Crestor via Wikipedia
Do statins like Lipitor, Zocor, and Crestor make people confused? And, if so, how often do they do it?
Short answer: they seem to, but not nearly as often as neurological or psychiatric side effects occur through no fault of the drug. The Food and Drug Administration just decided to add cautionary language to the labeling of these popular statin lowering drugs, which are taken by 20 million Americans, according to IMS Health.
Given the new FDA notice, it seems worth going back to the most recent data to show that a statin had mental side effects: the 17,802-patient study of Crestor called JUPITER. This study showed that Crestor, made by AstraZeneca, reduced the risk of a major cardiovascular event (that includes heart attack, stroke, hospitalization, and surgery to open clogged arteries) by 44%. In these people, the risk of a heart problem during the course of the study was low: 142 of 8,901 patients on Crestor had a major cardiovascular event during the course of the study, compared to 252 of the 8,901 patients taking placebo.
The issues of cognitive side effects were made public in briefing documents provided by the FDA to a panel of experts who voted on whether Crestor should be approved for preventing heart attacks, strokes, and heart procedures in patients who had never had one. You can read them here. Overall, 69 of the 8,901 patients taking Crestor reported "nervous system disorder" compared to 76 on placebo; 515 Crestor patients reported psychiatric issues, including insomnia and depression, compared to 533 on placebo.
The evidence for confused state comes up here:
The Applicant reported that 18 rosuvastatin-treated subjects versus 4 placebo-treated subjects experienced the AE of “confusional state”. Six of the 18 confusional states in rosuvastatin-treated subjects were considered as a SAE. Two subjects were not on study medication at the time and others had concurrent medical conditions and/or medications ongoing at the time of the event
So 18 patients out of a total of 8,901 reported having a confused state quadruple the number on placebo. (Two of the patients were not taking drug when the confusional state happened, but normally they'd be included in a safety analysis anyway to be conservative.) So although we're talking about quadrupling of risk of becoming extremely confused, Crestor would have only caused this side effect in 0.16% of patients.
But about 600, or 7%, of patients reported neurologic and psychiatric side effects while on Crestor in this same clinical trial. That means that for ever person in this trial whose confusional state was caused by Crestor, another 43 had neurological or psychiatric side effects that were probably not due to the drug.
I think all of these side effects are probably under-reported, and I think that doctors are probably too fast to shrug off cases of muscle pain or memory issues that might be the result of statin therapy. It's also important to note that the FDA's decision was probably based on a lot more than this analysis. But this shows pretty clearly why this poses a difficult situation for doctors and patients: a particular case of fogginess or forgetfulness is probably not caused by the drug -- except in the rare cases where it is.
