A Q&A with Dr. Brian Ott, Director, The Alzheimer's Disease & Memory Disorder Center

January 15, 2015

Brian OttRecently published research from Dr. Brian Ott, the director of The Alzheimer’s Disease & Memory Disorders Center at Rhode Island Hospital, found no
link between statin use and changes in the user’s cognitive abilities. These findings dispute a warning issued by the FDA in 2012. The research suggests
those findings should be reevaluated. Ott’s research was published in the Journal of General Internal Medicine and a video interview with Ott can
be viewed here. Below, Ott answers questions about the research.

What was the basis for the FDA warning about statins and their effect on cognition?

On February 28, 2012, the U.S. FDA issued a new warning for the labeling of statin drugs regarding potential adverse effects on cognition. The warning was
based on post marketing surveillance reports, and review of case reports, observational studies, and a few controlled trials. The reports about memory loss
and confusion included all statin products and all age groups. Such experiences were felt to be rare. People reported feeling “fuzzy” or unfocused in their
thinking. In general, the symptoms were not serious and were reversible within a few weeks after the patient stopped using the statin. Some people had been
taking the medicine for a day, while others had been taking it for years.

Why did you take the approach you did in your research – reviewing 25 clinical trials?

While self-reports and unblinded observations can provide valuable information about drug side effects, they run the risk of being biased by such things as
preconceptions about the safety of medications and “placebo” type effects. Self-reports in particular are also vulnerable to effects from improper
medication administration and exaggerated claims. Therefore we felt it was important to look at the most rigorously collected data on these drugs under
placebo-controlled conditions in a large number of patients. To do this, we selected only randomized controlled clinical trials to review, and then
submitted the collected data to a met-analysis in which all of the relevant data could be analyzed as a whole.

How long did this research take?

This was a very labor intensive task requiring a team of researchers that took about one year to complete.

Your research found no significant effects of statin treatment on cognition. What do you hope happens now?

We hope that future post marketing surveillance efforts will focus on critical analysis of effects of re-challenge, as well as factors not addressed in
statin clinical trials, such as effects of very high dosage and compliance with prescribing guidelines. At the present time, our findings, combined with
individual information about dosing and compliance, will allow physicians to more effectively counsel patients about their cognitive health concerns. When
faced with a patient with confusion or memory impairment who is on statin therapy, it is important to evaluate the patient for non-statin causes, such as
exposure to other drugs, as well as for potential systemic and neuropsychiatric causes, and not just assume that the symptoms are due to statin drug
therapy.