Death knell for simvastatin

Simvastatin is a great drug, one I happen to take.  But new restrictions on its use are going to pluck it right off of doctors’ prescription pads.  It’s not the recommendation against using the highest dose (80 mg) that’s going to deliver the death blow; it’s the restrictions on its use with other common drugs.

The FDA’s new warnings on simvastatin restrict its use with many other common drugs, including a couple of commonly used antibiotics such as erythromycin.  That’s not too difficult—people only take antibiotics for short periods of time.  But its use is also limited with some popular heart medications, and since simvastatin is often used in patients with heart disease, this will be a problem.  For example, amlodipine, a popular blood pressure medication marketed as Norvasc, can raise levels of simvastatin.  New recommendations cap simvastatin at 20 mg for patients on amlodipine.

None of these individual recommendations are that difficult to follow, but given our wide range of choices for statins, physicians will have fewer reasons to deal with the hassle.  Why prescribe 40 mg of simvastatin when 40 mg of pravastatin may do just as well (and doesn’t carry similar warnings)?  If you suspect your patient is going to eventually need a high dose, why not just bite the bullet and prescribe a branded statin such as atorvastatin (Lipitor) or rosuvastatin (Crestor)?  They are both more potent, and atorvastatin will soon lose its patent.

I can easily see physicians restricting simvastatin to patients with mildly elevated cholesterol and those without too many other medical problems requiring drugs that may interact unfavorably.

Simva, I still like you, but your market share is about to tank.

9 Comments

  1. Alexis

     /  June 11, 2011

    why not just bite the bullet and prescribe a branded statin such as atorvastatin (Lipitor) or rosuvastatin (Crestor)?

    Stating the obvious–cost. Some patients do pay for their own prescriptions or have high copays for branded drugs, although I just checked and simvastatin is not on the $4 list. (Pravastatin and lovastatin are.) I know this isn’t true for everyone, but the difference between an $8 (or $4) copay and a $35 one (or, for Crestor, $70) every month, does matter to me–I have 5 prescriptions to fill. My mother has no health insurance; brand drugs are simply out of the question.

  2. PalMD

     /  June 11, 2011

    You’re correct about the pricing. So far, none of the more potent statins has gone generic, but one will shortly.

    Most of my patients don’t need the more potent, branded statins, but many do.

  3. SurgPA

     /  June 11, 2011

    “I can easily see physicians restricting simvastatin to patients with mildly elevated cholesterol and those without too many other medical problems requiring drugs that may interact unfavorably.”

    One could argue that this group of people you describe don’t gain much benefit from cholesterol-lowering in terms of primary prevention. Obviously there has to be a threshhold LDL above which drug is indicated, but it gets harder to justify prescribing simvastatin, given the increased recognition of risk (I can see the new round of law-firm tv commercials already in production. ) As you say, once atorvastatin comes off-patent, simvastatin is a goner.

  4. The Blind Watchmaker

     /  June 11, 2011

    And thanks to the media’s “go-to” guy for scarring the daylights out of patients, Dr. Steven Nissen, the panic has started. He was on ABC news Thursday night telling everyone about how simva kills all of your muscle cells. Very little risk/benefit talk.

    I have fielded several calls yesterday to talk heart patients with serious disease off the ledge.

  5. bsci

     /  June 11, 2011

    To state the obvious, why would simvistatin have different risks than the other statins? The multi-drug interactions sound like things that would affect any statin. Is the big difference that simvastatin requires larger does to cause the same effect on cholesterol? Do you think this is just a prelude to more warnings on all statins?

    • Different statins are chemically different, more or less hydro/lipophilic, metabolized by different CYPs, etc.

  6. Chelsea

     /  June 12, 2011

    I had no problems with high dose simvastin, eighty, except cost concerns eventually. I still had to be on Zetia with that also. Prior to being on simvastin I was on atorvastatin, but had liver elevations, and incidentally caught pulmonary inflammation/fibrosis. Those were perhaps contributed in part to the lipitor probably in conjunction with methotrexate and a prescription nsaid. Lowered the methotrexate, switched nsaid, switched the lipitor to zocor and all went back to normal. Who knows? Darn though, I was looking for simvastin to get on the four dollar list.

  7. Karen

     /  June 13, 2011

    I’ve been on simvastatin for years without side effects. It does a fine job on cholesterol, though I supplement it with a low-fat diet. I’d be sad to see it disappear and be replaced with something that requires a much higher copay.

  8. Melissa G

     /  June 15, 2011

    Blergh. With my family history of high cholesterol and heart disease, and the fact that diet alone has never gotten my cholesterol below 200, I’m just marking time until I get put on statins for life. The only drug interaction I’m worried about is with my mood stabilizer, as I have really enjoyed mental health. 😉 Hopefully my doc will be up on all the relevant literature when the time comes for me to get statinized. Er, to join the statinic cult? 😀

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