Simvastatin 80 mg and FDA warnings; lipids

The FDA recently issued a warning regarding the use of maximum dose simvastatin (80 mg daily).  After a meta-analysis like review of some recent cardiovascular studies, extracted data suggested that this dose of simvastatin was associated with increased muscle irritation (polymyositis and rhabdomyolysis).  The risk was more specifically focused to those who were in the first year of use and/or were using additional medication for lipid control or a calcium channel blocker (diltiazem et al).  We know from prior studies that statins benefit appropriately selected patients without ( West of Scotland study, known vascular disease and with (4S study,  [PDF] from ) known vascular disease.  Going with high dose statin and as low as we can go cholesterol was also deemed beneficial (Prove It study, ).   How do we reconcile this?  The FDA warning implies that if one has been on Simvastatin 80 mg for longer than a year without problems then it can probably be continued safely.  If not, the risks benefits and side effects would need to be reconsidered in follow up.  Please note, the references above are the “classic studies” from their original publication dates.  There has been alot of dialogue on these studies over the years, but these are the papers that have influenced approaches to lipid therapy and heart protection in vascular disease.


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