After years of reports and debate about the extent to which cholesterol-lowering meds can lead to memory loss, the FDA has asked drugmakers to add information about 'non-serious' cognitive side effects to warning labels. At the same time, information is also being added about the possibility that statins can lead to diabetes, citing studies showing an increased risk.
The move may inflame the debate over the extent to which statins should be taken by people who are not at high risk for cardiovascular problems. Just the same, the agency "continues to believe that the cardiovascular benefits of statins outweigh these small increased risks," according to a statement. The drugs include Pfizer's Lipitor and AstraZeneca's Crestor.
Meanwhile, the FDA also removed a requirement for routine monitoring of liver enzymes because liver injury is rare and regular monitoring does not appear to be effective in detecting or preventing serious liver injury. And the labeling for lovastatin, originally marketed as Mevacor by Merck, was extensively updated with new contraindications (here is the FDA statement).
5 Comments
Same question as Van Winkle re: narcos. Do we have any actual numbers (not relative risk) about the glucose?
Very common condition is vascular dementia due to atherosclerotic cerebrovascular disease. Many of these folks are on statins for stroke prevention. If it were my relative in a nursing home and they only had two or three marbles rattling around upstairs, I would still keep them on a statin because the alternative of discontinuing the drug is worse.
OII,
Really? To me the benefits for statins start to look weaker as people become older. At a certain age, the risk of a heart attack starts to be lower than the other types of health risks (among them potential for drug interactions - possibly idiosyncratic). I won't dispute the value for persons who have had an MI or who are young (and male) with high risk factors, but for the elderly, particularly those with some level of cognitive impairment already, I think "less is more" from a pharmacologic perspective.
Makes me nuts to know that many elderly and impaired adults are treated for urinary incontinence AND cognitive impairment at the same time.
Strokes are bad no doubt about it. If family history is any indicator, I will die of a stroke or a pulmonary embolism (or a PE following impaired mobility due to a stroke). However, I'm not signing on for high-dose atorvastatin (where I believe the best data for stroke prevention is).
The other "unknown" is how long does one continue to benefit from the apparent regression of arterial plaques? Consider that many of the people currently in nursing homes will have been treated with one or another statin for the better part of the past 25 years. Certainly, if plaques regress, the stroke and MI lowering benefits would be more durable - asssuming that is actually part of the pathology. If the benefit derives from more of a tissue/antioxidant effect, there are other means to achieve this.
Dr. Helm:
No you should start EACH and EVERY elderly up to age 120 immediately on the highest labeled dose of a statin of your choice. That will help a lot do almost no harm, as seen with cerivastatin.
/sarcasm off
Dr Helm, my apologies for being obtuse. I have a patient, who also happens to be my 85 year old mother (disclaimer) whose recent MRI showed widespread subcortical infarcts in the hippocampal regions of both temporal lobes, which is a contributing factor in her dementia. In fact I prefer the older term multi-infarct dementia to vascular dementia as it is more descriptive. She is currently taking Zocor 40 mg qd. She is currently being worked up for increasingly frequent brief syncopal episodes, which given her history could be secondary to transient ischemic attacks, which, as we know are a prelude to stroke-in-evloution and ultimately completed stroke. She is positive of family history of atherosclerotic cardio and cerebrovascular disease.
Given this additional information, and notwithstanding the family relationship, would you care to revise your recommendation for the use of statins in this patient?