Dark Side of Statins

HMG coenzyme A reductase inhibitors, commonly known as statins, have become the darling of the medical world in the relatively short amount of time since their introduction due to their ability to reduce LDL-cholesterol (the bad variety) with increasing effectiveness and more importantly, to lower the incidence of heart disease.

However, statins are not without their dark side.  Witness the fiasco that was Baycol, an incredibly efficient drug at lowering cholesterol but deadly when used in combination with gemfibrozil.  Unfortunately, we physicians tend to ignore product insert warnings and sometimes even black box labels such that the FDA pulled Baycol off the market in 2001.

More recently, a commentary was published in the New England Journal of Medicine regarding the increased risk of myopathy & rhabdomyolysis when comparing high dose (80mg) simvastatin to lower doses of the same drug.  And while there has been a movement to chose initial statin doses based upon the required percentage lowering necessary to achieve LDL goals, the FDA is now advising that 80mg of simvastatin no longer be used for initial therapy.  Thus the FDA changed the labeling such that high dose simvastatin should only (continue to) be used in those who've tolerated it for over a year.  In other words, anyone who needs greater LDL lowering than can be achieved w/40mg of simvastatin is advised to use something else to achieve his/her goals.  

In another knock against statins' previously pristine reputation, a meta-analysis of 5 trials was published in JAMA last week concluding that intensive, high dose statins are associated with an increase risk of diabetes.   This finding is consistent with a previous meta-analysis of 13 trials published in Lancet last February.  The point of this post is not to stop using statins but to be aware of their potential side effects.  As always, we need to weigh the risks versus the benefits for each individual.