The Simvastatin Story

This week the FDA released new guidelines in regards to the use of the very common medication, simvastatin, which is used to lower cholesterol and thereby decreasing the risk of heart attack and stroke.  The reason for the guidelines change was due to new information that has been received from their Adverse Event Reporting System.  They found that there was an increased incidence of problems with muscles at the highest dose, 80 mg.  The incidence for this was much higher during the first year that a patient took the drug and was much more so in combination with certain other medications.  The most common are the calcium channel blockers used to control high blood pressure (diltiazem, verapamil).  They recommend that no more than 20 mg of simvastatin be taken in combination with these drugs and 20 mg with a similar medication, amlodipine.

Simvastatin 80 mg pill

You may ask, if there are serious risks to taking this medication, why wasn't it just pulled off of the market?  The reason is that for many people the risk of not taking the medication is higher than the risk of taking it.  In the last twenty five years, the incidence of heart disease has decreased dramatically.  Most researchers feel that it is due to the beneficial effects of the statin medications.  Their effects on the liver and on muscle tissue is well known.  When it is watched for and monitored, the medication is safe.  Simvastatin in particular is useful because it is the only statin on the market that is both potent and available in a generic form.  In my opnion, lovastatin and fluvastatin have more incidence of muscle pains.  Pravastatin is quite safe, has fewer muscle problems but is not very potent.  Basically, three options remain: Crestor, Lipitor and Vytorin.  Crestor and Lipitor will both be quite a bit more expensive.  The incidence of muscle problems is likely to be lower but the potential still exists.  Vytorin is simvastatin, together with a medication called ezetimide (Zetia).  It works by blocking the absorption of cholesterol in the intestines.  It shows great reductions in cholesterol levels but there is some debate over whether that translates into fewer cardiovascular events (heart attacks).

Where does this leave you?  It depends on your individual situation.  Step one is to estimate your cardiovascular risk.  If you have known vascular disease (atherosclerosis-partial blockage in any of your arteries), it is imperative that your LDL, bad cholesterol, be less than 100 mg/dl.  This is unlikely to be achieved by diet alone. A statin drug has the best data in regards to lowering your future risk.  If you have diabetes you fall into that same risk category.  If neither of the two are present, go to the Framingham Risk Calculator (click here) and if your risk is above 10%, you should be on a statin.   If it is lower you need to ask yourself if you are truly doing everything you can in regards to diet and exercise to ensure that you remain healthy.   Healthy living is preferable to medications any day of the week as long as the proper levels are attained.

If you need to take a statin medication, the good news is that if you have been taking simvastatin at 40 mg or less and are doing well on it, there is no concern about staying on that dose.  If you take 80 mg of simvastatin or you are also taking any of the medications that interact with it, you should discuss this with your physician.  For a detailed summary from the FDA and a list of all medications that can interact with simvastatin (click here).  If you have any questions, feel free to ask in the comments.  I'll be happy to respond.  Remember, these medications are there only to assist your own efforts in eating right and getting plenty of exercise.  They do not take their place.  Let's just simply be healthy!