. 2015. Do Statins Impair Cognition? A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Journal of General Internal Medicine.
