Simvastatin vs. Lipitor – New Restrictions Make it a Different Equation

Simvastatin vs. Lipitor:  Now a whole new decision based on the recent FDA restrictions on simvastatin 80 mg dosing. Yesterday I posted a brief article about the new announcement of the FDA restrictions on the use of simvastatin 80 mg.  Some patients, especially those with diabetes or preexisting atherosclerotic vascular disease, have LDL goals that are really low.  There is some evidence that pushing LDL levels as low as 70 or lower can prevent progression or even possibly reverse this vascular disease.  For many patients in order to achieve these levels a reduction of 40-50% or more in their baseline LDL cholesterol level is needed.  In order to achieve this degree of LDL lowering one of the more potent statin regimens is often needed.

Simvastatin was the third of the currently used statins to lose its patent and become available as a generic drug.  First generic was lovastatin, generic for Mevacor.  Mevacor was the first statin medication to gain FDA approval in the U.S.  It was somewhat slow to gain widespread use as it took some time for data to become available about the benefits of statin use to lower LDL cholesterol.  By the time statin used became widespread statins with greater effect on LDL reduction became available.  Pravachol (Pravastatin) and Zocor (simvastatin) followed Mevacor to market.  Shortly after Zocor became available Lipitor came to market.  Lipitor zoomed to become the market leader based on a number of factors.  One of the factors was the greater LDL reduction available with Lipitor.  In head to head comparison of simvastatin vs. Lipitor, Simvastatin has a considerably more modest LDL reduction.  See the table below.  In addition Lipitor was featured in several high profile studies which vaulted the popularity of statins for both secondary and primary prevention of coronary artery disease.

Lipitor, a Pfizer product,  is the number one grossing drug in the world, with over $10 billion in sales in 2010.  Simvastatin reclaimed a huge portion of statin sales in 2009 when generic simvastatin became available, in part because at the top dose of 80 mg simvastatin’s LDL reduction approaches the LDL reduction possible with lower doses of Lipitor.  The news this week that the FDA is limiting the use of simvastatin 80 mg is going to make the simvastatin vs. Lipitor/atorvastatin choice lean much more toward Lipitor/atorvastatin.  On Nov 30, 2011 a generic for atorvastatin is going to become available.  Despite this I anticipate another 6 months, when multiple generic companies can market atorvastatin before generic atorvastatin prices drop to the range of the other generic statins.  The apparent lack of an abnormally high incidence of myopathy as a lipitor side effect is going to drive this change.

Still that’s only a year from now, and the simvastatin vs. Lipitor choice is now one I can realistically entertain, knowing that the price excess of Lipitor is soon to disappear.  I’ll consider changing my simvastatin 80 mg patients to Lipitor now, and generic atorvastatin when it becomes available unless they have been stable and symptom free for a long period of time.  The FDA recommends change unless a patient has tolerated simvastatin 80 mg for over a year.  This is because most cases of myopathy and rhabdomyolysis from simvastatin 80 mg happen in the first year of use.  I’ll still consider low dose simvastatin for patients who need only a more modest reduction in LDL reduction, but I expect atorvastatin to quickly become the most widely used statin after it competes in price with simvastatin.
In the long run the simvastatin vs. Lipitor choice looks like one that Lipitor, soon to be generic atorvastatin, is going to win by a runaway.  I’ll report back in a couple of years to let you know if I’m right.

Expect 30-40% LDL Reduction Simvastatin 20 mg Atorvastatin 10 mg
Expect 40-45% LDL Reduction Simvastatin 40 mg Atorvastatin 20 mg
Expect 45-50% LDL Reduction Simvastatin 80 mg Atorvastatin 40 mg
Expect 50-55% LDL Reduction Atorvastatin 80 mg




10 Responses to Simvastatin vs. Lipitor – New Restrictions Make it a Different Equation

  1. Winston: Your goal LDL may vary based on lots of variables. Do you have known vascular disease, diabetes, other high risk issues? If so maybe your goal is <70 LDL. You need to discuss this with your doctor. Keep trying to get in touch with him, but you need something different if you have side effects on the atorvastatin 80mg. DrP.

  2. My LDL just went from 102 to 106 with total 176.
    Been on Simvastatin 40 for 2 years with no problems.
    dr. Just changed me to Atrovastatin 80 and It is giving me muscle aches, heart palpitations and head aches. I can not get in touch with Dr. About this and I think that this dosage is quite radical and potentially dangerous. Would like your input.

  3. David: Per the recent FDA alert the maximum dose of simvastatin to use with amlodapine is 20 mg. I’d have recommended you change too. Rosuvastatin is at least as good at lowering triglycerides as simvastatin. DrP.

  4. I’m taking 80mg simvstatin in the PM and 20 mg amlodapine inthe AM for over one year now with no problems so far. The VA hos wants change the sim. to ROSVASTATIN 20mg. Will this change better control tri’gs?

    Dave Lang Disabled Vet USMC
    ps I do have Diabeties T2

  5. Dr. Pullen:

    You may have already noted this in newer articles but in addition to the restrictions on the 80 mg dose of simvastatin there are also newer restriction on the dose with certain medications (i.e., amlodipine, diltiazem, verapamil, amiodarone).

    In these cases simvastatin dose must now be limited to 10mg or 20mg, depending on which of the above medications is being co-administered.

    Maragret: no concern over the diabetes risk. However, atenolol can lower the actual amount of simvastatin in your body (it’s complicated, but it’s a liver-metabolism thing).

    The good news? It’s not really clinically significant. In short, I wouldn’t lose any sleep over it. However, if your cholesterol numbers start to rise a bit that may be why.


  6. I know of no drug interaction issues with simvastatin and atenolol. Consult your pharmacist for other specific issues. –DrP

  7. I take Simvistatin in the PM and take Atenolol in the AM. I heard you should not take Simvistatin with certain other drugs. Any suggestions?
    Thank you!

  8. Margaret: is a forum where I present information I hope to be useful, but for specific medical advice you should consult your health care provider. Simvastatin is an excellent statin, and the FDA restriction was limited only to high dose, simvastatin 80 mg. Simvastatin is used to lower LDL cholesterol and does not address blood sugar levels significantly.

  9. I have been taking Simvastatin 20mg & now I am beginning to be a diabetic. Should I keep taking this medicine? Before this my numbers ranged around 96 – 98. Last AIC was 102 and I checked it his AM and it was 127.

  10. Excellent article, however here in JAMAICA, a nunber doctors, get excellent LDL reductions by using combinations rather than very high doses of the individual STATINS. Not withstanding the unhelpful reports on NIACIN and exetimide.

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