Review challenges FDA warning

Review challenges FDA warning

Do statins cause changes in cognition? In February, the FDA added warnings to statin labels regarding the risk of reversible memory loss and confusion. But a new review from the Journal of the American College of Cardiology reviews the evidence given to the FDA and concludes "that there is no increased risk of cognitive decline" with statin use. The State-of-the-Art Paper was a comprehensive review of case reports, observational research, and randomized, controlled trials of statins and cognitive change, as well as risk of cancer and diabetes. Most of the evidence for cognitive changes came from individual case reports, many of which were self-reported by consumers to the FDA. Observational studies gave mixed results on cognition with four of nine studies showing statins improved cognition, while three showed no change, and two studies found an increased risk of cognitive impairment. The authors suggest that these studies are inconclusive and prone to selection bias. Two large, randomized, controlled clinical trials specifically looked at the effect of statins on cognitive function as the major secondary endpoint. In both, no significant differences were seen between the study and control groups with regard to cognitive decline. Twelve smaller studies showed mixed results with the majority showing no change and only one in 12 showing a detrimental effect of statins on cognitive function, while two studies showed a benefit. Along with lack of evidence to suggest statins lead to cognitive decline, the authors also found no evidence that statins increase the risk of cancer. They did, however, find a small risk for development of diabetes, which they felt was "outweighed by the cardiovascular benefits in patients for whom statin therapy is recommended" (J Am Coll Cardiol published online August 15, 2012).