Livalo: Late Addition to a Crowded Statin Market. Why Bother?

When I heard that Livalo was being promoted as the newest statin to market I first wondered why anyone would bother to bring a newer drug to a field of excellent drugs many of which have been around long enough to be available as inexpensive generics.  The primary sales pitch of the Kowa-Lilly reps seems to be that this is “mg. for mg. the most potent statin” available.  By this they mean that per mg. of dosing it lowers LDL cholesterol more than any other statin.  Anyone who understands pharmacology at all immediately recognizes this as meaningless statement.  Every drug has its appropriate dose, and comparing the number of milligrams of one drug to the number of mg. of another drug is just silly.  In essentially every class of drugs each medication has its own appropriate dose and comparing the dose in mg of one drug to another, and saying that the drug with the lower mg dose is more potent is just ridiculous.

Livalo has a number of things going against it and at this point I cannot think of a single reason I would prescribe it unless someone can show it to have unique benefits as compared to more established statins.  Here are my concerns and reasoning:

• No Better at Lowering LDL: Livalo is promoted by its manufacturer to be equally effective at lowering LDL cholesterol at its medium and highest doses to atorvastatin (Lipitor) and Simvastatin (Zocor).  Average LDL reductions as follows:
  • Livalo 2 mg = 38 – 39% reduction
  • Atorvastatin 10 mg = 38% reduction
  • Simvastatin 20 mg = 35% reduction
  • Livalo 4 mg = 44-45% reduction
  • Atorvastatin 20 mg = 44% reduction
  • Simvastatin 40 mg = 43% reduction
  • Atovastatin 40 and 80 mg dosing not compared to Livalo.
• No Data for Cardiovascular Outcomes:  Livalo has no data for primary efficacy at reducing cardiovascular morbidity or mortality.  This type of data is well established for simvastatin and atorvastatin.  This is a big deal.  Why use a drug with no reason to expect superior efficacy that lacks data to even be confident it has any efficacy at the real desired outcome.
•  High Price for Many Years:  Livalo has just been released to market.  It is priced at drugstore.com at 115.99/ 30 tablets.  This compares to simvastatin 20  at $5.90/ 30 tablets  at Costco (no Livalo price online at Costco, likely because there is so little market demand).  Generic Lipitor (atorvastatin) will become available as a generic late this year, and is currently available at Costco at $165.70/ 30 tablets.  All told the generic statins are appropriate for the vast majority of patients.
• Safety Data Pending:  Why use a drug with no apparent advantages immediately after it comes to market.  All of us remember the fiascos of many newly released drugs when they became available to the mass market and serious problems came to light.  (Think Ketek and Vioxx)

Livalo seems to have a side effects profile very similar to the currently available statins.  If there is a lower incidence of myalgias and myositis there may turn out to be a niche role for Livalo, but at this time I’ll wait to see a lot larger experience than the studies presented so far.

Summary on Livalo:  A simply Ho-Hum new drug that I plan to forget the name of as soon as I finish this post.  Stick with either a good generic like simvastatin.  If you need a branded drug use one with more post-market experience and the promise of being available as a generic very soon like Lipitor.  Overall the Simvastatin vs Lipitor debate leans towards simvastatin until Lipitor becomes generic.  Then I anticipate atorvastatin to be the stain of choice for most patients.  For the patient who has mild to moderate myalgias on either of these two drugs, consider a very low dose of pravastatin or even red yeast rice.